A Multiple Dose Study of the Safety, Tolerability and PK of CMX157 in Healthy Subjects

Phase 1

Completed

• Conditions: Infectious Disease
• Interventions: Drug: CMX157; Drug: placebo

• Registration Number: NCT02585440
• Lead Sponsor: ContraVir Pharmaceuticals, Inc.

Brief Summary

This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.

Detailed Description

This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels, in a fasted state and a fed state.

Study Timeline

• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-23
• Study Start: 2016-04
• Primary Completion: 2016-08
• Study Completion: 2016-09
• Status Verified: 2016-12
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age: 18-55.
• Capable of giving written informed consent.
• Capable of completing study requirements.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	CMX157	CMX157, tablet, 5 mg, QD, 14 days versus CMX157 placebo, 5 mg, tablet, QD, 14 days
Group A	placebo	CMX157, tablet, 5 mg, QD, 14 days versus CMX157 placebo, 5 mg, tablet, QD, 14 days
Group B	CMX157	CMX157, tablet, 10 mg, QD, 14 days versus CMX157, placebo tablet, 10 mg, QD, 14 days
Group B	placebo	CMX157, tablet, 10 mg, QD, 14 days versus CMX157, placebo tablet, 10 mg, QD, 14 days
Group C	placebo	CMX157, tablet, 25 mg, QD, 14 days versus placebo CMX157, placebo tablet, 25 mg, QD, 14 days
Group D	CMX157	CMX157, tablet, 50 mg, QD, 14 days versus CMX157, placebo tablet, 50 mg, QD, 14 days
Group D	placebo	CMX157, tablet, 50 mg, QD, 14 days versus CMX157, placebo tablet, 50 mg, QD, 14 days
Group E	CMX157	CMX157, tablet, 100 mg, QD, 14 days versus CMX157, placebo tablet, 100 mg, QD, 14 days
Group E	placebo	CMX157, tablet, 100 mg, QD, 14 days versus CMX157, placebo tablet, 100 mg, QD, 14 days
Group C	CMX157	CMX157, tablet, 25 mg, QD, 14 days versus placebo CMX157, placebo tablet, 25 mg, QD, 14 days

Primary Outcome Measures

Name	Time	Method
Evaluation of the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.	28 days	Capture adverse events, physical examinations, ECGs and clinical laboratory panels.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.	28 days	Measuring Cmin: minimum observed plasma concentration.
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.	28 days	Measuring Cmin: minimum observed plasma concentration.