[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100296556":3},{"organization":4,"armGroups":7,"interventions":66,"overallOfficials":72,"centralContacts":72,"locations":81,"responsibleParty":452,"collaborators":72,"id":454,"slug":455,"hasResults":456,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":72,"eligibilityCriteria":460,"healthyVolunteers":461,"sex":462,"minAge":463,"maxAge":72,"enrollmentInfo":464,"targetDuration":72,"studyType":467,"phases":468,"briefSummary":470,"conditions":471,"keywords":72,"overallStatus":474,"whyStopped":72,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":483},{"fullName":5,"class":6},"Proteostasis Therapeutics, Inc.","INDUSTRY",[8,14,19,23,26,30,34,37,41,44,49,52,56,59,63],{"label":9,"type":10,"description":11,"interventionNames":12},"SAD HV PTI-801 Active - Complete","ACTIVE_COMPARATOR","The safety, tolerability, and pharmacokinetic profile of PTI-801 will be evaluated following a single dose of PTI-801. Three cohorts are planned for evaluation where subjects will be randomized to PTI-801 or placebo.The subjects will be followed for 7 days post dose.",[13],"Drug: PTI-801",{"label":15,"type":16,"description":11,"interventionNames":17},"SAD HV PTI-801 Placebo - Complete","PLACEBO_COMPARATOR",[18],"Drug: Placebo",{"label":20,"type":10,"description":21,"interventionNames":22},"MAD HV PTI-801 Active - Complete","Following the conclusion of the respective SAD level dose groups and after sufficient review of study data and approval by the SRC, a second set of healthy adult subjects will participate in an assigned MAD treatment group. The MAD treatment group is comprised of 3 cohorts. Subjects will be randomized to either PTI-801 or placebo. Each dose will be administered once daily (QD) for a total of 7 days. Follow up visits will occur on Days 10, 12 and 14.",[13],{"label":24,"type":16,"description":21,"interventionNames":25},"MAD HV PTI-801 Placebo - Complete",[18],{"label":27,"type":10,"description":28,"interventionNames":29},"FE HV PTI-801 Active - Complete","Following the conclusion of SAD groups and after sufficient review of study data and approval by the SRC, a third set of healthy adult subjects will participate in the Food Effect cohort. Subjects will be randomized to Fed or Fasted on Days 1 and 12. Follow up visits will occur 7 days post Day 12 dose.",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"DDI HV PTI-801 Active - Complete","Following the conclusion of HV MAD Cohort 2 and after sufficient review of study data and approval by the SRC, a fourth set of healthy adult subjects will participate in the Drug-Drug Interactions cohort. Subjects will receive a 3-drug cocktail consisting of caffeine, bupropion, and midazolam on Day 1. On Day 4, subjects will be randomized to receive either PTI-801 or placebo QD for a total of 12 days. On Day 17, subjects will receive the 3-drug cocktail in combination with PTI-801 or placebo. Subjects will remain in clinic until Day 20. A follow up visit will occur on Day 24.",[13],{"label":35,"type":16,"description":32,"interventionNames":36},"DDI HV PTI-801 Placebo - Complete",[18],{"label":38,"type":10,"description":39,"interventionNames":40},"MAD Cohort 1-3 CF PTI-801 Active - Complete","Adult subjects diagnosed with CF currently on stable ivacaftor\u002Flumacaftor background therapy for a minimum of three months will participate in the Part 2 complementary CF MAD cohort. The CF MAD treatment group is comprised of 3 cohorts. Subjects will be randomized to receive either PTI-801 or placebo QD for a total of 14 days. A follow up visit will occur on Day 21.",[13],{"label":42,"type":16,"description":39,"interventionNames":43},"MAD Cohort 1-3 CF PTI-801 Placebo - Complete",[18],{"label":45,"type":10,"description":46,"interventionNames":47},"Cohort 