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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.