Status:
TERMINATED
Evaluation of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of EDP-788
Lead Sponsor:
Enanta Pharmaceuticals, Inc
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 ...
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...
Eligibility Criteria
Inclusion
- Key
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02255968
Start Date
August 1 2014
End Date
October 1 2014
Last Update
May 12 2015
Active Locations (1)
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1
PPD Phase 1 Clinic
Austin, Texas, United States, 78744