4 CF PTI-801 Active co-admin PTI-808 Active - Complete","Adult subjects diagnosed with CF not currently receiving a CFTR modulator therapy within 30 days prior to Day 1 will participate in the Part 2 CF Cohort 4. Subjects will be randomized to receive either PTI-801 co-administered with PTI-808 or placebos QD.",[13,48],"Drug: PTI-808",{"label":50,"type":16,"description":46,"interventionNames":51},"Cohort 4 CF PTI-801 Placebo co-admin PTI-808 Placebo- Complete",[18],{"label":53,"type":10,"description":54,"interventionNames":55},"Cohort 5 CF PTI-801 Active co-admin with PTI-808 Active","Adult subjects diagnosed with CF not currently receiving a CFTR modulator therapy within 30 days prior to Day 1 will participate in the Part 2 CF Cohort 5. Subjects will be randomized to receive either PTI-801 co-administered with PTI-808 or placebos QD.",[13,48],{"label":57,"type":16,"description":54,"interventionNames":58},"Cohort 5 CF PTI-801 Placebo co-admin with PTI-808 Placebo",[18],{"label":60,"type":10,"description":61,"interventionNames":62},"Cohort 6 CF PTI-801 Active","Adult subjects diagnosed with CF currently on stable tezacaftor\u002Fivacaftor background therapy for a minimum of one month will participate in the Part 2 complementary CF MAD cohort. Subjects will be randomized to receive either PTI-801 or placebo QD.",[13],{"label":64,"type":16,"description":61,"interventionNames":65},"Cohort 6 CF PTI-801 Placebo",[18],[67,73,76,79],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"DRUG","PTI-801","Active",[45,53,60,31,27,38,20,9],null,{"type":68,"name":74,"description":74,"armGroupLabels":75,"otherNames":72},"Placebo",[50,57,64,35,42,24,15],{"type":68,"name":77,"description":70,"armGroupLabels":78,"otherNames":72},"PTI-808",[45,53],{"type":68,"name":74,"description":74,"armGroupLabels":80,"otherNames":72},[50,57],[82,95,105,115,125,135,144,153,163,173,182,192,202,212,218,228,238,248,258,267,273,282,292,302,311,320,330,340,349,359,369,378,388,398,410,419,430,441],{"facility":83,"status":72,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":72},"University of Alabama at Birmingham","Birmingham","Alabama","35233","United States","US",{"type":90,"coordinates":91},"Point",[92,93],-86.80249,33.52066,{"lat":93,"lon":92},{"facility":96,"status":72,"city":97,"state":98,"zip":99,"country":87,"countryCode":88,"cosmosGeoPoint":100,"geoPoint":104,"contacts":72},"Providence Alaska Medical Center","Anchorage","Alaska","99508",{"type":90,"coordinates":101},[102,103],-149.90028,61.21806,{"lat":103,"lon":102},{"facility":106,"status":72,"city":107,"state":108,"zip":109,"country":87,"countryCode":88,"cosmosGeoPoint":110,"geoPoint":114,"contacts":72},"Stanford University Medical Center","Stanford","California","94305",{"type":90,"coordinates":111},[112,113],-122.16608,37.42411,{"lat":113,"lon":112},{"facility":116,"status":72,"city":117,"state":118,"zip":119,"country":87,"countryCode":88,"cosmosGeoPoint":120,"geoPoint":124,"contacts":72},"National Jewish Health","Denver","Colorado","80206",{"type":90,"coordinates":121},[122,123],-104.9847,39.73915,{"lat":123,"lon":122},{"facility":126,"status":72,"city":127,"state":128,"zip":129,"country":87,"countryCode":88,"cosmosGeoPoint":130,"geoPoint":134,"contacts":72},"Central Florida Pulmonary Group","Altamonte Springs","Florida","32803",{"type":90,"coordinates":131},[132,133],-81.36562,28.66111,{"lat":133,"lon":132},{"facility":136,"status":72,"city":137,"state":128,"zip":138,"country":87,"countryCode":88,"cosmosGeoPoint":139,"geoPoint":143,"contacts":72},"University of Florida College of Medicine","Gainesville","32610",{"type":90,"coordinates":140},[141,142],-82.32483,29.65163,{"lat":142,"lon":141},{"facility":145,"status":72,"city":146,"state":128,"zip":147,"country":87,"countryCode":88,"cosmosGeoPoint":148,"geoPoint":152,"contacts":72},"University