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

NASH - Nonalcoholic Steatohepatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03783897
• Other study ID #: EDP 305-008
• Status: Completed
• Phase: Phase 1
• Start date: November 27, 2018
• Est. completion date: June 18, 2019

Study information

• Verified date: July 2019
• Source: Enanta Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 18, 2019
• Est. primary completion date: June 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• EDP-305
Subjects will receive EDP-305 on on Days 11 through 21 of cycle 3
• 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

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals	Covance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time (AUC0-t) curve for OC with and without coadministration with EDP-305		Day 21 (cycle 2 and cycle 3)
Primary	Cmax for OC with and without coadministration with EDP-305		Day 21 (cycle 2 and cycle 3)
Secondary	Area under the plasma concentration-time (AUC0-t) curve for EDP-305 when coadministration with OC		Days 14, 20-22 (cycle 3)
Secondary	Cmax for EDP-305 when coadministration with OC		Days 14, 20-22 (cycle 3)
Secondary	Safety measured by adverse events		Approximately 91 days