Clinical trial 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
Official title: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: NASH - Nonalcoholic Steatohepatitis
Keywords: OC DDI, drug-drug interaction, oral contraceptive
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: Covance
First posted: 2018-12-21
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 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.

Primary outcomes:
measure: Area under the plasma concentration-time (AUC0-τ) curve for OC with and without coadministration with EDP-305
timeFrame: Day 21 (cycle 2 and cycle 3)
measure: Cmax for OC with and without coadministration with EDP-305
timeFrame: Day 21 (cycle 2 and cycle 3)
Secondary outcomes:
measure: Area under the plasma concentration-time (AUC0-τ) curve for EDP-305 when coadministration with OC
timeFrame: Days 14, 20-22 (cycle 3)
measure: Cmax for EDP-305 when coadministration with OC
timeFrame: Days 14, 20-22 (cycle 3)
measure: Safety measured by adverse events
timeFrame: Approximately 91 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References: