Healthy Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Safety, Tolerability, and Pharmacokinetic Study of EDP-788 in Healthy Adult Volunteers
Verified date | May 2015 |
Source | Enanta Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 16 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | PPD Phase 1 Clinic | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
Enanta Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and severity of adverse events | From time of dosing to 20-23 days after receiving last dose of study drug | Yes | |
Secondary | Changes from baseline in laboratory values and vital signs | From time of dosing to 20-23 days after receiving last dose of study drug | Yes | |
Secondary | Pharmacokinetic parameters | As measured by peak plasma concentration (Cmax) | From time of dosing to 3 days after receiving the last dose of study drug | No |
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