A Multiple Dose Study of the Safety, Tolerability and PK of CMX157 in Healthy Subjects
A Phase 1, Randomized, Partial-Blind, Placebo-controlled, Sequential Dose Group, Ascending, Multiple Dose Study of the Safety, Tolerability and Pharmacokinetics, With Food Effect, of CMX157 in Healthy Subjects
1 other identifier
interventional
50
1 country
1
Brief Summary
This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2016
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2015
CompletedFirst Posted
Study publicly available on registry
October 23, 2015
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedFebruary 2, 2017
December 1, 2016
4 months
September 30, 2015
January 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.
Capture adverse events, physical examinations, ECGs and clinical laboratory panels.
28 days
Secondary Outcomes (8)
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
28 days
- +3 more secondary outcomes
Study Arms (5)
Group A
EXPERIMENTALCMX157, tablet, 5 mg, QD, 14 days versus CMX157 placebo, 5 mg, tablet, QD, 14 days
Group B
EXPERIMENTALCMX157, tablet, 10 mg, QD, 14 days versus CMX157, placebo tablet, 10 mg, QD, 14 days
Group C
EXPERIMENTALCMX157, tablet, 25 mg, QD, 14 days versus placebo CMX157, placebo tablet, 25 mg, QD, 14 days
Group D
EXPERIMENTALCMX157, tablet, 50 mg, QD, 14 days versus CMX157, placebo tablet, 50 mg, QD, 14 days
Group E
EXPERIMENTALCMX157, tablet, 100 mg, QD, 14 days versus CMX157, placebo tablet, 100 mg, QD, 14 days
Interventions
Eligibility Criteria
You may qualify if:
- Age: 18-55.
- Capable of giving written informed consent.
- Capable of completing study requirements.
You may not qualify if:
- Positive result for HIV, HBV, or HCV.
- History or medical condition which could impact patient safety.
- Current or past abuse of alcohol or illicit drugs.
- Participation in another clinical trial within the past 30 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Bangkok, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
John Sullivan-Bolyai, MD, MPH
ContraVir
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2015
First Posted
October 23, 2015
Study Start
April 1, 2016
Primary Completion
August 1, 2016
Study Completion
September 1, 2016
Last Updated
February 2, 2017
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will share