- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02255968
Evaluation of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of EDP-788
May 8, 2015 updated by: Enanta Pharmaceuticals, Inc
A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Safety, Tolerability, and Pharmacokinetic Study of EDP-788 in Healthy Adult Volunteers
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.
Study Overview
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).
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Austin, Texas, United States, 78744
- PPD Phase 1 Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EDP-788
Multiple doses with dose escalation to continue in successive cohorts
|
EDP-788 Capsules.
All interventions are given as multiple doses.
|
Placebo Comparator: Placebo
Multiple doses with dose escalation to continue in successive cohorts
|
Matching placebo capsules.
All interventions are given as multiple doses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence and severity of adverse events
Time Frame: From time of dosing to 20-23 days after receiving last dose of study drug
|
From time of dosing to 20-23 days after receiving last dose of study drug
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From time of dosing to 20-23 days after receiving last dose of study drug
|
|
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)
|
From time of dosing to 3 days after receiving the last dose of study drug
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
July 29, 2014
First Submitted That Met QC Criteria
October 2, 2014
First Posted (Estimate)
October 3, 2014
Study Record Updates
Last Update Posted (Estimate)
May 12, 2015
Last Update Submitted That Met QC Criteria
May 8, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EDP788-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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