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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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NASH - Nonalcoholic Steatohepatitis

Intervention / Treatment
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* Drug: EDP-305
* Drug: Oral Contraceptive


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EDP-305 and Oral Contraceptive<br> | Drug: EDP-305<br>* Subjects will receive EDP-305 on on Days 11 through 21 of cycle 3<br>Drug: Oral Contraceptive<br>* Subjects will receive active Oral Contraceptive on Days 1-21 and inert OC on Days 22-28 of cycles 1, 2 and 3<br>* Other names: ethinyl estradiol [EE] and norgestimate [NGM]);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OC DDI, drug-drug interaction, oral contraceptive