Evaluation of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of EDP-788
A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Safety, Tolerability, and Pharmacokinetic Study of EDP-788 in Healthy Adult Volunteers
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Aug 2014
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 3, 2014
CompletedMay 12, 2015
May 1, 2015
2 months
July 29, 2014
May 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and severity of adverse events
From time of dosing to 20-23 days after receiving last dose of study drug
Secondary Outcomes (2)
Changes from baseline in laboratory values and vital signs
From time of dosing to 20-23 days after receiving last dose of study drug
Pharmacokinetic parameters
From time of dosing to 3 days after receiving the last dose of study drug
Study Arms (2)
EDP-788
EXPERIMENTALMultiple doses with dose escalation to continue in successive cohorts
Placebo
PLACEBO COMPARATORMultiple doses with dose escalation to continue in successive cohorts
Interventions
Eligibility Criteria
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 17 - 19 day post-dosing visit
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PPD Phase 1 Clinic
Austin, Texas, 78744, United States
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
July 29, 2014
First Posted
October 3, 2014
Study Start
August 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
May 12, 2015
Record last verified: 2015-05