Status:
COMPLETED
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
Lead Sponsor:
Enanta Pharmaceuticals, Inc
Collaborating Sponsors:
Covance
Conditions:
NASH - Nonalcoholic Steatohepatitis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
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
Eligibility Criteria
Inclusion
- 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.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- 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
- Must not be pregnant or lactating, and must agree to use contraception
- 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:
- Women aged \< 21 years: no documentation required
- Women aged 21 to 29: normal Pap smear test result within previous 3 years
- 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.
- Able to comprehend and willing to sign an ICF.
- Willing and able to adhere to assessments, prohibitions, and restrictions as described in this protocol.
Exclusion
- 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).
- Are pregnant, breastfeeding, or are planning to conceive during the study.
- 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.
Key Trial Info
Start Date :
November 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2019
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03783897
Start Date
November 27 2018
End Date
June 18 2019
Last Update
July 24 2019
Active Locations (1)
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1
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53704