NASH - Nonalcoholic Steatohepatitis
Conditions
Keywords
OC DDI, drug-drug interaction, oral contraceptive
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
Interventions
DRUGEDP-305
Subjects will receive EDP-305 on on Days 11 through 21 of cycle 3
DRUGOral Contraceptive
Subjects will receive active Oral Contraceptive on Days 1-21 and inert OC on Days 22-28 of cycles 1, 2 and 3
Sponsors
Covance
Enanta Pharmaceuticals, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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: 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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed