Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Enanta Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01999725
First received: November 25, 2013
Last updated: January 7, 2015
Last verified: January 2015
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Pharmacokinetic parameters [ Time Frame: From time of dosing to 3 days after receiving study drug ] [ Designated as safety issue: No ]
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)
Genders Eligible for Study:   Both
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
Health Authority: United States: Food and Drug Administration

Keywords provided by Enanta Pharmaceuticals:
Normal Volunteers, Safety, Pharmacokinetics

ClinicalTrials.gov processed this record on September 29, 2016