Evaluation of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of EDP-788
- Registration Number
- NCT02255968
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- Brief Summary
The primary objective of the study is to determine the safety and tolerability of multiple doses of orally administered EDP-788. Secondary objectives of the study are to describe the pharmacokinetics of EDP-788 (and its metabolite EDP-322) after multiple doses of orally administered drug.
- Detailed Description
Three cohorts of subjects will be enrolled to receive either EDP-788 or placebo. The dose of EDP-788 will be increased with each successive cohort. In addition, a 4th cohort may be enrolled, depending on clinical findings (tolerability, safety, pharmacokinetics) observed in the first 3 cohorts. In each cohort, 8 subjects will receive a q12h oral dose regimen of EDP-788 (6 subjects) or placebo (2 subjects). All subjects receive multiple doses of study drug (EDP-788 or placebo).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- In good general health
- BMI between 18 - 32 kg/m2
- Women must be of non-childbearing potential (surgically sterilized)
- Normal electrocardiogram
- Willing to abstain from strenuous physical exercise starting 3 days prior to admission to the study clinic through the 17 - 19 day post-dosing visit
Key
- Hypersensitivity to macrolide antibiotics
- Abnormal laboratory values
- Gastroenteritis within 1 week of study drug administration
- Use of any investigational drugs within 28 days of study drug administration
- History of gastrointestinal surgery which may interfere with drug absorption
- Active Hepatitis B, Hepatitis C, or HIV infection
- Use of prescription or non-prescription drugs within 14 days of study drug administration
- Use of nicotine within 3 months of study drug administration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Multiple doses with dose escalation to continue in successive cohorts EDP-788 EDP-788 Multiple doses with dose escalation to continue in successive cohorts
- Primary Outcome Measures
Name Time Method Incidence and severity of adverse events From time of dosing to 20-23 days after receiving last dose of study drug
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters From time of dosing to 3 days after receiving the last dose of study drug As measured by peak plasma concentration (Cmax)
Changes from baseline in laboratory values and vital signs From time of dosing to 20-23 days after receiving last dose of study drug
Trial Locations
- Locations (1)
PPD Phase 1 Clinic
🇺🇸Austin, Texas, United States