Evaluation of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of EDP-788

Sponsor

Enanta Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT02255968

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: EDP-788 Drug: Placebo	Phase 1

Detailed Description

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Safety, Tolerability, and Pharmacokinetic Study of EDP-788 in Healthy Adult Volunteers

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EDP-788 Multiple doses with dose escalation to continue in successive cohorts	Drug: EDP-788 EDP-788 Capsules. All interventions are given as multiple doses.
Placebo Comparator: Placebo Multiple doses with dose escalation to continue in successive cohorts	Drug: Placebo Matching placebo capsules. All interventions are given as multiple doses

Arm

Intervention/Treatment

Experimental: EDP-788

Multiple doses with dose escalation to continue in successive cohorts

Drug: EDP-788

EDP-788 Capsules. All interventions are given as multiple doses.

Placebo Comparator: Placebo

Multiple doses with dose escalation to continue in successive cohorts

Drug: Placebo

Matching placebo capsules. All interventions are given as multiple doses

Outcome Measures

Primary Outcome Measures

Incidence and severity of adverse events [From time of dosing to 20-23 days after receiving last dose of study drug]

Secondary Outcome Measures

Changes from baseline in laboratory values and vital signs [From time of dosing to 20-23 days after receiving last dose of study drug]
Pharmacokinetic parameters [From time of dosing to 3 days after receiving the last dose of study drug]
As measured by peak plasma concentration (Cmax)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD Phase 1 Clinic	Austin	Texas	United States	78744

Sponsors and Collaborators

Enanta Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Enanta Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT02255968

Other Study ID Numbers:

EDP788-002

First Posted:

Oct 3, 2014

Last Update Posted:

May 12, 2015

Last Verified:

May 1, 2015

Keywords provided by Enanta Pharmaceuticals

Normal Volunteers

Safety

Pharmacokinetics

Study Results

No Results Posted as of May 12, 2015