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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Enanta Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Enanta Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01999725
First received: November 25, 2013
Last updated: July 21, 2014
Last verified: November 2013

November 25, 2013
July 21, 2014
January 2014
September 2014   (final data collection date for primary outcome measure)
Incidence and severity of adverse events [ Time Frame: From time of dosing to 8 - 10 days after receiving study drug ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01999725 on ClinicalTrials.gov Archive Site
Changes from baseline in laboratory values and vital signs [ Time Frame: From time of dosing to 8 - 10 days after receiving study drug ] [ Designated as safety issue: Yes ]
Same as current
Pharmacokinetic parameters [ Time Frame: From time of dosing to 3 days after receiving study drug ] [ Designated as safety issue: No ]
Same as current
 
Evaluation of the Safety and Pharmacokinetics of a Single Oral Dose of EDP-788
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Safety, Tolerability, and Pharmacokinetic Study of EDP-788 in Healthy Adult Volunteers

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Safety in Normal Volunteers
  • Drug: EDP-788
    EDP-788 Capsules and matching placebo capsules. EDP-788 Liquid Suspension and matching placebo. All interventions are given as single doses
  • Drug: Placebo
    Matching placebo capsules or matching suspension
  • Experimental: EDP-788
    Single doses with dose escalation to continue in successive cohorts
    Intervention: Drug: EDP-788
  • Placebo Comparator: Placebo
    Single dose with matching placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
64
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact: Dane R Eckols 512-447-2985 Dane.Eckols@ppdi.com
United States
 
NCT01999725
EDP788-001
Yes
Enanta Pharmaceuticals
Enanta Pharmaceuticals
Not Provided
Principal Investigator: Theresa T Pham, MD PPD Phase I Clinic
Enanta Pharmaceuticals
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP