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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02255968

Enrollment

Registered

2014-10-03

Start date

2014-08-31

Completion date

2014-10-31

Last updated

2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Normal Volunteers, Safety, Pharmacokinetics

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.

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).

Interventions

DRUGEDP-788

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

DRUGPlacebo

Matching placebo capsules. All interventions are given as multiple doses

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 50 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 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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026