Clinical trial NCT01999725: Evaluation of the Safety and Pharmacokinetics of a Single Oral Dose of EDP-788
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety in Normal Volunteers
Keywords: Normal Volunteers, Safety, Pharmacokinetics
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2013-12-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Incidence and severity of adverse events
timeFrame: From time of dosing to 8 - 10 days after receiving study drug
Secondary outcomes:
measure: Changes from baseline in laboratory values and vital signs
timeFrame: From time of dosing to 8 - 10 days after receiving study drug
Other outcomes:
measure: Pharmacokinetic parameters
timeFrame: From time of dosing to 3 days after receiving study drug
Locations:
city: Austin
country: United States
facility: PPD Phase I Clinic
state: Texas
Study officials:
affiliation: PPD Phase I Clinic
name: Theresa T Pham, MD
role: PRINCIPAL_INVESTIGATOR
References: