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



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 45
Updated:12/23/2018
Start Date:November 27, 2018
End Date:April 2019
Contact:Enanta Pharmaceuticals, Inc
Email:nadda@enanta.com
Phone:617 607 0705

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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

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.
We found this trial at
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Madison, Wisconsin 53718
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