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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02255968
• Other study ID #: EDP788-002
• Status: Terminated
• Phase: Phase 1
• First received: July 29, 2014
• Last updated: May 8, 2015
• Start date: August 2014
• Est. completion date: October 2014

Study information

• 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

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• EDP-788
EDP-788 Capsules. All interventions are given as multiple doses.
• Placebo
Matching placebo capsules. All interventions are given as multiple doses

Locations

Country	Name	City	State
United States	PPD Phase 1 Clinic	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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