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
Overview
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
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Basic Science
- Masking: None (Open Label)
- Study Primary Completion Date: June 4, 2019
Interventions
- Drug: EDP-305
- Subjects will receive EDP-305 on on Days 11 through 21 of cycle 3
- Drug: 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
Arms, Groups and Cohorts
- Experimental: EDP-305 and Oral Contraceptive
Clinical Trial Outcome Measures
Primary Measures
- Area under the plasma concentration-time (AUC0-τ) curve for OC with and without coadministration with EDP-305
- Time Frame: Day 21 (cycle 2 and cycle 3)
- Cmax for OC with and without coadministration with EDP-305
- Time Frame: Day 21 (cycle 2 and cycle 3)
Secondary Measures
- Area under the plasma concentration-time (AUC0-τ) curve for EDP-305 when coadministration with OC
- Time Frame: Days 14, 20-22 (cycle 3)
- Cmax for EDP-305 when coadministration with OC
- Time Frame: Days 14, 20-22 (cycle 3)
- Safety measured by adverse events
- Time Frame: Approximately 91 days
Participating in This Clinical Trial
Inclusion Criteria
- 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: 1. Women aged < 21 years: no documentation required 2. Women aged 21 to 29: normal Pap smear test result within previous 3 years 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. – 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 Criteria:
- 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.
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- Collaborator
- Covance
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Enanta Pharmaceuticals, Inc, Study Director, Enanta Pharmaceuticals, Inc
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