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

• ClinicalTrials.gov Identifier: NCT01999725
• Recruitment Status: Completed
• First Posted: December 3, 2013
• Last Update Posted: January 9, 2015
• Sponsor: Enanta Pharmaceuticals
• Information provided by (Responsible Party): Enanta Pharmaceuticals

Study Description

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

Condition or disease	Intervention/treatment	Phase
Safety in Normal Volunteers	Drug: EDP-788; Drug: Placebo	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 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 One-Day (Single and Divided Dose) Safety, Tolerability, and Pharmacokinetic Study of EDP-788 in Healthy Adult Volunteers
• Study Start Date: January 2014
• Actual Primary Completion Date: September 2014
• Actual Study Completion Date: September 2014

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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:

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

Eligibility Criteria

• 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

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
• Other Study ID Numbers: EDP788-001
• First Posted: December 3, 2013
• Last Update Posted: January 9, 2015
• Last Verified: January 2015

Keywords provided by Enanta Pharmaceuticals:

Normal Volunteers, Safety, Pharmacokinetics