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
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
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
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.