of Miami Health System","Miami","33136",{"type":90,"coordinates":149},[150,151],-80.19366,25.77427,{"lat":151,"lon":150},{"facility":154,"status":72,"city":155,"state":156,"zip":157,"country":87,"countryCode":88,"cosmosGeoPoint":158,"geoPoint":162,"contacts":72},"St. Luke's CF Center of Idaho","Boise","Idaho","83712",{"type":90,"coordinates":159},[160,161],-116.20345,43.6135,{"lat":161,"lon":160},{"facility":164,"status":72,"city":165,"state":166,"zip":167,"country":87,"countryCode":88,"cosmosGeoPoint":168,"geoPoint":172,"contacts":72},"Northwestern University Memorial Hospital","Chicago","Illinois","60611",{"type":90,"coordinates":169},[170,171],-87.65005,41.85003,{"lat":171,"lon":170},{"facility":174,"status":72,"city":175,"state":166,"zip":176,"country":87,"countryCode":88,"cosmosGeoPoint":177,"geoPoint":181,"contacts":72},"OSF Saint Francis Medical Center","Peoria","61637",{"type":90,"coordinates":178},[179,180],-89.58899,40.69365,{"lat":180,"lon":179},{"facility":183,"status":72,"city":184,"state":185,"zip":186,"country":87,"countryCode":88,"cosmosGeoPoint":187,"geoPoint":191,"contacts":72},"University of Iowa","Iowa City","Iowa","52242",{"type":90,"coordinates":188},[189,190],-91.53017,41.66113,{"lat":190,"lon":189},{"facility":193,"status":72,"city":194,"state":195,"zip":196,"country":87,"countryCode":88,"cosmosGeoPoint":197,"geoPoint":201,"contacts":72},"Maine Medical Center","Portland","Maine","04102",{"type":90,"coordinates":198},[199,200],-70.2589,43.65737,{"lat":200,"lon":199},{"facility":203,"status":72,"city":204,"state":205,"zip":206,"country":87,"countryCode":88,"cosmosGeoPoint":207,"geoPoint":211,"contacts":72},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":90,"coordinates":208},[209,210],-71.05977,42.35843,{"lat":210,"lon":209},{"facility":213,"status":72,"city":204,"state":205,"zip":214,"country":87,"countryCode":88,"cosmosGeoPoint":215,"geoPoint":217,"contacts":72},"Boston Children's Hospital","02115",{"type":90,"coordinates":216},[209,210],{"lat":210,"lon":209},{"facility":219,"status":72,"city":220,"state":221,"zip":222,"country":87,"countryCode":88,"cosmosGeoPoint":223,"geoPoint":227,"contacts":72},"University of Michigan Health System","Ann Arbor","Michigan","48109",{"type":90,"coordinates":224},[225,226],-83.74088,42.27756,{"lat":226,"lon":225},{"facility":229,"status":72,"city":230,"state":231,"zip":232,"country":87,"countryCode":88,"cosmosGeoPoint":233,"geoPoint":237,"contacts":72},"Children's Mercy Kansas City","Kansas City","Missouri","64108",{"type":90,"coordinates":234},[235,236],-94.57857,39.09973,{"lat":236,"lon":235},{"facility":239,"status":72,"city":240,"state":241,"zip":242,"country":87,"countryCode":88,"cosmosGeoPoint":243,"geoPoint":247,"contacts":72},"University of Nebraska Medical Center","Omaha","Nebraska","68198",{"type":90,"coordinates":244},[245,246],-95.94043,41.25626,{"lat":246,"lon":245},{"facility":249,"status":72,"city":250,"state":251,"zip":252,"country":87,"countryCode":88,"cosmosGeoPoint":253,"geoPoint":257,"contacts":72},"Children's Lung Specialists","Las Vegas","Nevada","89107",{"type":90,"coordinates":254},[255,256],-115.13722,36.17497,{"lat":256,"lon":255},{"facility":259,"status":72,"city":260,"state":260,"zip":261,"country":87,"countryCode":88,"cosmosGeoPoint":262,"geoPoint":266,"contacts":72},"Columbia University Medical Center","New York","10001",{"type":90,"coordinates":263},[264,265],-74.00597,40.71427,{"lat":265,"lon":264},{"facility":268,"status":72,"city":260,"state":260,"zip":269,"country":87,"countryCode":88,"cosmosGeoPoint":270,"geoPoint":272,"contacts":72},"Mount Sinai Beth Israel","10003",{"type":90,"coordinates":271},[264,265],{"lat":265,"lon":264},{"facility":274,"status":72,"city":275,"state":260,"zip":276,"country":87,"countryCode":88,"cosmosGeoPoint":277,"geoPoint":281,"contacts":72},"New York Medical College","Valhalla","10595",{"type":90,"coordinates":278},[279,280],-73.77513,41.07482,{"lat":280,"lon":279},{"facility":283,"status":72,"city":284,"state":285,"zip":286,"country":87,"countryCode":88,"cosmosGeoPoint":287,"geoPoint":291,"contacts":72},"Duke University Health System","Durham","North Carolina","27710",{"type":90,"coordinates":288},[289,290],-78.89862,35.99403,{"lat":290,"lon":289},{"facility":293,"status":72,"city":294,"state":295,"zip":296,"country":87,"countryCode":88,"cosmosGeoPoint":297,"geoPoint":301,"contacts":72},"Akron Children's Hospital","Akron","Ohio","44308",{"type":90,"coordinates":298},[299,300],-81.51901,41.08144,{"lat":300,"lon":299},{"facility":303,"status":72,"city":304,"state":295,"zip":305,"country":87,"countryCode":88,"cosmosGeoPoint":306,"geoPoint":310,"contacts":72},"Nationwide Children's Hospital","Columbus","43205",{"type":90,"coordinates":307},[308,309],-82.99879,39.96118,{"lat":309,"lon":308},{"facility":312,"status":72,"city":313,"state":295,"zip":314,"country":87,"countryCode":88,"cosmosGeoPoint":315,"geoPoint":319,"contacts":72},"Toledo Children's Hospital","Toledo","43606",{"type":90,"coordinates":316},[317,318],-83.55521,41.66394,{"lat":318,"lon":317},{"facility":321,"status":72,"city":322,"state":323,"zip":324,"country":87,"countryCode":88,"cosmosGeoPoint":325,"geoPoint":329,"contacts":72},"Santiago Reyes, M.D. P.C.","Oklahoma City","Oklahoma","73112",{"type":90,"coordinates":326},[327,328],-97.51643,35.46756,{"lat":328,"lon":327},{"facility":331,"status":72,"city":332,"state":333,"zip":334,"country":87,"countryCode":88,"cosmosGeoPoint":335,"geoPoint":339,"contacts":72},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":90,"coordinates":336},[337,338],-75.16362,39.95238,{"lat":338,"lon":337},{"facility":341,"status":72,"city":342,"state":333,"zip":343,"country":87,"countryCode":88,"cosmosGeoPoint":344,"geoPoint":348,"contacts":72},"Children's Hospital of Pittsburgh of UPMC","Pittsburgh","15244",{"type":90,"coordinates":345},[346,347],-79.99589,40.44062,{"lat":347,"lon":346},{"facility":350,"status":72,"city":351,"state":352,"zip":353,"country":87,"countryCode":88,"cosmosGeoPoint":354,"geoPoint":358,"contacts":72},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":90,"coordinates":355},[356,357],-79.93275,32.77632,{"lat":357,"lon":356},{"facility":360,"status":72,"city":361,"state":362,"zip":363,"country":87,"countryCode":88,"cosmosGeoPoint":364,"geoPoint":368,"contacts":72},"ICON Early Phase Services","San Antonio","Texas","78209",{"type":90,"coordinates":365},[366,367],-98.49363,29.42412,{"lat":367,"lon":366},{"facility":370,"status":72,"city":371,"state":362,"zip":372,"country":87,"countryCode":88,"cosmosGeoPoint":373,"geoPoint":377,"contacts":72},"University of Texas Health Science Center at Tyler","Tyler","75708",{"type":90,"coordinates":374},[375,376],-95.30106,32.35126,{"lat":376,"lon":375},{"facility":379,"status":72,"city":380,"state":381,"zip":382,"country":87,"countryCode":88,"cosmosGeoPoint":383,"geoPoint":387,"contacts":72},"University of Utah","Salt Lake City","Utah","84132",{"type":90,"coordinates":384},[385,386],-111.89105,40.76078,{"lat":386,"lon":385},{"facility":389,"status":72,"city":390,"state":391,"zip":392,"country":87,"countryCode":88,"cosmosGeoPoint":393,"geoPoint":397,"contacts":72},"Virginia Commonwealth University","Richmond","Virginia","23298",{"type":90,"coordinates":394},[395,396],-77.46026,37.55376,{"lat":396,"lon":395},{"facility":399,"status":72,"city":400,"state":401,"zip":402,"country":403,"countryCode":404,"cosmosGeoPoint":405,"geoPoint":409,"contacts":72},"St. Paul's Hospital","Vancouver","British