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

Sponsor

Enanta Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT03783897

Collaborator

Covance (Industry)

Enrollment

Location

Arm

6.7

Actual Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
NASH - Nonalcoholic Steatohepatitis	Drug: EDP-305 Drug: Oral Contraceptive	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Nov 27, 2018

Actual Primary Completion Date :

Jun 4, 2019

Actual Study Completion Date :

Jun 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EDP-305 and Oral Contraceptive	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 Other Names: ethinyl estradiol [EE] and norgestimate [NGM])

Arm

Intervention/Treatment

Experimental: EDP-305 and Oral Contraceptive

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

Other Names:

ethinyl estradiol [EE] and norgestimate [NGM])

Outcome Measures

Primary Outcome Measures

Area under the plasma concentration-time (AUC0-τ) curve for OC with and without coadministration with EDP-305 [Day 21 (cycle 2 and cycle 3)]
Cmax for OC with and without coadministration with EDP-305 [Day 21 (cycle 2 and cycle 3)]

Secondary Outcome Measures

Area under the plasma concentration-time (AUC0-τ) curve for EDP-305 when coadministration with OC [Days 14, 20-22 (cycle 3)]
Cmax for EDP-305 when coadministration with OC [Days 14, 20-22 (cycle 3)]
Safety measured by adverse events [Approximately 91 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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:

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 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.