[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100345913":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":11,"locations":30,"responsibleParty":44,"collaborators":46,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":11,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":54,"conditions":66,"keywords":68,"overallStatus":70,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Enanta Pharmaceuticals, Inc","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EDP-305 and Oral Contraceptive","EXPERIMENTAL",null,[13,14],"Drug: EDP-305","Drug: Oral Contraceptive",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"DRUG","EDP-305","Subjects will receive EDP-305 on on Days 11 through 21 of cycle 3",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Oral Contraceptive","Subjects will receive active Oral Contraceptive on Days 1-21 and inert OC on Days 22-28 of cycles 1, 2 and 3",[9],[26],"ethinyl estradiol [EE] and norgestimate [NGM])",[28],{"name":5,"affiliation":5,"role":29},"STUDY_DIRECTOR",[31],{"facility":32,"status":11,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":11},"Covance Clinical Research Unit","Madison","Wisconsin","53704","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-89.40123,43.07305,{"lat":42,"lon":41},{"type":45,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[47],{"name":48,"class":6},"Covance","100345913","phase-1-a-drug-drug-interaction-study-to-investigate-the-effect-of-coadministration-of-edp-305-on-the-pk-of-a-combined-oral-contraceptive-in-healthy-female-subjects-100345913",false,"NCT03783897","A Drug-drug Interaction Study to Investigate the Effect of Coadministration of EDP-305 on the PK of a Combined Oral Contraceptive in Healthy Female Subjects","A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of EDP 305 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Adult Female Subjects","Inclusion Criteria:\n\n* Females of childbearing potential, 18 to 45 years of age, inclusive. Follicle-stimulating hormone levels may be used to confirm premenopausal status, including females who have had a hysterectomy with ovaries still intact. Women who otherwise meet inclusion criteria and who have had tubal ligation, tubal occlusion, or bilateral salpingectomy will be allowed.\n* Body mass index between 18.0 and 32.0 kg\u002Fm2, inclusive.\n* In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations at Screening and Day -1 of the Lead-in Period\n* Must not be pregnant or lactating, and must agree to use contraception\n* Subjects must have documentation of normal results of up-to-date cervical cancer screening as specified in the American College of Obstetricians and Gynecologists guidelines:\n\n  1. Women aged \\\u003C 21 years: no documentation required\n  2. Women aged 21 to 29: normal Pap smear test result within previous 3 years\n  3. Women aged 30 to 45: normal Pap smear test result and negative high-risk human papilloma virus test within previous 5 years, OR normal Pap smear test result within previous 3 years If documented results are not available at Screening, the subject must provide documentation of normal results prior to Day -1 of the Lead-in Period.\n* Able to comprehend and willing to sign an ICF.\n* Willing and able to adhere to assessments, prohibitions, and restrictions as described in this protocol.\n\nExclusion Criteria:\n\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).\n* Are pregnant, breastfeeding, or are planning to conceive during the study.\n* Have been administered injectable contraceptives within 12 months prior to Day -1 of the Lead in Period, or had exposure to a hormonal intrauterine device or topical controlled delivery contraceptives (patch) within 3 months prior to Day -1 of the Lead-in Period.",true,"FEMALE","18 Years","45 Years",{"count":61,"type":62},43,"ACTUAL","INTERVENTIONAL",[65],"PHASE1",[67],"NASH - Nonalcoholic Steatohepatitis",[69],"OC DDI, drug-drug interaction, oral contraceptive","COMPLETED","2019-07-23",{"date":73,"type":62},"2019-07-24",{"date":75,"type":62},"2018-11-27",{"date":77,"type":62},"2019-06-18",{"name":5,"class":6},1]