Evaluation of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of EDP-788
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 2/7/2015 |
| Start Date: | August 2014 |
| Contact: | Dane R Eckols |
| Email: | Dane.Eckols@ppdi.com |
| Phone: | 512-747-2985 |
A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Safety, Tolerability, and Pharmacokinetic Study of EDP-788 in Healthy Adult Volunteers
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.
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.
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).
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).
Key Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
1
site
Click here to add this to my saved trials
