Safety in Normal Volunteers
Conditions
Keywords
Normal Volunteers, Safety, Pharmacokinetics
Brief summary
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
Detailed description
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.
Interventions
DRUGEDP-788
EDP-788 Capsules and matching placebo capsules. EDP-788 Liquid Suspension and matching placebo. All interventions are given as single doses
DRUGPlacebo
Matching placebo capsules or matching suspension
Sponsors
Enanta Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
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 8 - 10 day post-dosing visit Key
Exclusion criteria
* Hypersensitivity to macrolide antibiotics * Abnormal laboratory values * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events | From time of dosing to 8 - 10 days after receiving study drug |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in laboratory values and vital signs | From time of dosing to 8 - 10 days after receiving study drug |
Other
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters | From time of dosing to 3 days after receiving study drug |
Countries
United States
Outcome results
None listed