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

NCT01999725 | Completed Phase 1 DMC

• 1 other identifier: EDP788-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Safety in Normal Volunteers

Keywords

Normal Volunteers, Safety, Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events

  From time of dosing to 8 - 10 days after receiving study drug

Secondary Outcomes (1)

• Changes from baseline in laboratory values and vital signs

  From time of dosing to 8 - 10 days after receiving study drug

Other Outcomes (1)

• Pharmacokinetic parameters

  From time of dosing to 3 days after receiving study drug

Study Arms (2)

EDP-788

EXPERIMENTAL

Single doses with dose escalation to continue in successive cohorts

Drug: EDP-788

Placebo

PLACEBO COMPARATOR

Single dose with matching placebo

Drug: Placebo

Interventions

EDP-788 DRUG

EDP-788 Capsules and matching placebo capsules. EDP-788 Liquid Suspension and matching placebo. All interventions are given as single doses

EDP-788

Placebo DRUG

Matching placebo capsules or matching suspension

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (1)

PPD Phase I Clinic

Austin, Texas, 78744, United States

Location

Study Officials

• Theresa T Pham, MD

  PPD Phase I Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 3, 2013
• Study Start: January 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 9, 2015

Record last verified: 2015-01

Locations

US (1)