Evaluation of the Safety and Pharmacokinetics of a Single Oral Dose of EDP-788
The primary objective of the study is to determine the safety of single 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 single doses of orally administered drug
- To estimate the bioavailability of EDP-788 capsules relative to an oral liquid suspension
- To estimate the effect of co-administration of food on the absorption of EDP-788
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Ascending One-Day (Single and Divided Dose) Safety, Tolerability, and Pharmacokinetic Study of EDP-788 in Healthy Adult Volunteers|
- Incidence and severity of adverse events [ Time Frame: From time of dosing to 8 - 10 days after receiving study drug ] [ Designated as safety issue: Yes ]
- Changes from baseline in laboratory values and vital signs [ Time Frame: From time of dosing to 8 - 10 days after receiving study drug ] [ Designated as safety issue: Yes ]
- Pharmacokinetic parameters [ Time Frame: From time of dosing to 3 days after receiving study drug ] [ Designated as safety issue: No ]
|Study Start Date:||January 2014|
|Study Completion Date:||September 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Single doses with dose escalation to continue in successive cohorts
EDP-788 Capsules and matching placebo capsules. EDP-788 Liquid Suspension and matching placebo. All interventions are given as single doses
Placebo Comparator: Placebo
Single dose with matching placebo
Matching placebo capsules or matching suspension
Subjects are enrolled in successive cohorts and are randomized to receive either EDP-788 or placebo capsules. If the safety profile of the drug is acceptable, based upon review of blinded data, the cohort receiving the next higher dose will be treated. Up to 8 cohorts will be recruited. All subjects receive a single dose of study drug (EDP-788 or placebo).
Subjects in Cohort C will receive a second single dose of study drug (EDP-788 or placebo) approximately 2 weeks after the first dose. The second dose will be administered as a liquid suspension rather than as a capsule formulation. The purpose of the second dose is to estimate the bioavailability of the capsule formulation relative to the suspension.
Subjects in Cohort E will receive a second single dose of study drug (EDP-788 or placebo) approximately 2 weeks after the first does. The second dose will be administered with a standard test meal. The purpose of the second dose is to estimate the effect of food on absorption of EDP-788.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01999725
|United States, Texas|
|PPD Phase I Clinic|
|Austin, Texas, United States, 78744|
|Principal Investigator:||Theresa T Pham, MD||PPD Phase I Clinic|