Evaluation of the Safety and Pharmacokinetics of a Single Oral Dose of EDP-788 - Full Text View

Purpose

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

Condition	Intervention	Phase
Safety in Normal Volunteers	Drug: EDP-788 Drug: Placebo	Phase 1


Study Type:	Interventional
Study Design:	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 One-Day (Single and Divided Dose) Safety, Tolerability, and Pharmacokinetic Study of EDP-788 in Healthy Adult Volunteers

Further study details as provided by Enanta Pharmaceuticals:

Primary Outcome Measures:

Incidence and severity of adverse events [ Time Frame: From time of dosing to 8 - 10 days after receiving study drug ]

Secondary Outcome Measures:

Changes from baseline in laboratory values and vital signs [ Time Frame: From time of dosing to 8 - 10 days after receiving study drug ]

Other Outcome Measures:

Pharmacokinetic parameters [ Time Frame: From time of dosing to 3 days after receiving study drug ]


Enrollment:	80
Study Start Date:	January 2014
Study Completion Date:	September 2014
Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: EDP-788 Single doses with dose escalation to continue in successive cohorts	Drug: EDP-788 EDP-788 Capsules and matching placebo capsules. EDP-788 Liquid Suspension and matching placebo. All interventions are given as single doses
Placebo Comparator: Placebo Single dose with matching placebo	Drug: Placebo Matching placebo capsules or matching suspension

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


Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01999725

Locations


United States, Texas
PPD Phase I Clinic
Austin, Texas, United States, 78744

Sponsors and Collaborators

Enanta Pharmaceuticals

Investigators


Principal Investigator:	Theresa T Pham, MD	PPD Phase I Clinic

More Information


Responsible Party:	Enanta Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01999725 History of Changes
Other Study ID Numbers:	EDP788-001
Study First Received:	November 25, 2013
Last Updated:	January 7, 2015

Keywords provided by Enanta Pharmaceuticals:


Normal Volunteers, Safety, Pharmacokinetics

ClinicalTrials.gov processed this record on September 20, 2017