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Evaluation of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of EDP-788

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255968
Recruitment Status : Terminated
First Posted : October 3, 2014
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Enanta Pharmaceuticals

Brief Summary:
The primary objective of the study is to determine the safety and tolerability of multiple 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 multiple doses of orally administered drug.

Condition or disease Intervention/treatment Phase
Healthy Drug: EDP-788 Drug: Placebo Phase 1

Detailed Description:
Three cohorts of subjects will be enrolled to receive either EDP-788 or placebo. The dose of EDP-788 will be increased with each successive cohort. In addition, a 4th cohort may be enrolled, depending on clinical findings (tolerability, safety, pharmacokinetics) observed in the first 3 cohorts. In each cohort, 8 subjects will receive a q12h oral dose regimen of EDP-788 (6 subjects) or placebo (2 subjects). All subjects receive multiple doses of study drug (EDP-788 or placebo).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 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 Multiple-Dose Safety, Tolerability, and Pharmacokinetic Study of EDP-788 in Healthy Adult Volunteers
Study Start Date : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: EDP-788
Multiple doses with dose escalation to continue in successive cohorts
Drug: EDP-788
EDP-788 Capsules. All interventions are given as multiple doses.

Placebo Comparator: Placebo
Multiple doses with dose escalation to continue in successive cohorts
Drug: Placebo
Matching placebo capsules. All interventions are given as multiple doses




Primary Outcome Measures :
  1. Incidence and severity of adverse events [ Time Frame: From time of dosing to 20-23 days after receiving last dose of study drug ]

Secondary Outcome Measures :
  1. Changes from baseline in laboratory values and vital signs [ Time Frame: From time of dosing to 20-23 days after receiving last dose of study drug ]
  2. Pharmacokinetic parameters [ Time Frame: From time of dosing to 3 days after receiving the last dose of study drug ]
    As measured by peak plasma concentration (Cmax)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 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 17 - 19 day post-dosing visit

Key Exclusion Criteria:

  • Hypersensitivity to macrolide antibiotics
  • Abnormal laboratory values
  • Gastroenteritis within 1 week of study drug administration
  • Use of any investigational drugs within 28 days of study drug administration
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255968


Locations
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United States, Texas
PPD Phase 1 Clinic
Austin, Texas, United States, 78744
Sponsors and Collaborators
Enanta Pharmaceuticals
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Responsible Party: Enanta Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02255968    
Other Study ID Numbers: EDP788-002
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Keywords provided by Enanta Pharmaceuticals:
Normal Volunteers
Safety
Pharmacokinetics