Columbia","V6Z1Y6","Canada","CA",{"type":90,"coordinates":406},[407,408],-123.11934,49.24966,{"lat":408,"lon":407},{"facility":411,"status":72,"city":412,"state":72,"zip":413,"country":403,"countryCode":404,"cosmosGeoPoint":414,"geoPoint":418,"contacts":72},"Institut Universitaire de Cardiologie et de Pneumologie de Quebec","Québec","G1V 4G5",{"type":90,"coordinates":415},[416,417],-71.21454,46.81228,{"lat":417,"lon":416},{"facility":420,"status":72,"city":421,"state":72,"zip":422,"country":423,"countryCode":424,"cosmosGeoPoint":425,"geoPoint":429,"contacts":72},"University of Copenhagen Rigshospitalet","Copenhagen","2100","Denmark","DK",{"type":90,"coordinates":426},[427,428],12.56553,55.67594,{"lat":428,"lon":427},{"facility":431,"status":72,"city":432,"state":72,"zip":433,"country":434,"countryCode":435,"cosmosGeoPoint":436,"geoPoint":440,"contacts":72},"Charite - Campus Virchow-Klinikum","Berlin","10117","Germany","DE",{"type":90,"coordinates":437},[438,439],13.41053,52.52437,{"lat":439,"lon":438},{"facility":442,"status":72,"city":443,"state":72,"zip":444,"country":445,"countryCode":446,"cosmosGeoPoint":447,"geoPoint":451,"contacts":72},"Stockholm CF Center","Stockholm","141 86","Sweden","SE",{"type":90,"coordinates":448},[449,450],18.06871,59.32938,{"lat":450,"lon":449},{"type":453,"investigatorFullName":72,"investigatorTitle":72,"investigatorAffiliation":72,"oldNameTitle":72,"oldOrganization":72},"SPONSOR","100296556","phase-1-study-assessing-the-safety-tolerability-pharmacokinetics-food-effect-and-drug-drug-interactions-of-pti-801-in-healthy-volunteers-and-safety-tolerability-and-pharmacokinetics-of-pti-801-in-subjects-with-cystic-fibrosis-100296556",false,"NCT03140527","Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis","A Multi-Center, Randomized, Placebo-Controlled, Phase 1, Two-Part Study Designed to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis","Part 1 Inclusion Criteria:\n\n* Adults age 18 to 55 years old, inclusive, at the time of informed consent.\n* Body mass index (BMI) ≥18 to \\\u003C30 kg\u002Fm2.\n* Subject must be a nonsmoker and a nontobacco user for a minimum of 30 days prior to screening and for the duration of the study.\n\nPart 1 Exclusion Criteria:\n\n* History or current evidence of any clinically significant cardiac, endocrinologic,hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic,dermatologic, psychiatric, renal, or other major disease, as determined by the investigator.\n* Presence of prolonged QT\u002F Corrected QT Interval (QTc) interval with Fridericia's correction formula (QTcF) \\>450 msec at screening.\n* Abnormal liver function as defined by aspartate aminotransferase (AST), alanine aminotransferase (ALT) or bilirubin \\> upper limit of the normal range.\n* Abnormal renal function at screening defined as: Creatinine clearance \\\u003C80 mL\u002Fmin using the Cockcroft-Gault equation.\n* Participation in another clinical trial or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to Study Day 1.\n* History of cancer within the past 5 years (excluding nonmelanoma skin cancer).\n* History or current evidence of alcohol or drug abuse or dependence within 12 months of screening as determined by the investigator.\n* Positive urine screen for prohibited drugs (cocaine, cannabinoids, nicotine \\[urine cotinine is the detection mechanism for nicotine\\], opiates, barbiturates, amphetamines, and benzodiazepines) or positive alcohol test at screening.\n* Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCVAb).\n* Has donated blood within 3 months of screening or plans to donate blood within 3 months of study completion.\n\nPart 1 HV DDI Cohort Additional Exclusion Criteria:\n\n* Concomitant use of known strong or moderate inhibitors or inducers of CYP1A2, CYP2B6, and CYP3A4 within 14 days or 5 half-lives (whichever is longer) prior to Day 1 and through the last PK sampling point on Day 20\n* Use of grapefruit- or Seville orange-containing products within 48 hours prior to Day 1 and through the last PK sampling point on Day 20\n* Use of alcohol- or caffeine-containing products within 48 hours prior to Day 1 and through the last PK sampling point on Day 20\n\nPart 2 Inclusion Criteria:\n\n* Confirmed diagnosis of CF with the F508del\u002FF508del genotype on record, along with clinical findings consistent with CF such as chronic sinopulmonary disease or gastrointestinal\u002Fnutritional abnormalities\n* Forced expiratory volume in 1 second (FEV1) 40-90% predicted, inclusive\n* Non-smoker and non-tobacco user for a minimum of 30 days prior to screening\n\nPart 2 Cohorts 1-3 Additional Inclusion Criterion:\n\n* Stable on ivacaftor\u002Flumacaftor dosing for both label indication and per label dosing for a minimum of 3 months at the time of dosing\n\nPart 2 Cohort 6 Additional Inclusion Criterion:\n\n* Stable on tezacaftor\u002Fivacaftor dosing for both label indication and per label dosing for a minimum of 1 month at the time dosing\n\nPart 2 Exclusion Criteria:\n\n* Participation in another clinical trial or treatment with an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to Study Day 1\n* History of cancer within the past 5 years (excluding cervical cancer in situ with curative therapy for at least one year prior to screening and non-melanoma skin cancer)\n* History of organ transplantation\n* Hospitalization, sinopulmonary infection, CF exacerbation, or other clinically significant infection or illness (as determined by the investigator) requiring an increase or addition of medication, such as antibiotics or corticosteroids, within 14 days of Day 1\n* Initiation of any new chronic therapy (e.g., ibuprofen, hypertonic saline, azithromycin, Pulmozyme®, Cayston®, TOBI®)) or any change in chronic therapy (excluding pancreatic enzyme replacement therapy) within 28 days prior to Day 1\n* History or current evidence of alcohol or drug abuse or dependence within 12 months of screening as determined by the investigator\n* Pregnant or nursing women\n\nPart 2 Cohort's 4 and 5 Additional Exclusion Criterion:\n\n* Currently taking or has taken a CFTR modulator within 30 days prior to initial dose of study drugs",true,"ALL","18 Years",{"count":465,"type":466},171,"ACTUAL","INTERVENTIONAL",[469],"PHASE1","This trial will consist of two parts: Part 1 and Part 2. Part 1 will enroll adult healthy volunteers (HV) into four treatment groups. The first group will enroll HV into a single ascending dose (SAD) treatment group consisting of three cohorts. The second group will enroll HV into a multiple ascending dose (MAD) treatment group consisting of three cohorts. The third group will enroll HV into a food effect (FE) treatment group consisting of one cohort. The fourth group will enroll HV into a drug-drug interactions (DDI) treatment group consisting of one cohort. Approximately 76 subjects will be enrolled in Part 1.\n\nPart 2 Cohorts 1 through 3 will enroll adult subjects with cystic fibrosis (CF) currently on stable ivacaftor\u002Flumacaftor background therapy for a minimum of three months. Part 2 Cohorts 4 and Cohort 5 will enroll adult subjects with CF not currently receiving cystic fibrosis conductance regulator (CFTR) modulator therapy within 30 days prior to Day 1. Part 2 Cohort 6 will enroll adult subjects with cystic fibrosis on stable tezacaftor\u002Fivacaftor background therapy. Approximately 104 subjects will be enrolled in Part 2.",[472,473],"Healthy Volunteer","Cystic Fibrosis","COMPLETED","2020-04-28",{"date":477,"type":466},"2020-04-30",{"date":479,"type":466},"2017-04-10",{"date":481,"type":466},"2020-02-27",{"name":5,"class":6},38]