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

Primary Purpose

Infectious Disease

Status
Completed
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
CMX157
placebo
Sponsored by
ContraVir Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infectious Disease

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Group D

Group E

Arm Description

CMX157, tablet, 5 mg, QD, 14 days versus CMX157 placebo, 5 mg, tablet, QD, 14 days

CMX157, tablet, 10 mg, QD, 14 days versus CMX157, placebo tablet, 10 mg, QD, 14 days

CMX157, tablet, 25 mg, QD, 14 days versus placebo CMX157, placebo tablet, 25 mg, QD, 14 days

CMX157, tablet, 50 mg, QD, 14 days versus CMX157, placebo tablet, 50 mg, QD, 14 days

CMX157, tablet, 100 mg, QD, 14 days versus CMX157, placebo tablet, 100 mg, QD, 14 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
Measuring Cmax: the peak plasma concentration.
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Measuring Cmax: the peak plasma concentration.
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
Measuring Tmax: the time Cmax was observed.
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Measuring Tmax: the time Cmax was observed.
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
Measuring AUC: area under the plasma concentration versus time curve.
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Measuring AUC: area under the plasma concentration versus time curve.
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
Measuring Cmin: minimum observed plasma concentration.
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Measuring Cmin: minimum observed plasma concentration.

Full Information

First Posted
September 30, 2015
Last Updated
January 31, 2017
Sponsor
ContraVir Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02585440
Brief Title
A Multiple Dose Study of the Safety, Tolerability and PK of CMX157 in Healthy Subjects
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ContraVir Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
CMX157, tablet, 5 mg, QD, 14 days versus CMX157 placebo, 5 mg, tablet, QD, 14 days
Arm Title
Group B
Arm Type
Experimental
Arm Description
CMX157, tablet, 10 mg, QD, 14 days versus CMX157, placebo tablet, 10 mg, QD, 14 days
Arm Title
Group C
Arm Type
Experimental
Arm Description
CMX157, tablet, 25 mg, QD, 14 days versus placebo CMX157, placebo tablet, 25 mg, QD, 14 days
Arm Title
Group D
Arm Type
Experimental
Arm Description
CMX157, tablet, 50 mg, QD, 14 days versus CMX157, placebo tablet, 50 mg, QD, 14 days
Arm Title
Group E
Arm Type
Experimental
Arm Description
CMX157, tablet, 100 mg, QD, 14 days versus CMX157, placebo tablet, 100 mg, QD, 14 days
Intervention Type
Drug
Intervention Name(s)
CMX157
Other Intervention Name(s)
Lipid Conjugate TFV
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Oral tablet
Primary Outcome Measure Information:
Title
Evaluation of the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.
Description
Capture adverse events, physical examinations, ECGs and clinical laboratory panels.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
Description
Measuring Cmax: the peak plasma concentration.
Time Frame
28 days
Title
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Description
Measuring Cmax: the peak plasma concentration.
Time Frame
28 days
Title
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
Description
Measuring Tmax: the time Cmax was observed.
Time Frame
28 days
Title
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Description
Measuring Tmax: the time Cmax was observed.
Time Frame
28 days
Title
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
Description
Measuring AUC: area under the plasma concentration versus time curve.
Time Frame
28 days
Title
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Description
Measuring AUC: area under the plasma concentration versus time curve.
Time Frame
28 days
Title
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
Description
Measuring Cmin: minimum observed plasma concentration.
Time Frame
28 days
Title
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Description
Measuring Cmin: minimum observed plasma concentration.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Sullivan-Bolyai, MD, MPH
Organizational Affiliation
ContraVir
Official's Role
Study Chair
Facility Information:
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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