A Multiple Dose Study of the Safety, Tolerability and PK of CMX157 in Healthy Subjects
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ClinicalTrials.gov Identifier: NCT02585440 |
Recruitment Status :
Completed
First Posted : October 23, 2015
Last Update Posted : February 2, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infectious Disease | Drug: CMX157 Drug: placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
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 Start Date : | April 2016 |
Actual Primary Completion Date : | August 2016 |
Actual Study Completion Date : | September 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: Group A
CMX157, tablet, 5 mg, QD, 14 days versus CMX157 placebo, 5 mg, tablet, QD, 14 days
|
Drug: CMX157
Oral tablet
Other Name: Lipid Conjugate TFV Drug: placebo Oral tablet |
Experimental: Group B
CMX157, tablet, 10 mg, QD, 14 days versus CMX157, placebo tablet, 10 mg, QD, 14 days
|
Drug: CMX157
Oral tablet
Other Name: Lipid Conjugate TFV Drug: placebo Oral tablet |
Experimental: Group C
CMX157, tablet, 25 mg, QD, 14 days versus placebo CMX157, placebo tablet, 25 mg, QD, 14 days
|
Drug: CMX157
Oral tablet
Other Name: Lipid Conjugate TFV Drug: placebo Oral tablet |
Experimental: Group D
CMX157, tablet, 50 mg, QD, 14 days versus CMX157, placebo tablet, 50 mg, QD, 14 days
|
Drug: CMX157
Oral tablet
Other Name: Lipid Conjugate TFV Drug: placebo Oral tablet |
Experimental: Group E
CMX157, tablet, 100 mg, QD, 14 days versus CMX157, placebo tablet, 100 mg, QD, 14 days
|
Drug: CMX157
Oral tablet
Other Name: Lipid Conjugate TFV Drug: placebo Oral tablet |
- Evaluation of the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels. [ Time Frame: 28 days ]Capture adverse events, physical examinations, ECGs and clinical laboratory panels.
- Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state. [ Time Frame: 28 days ]Measuring Cmax: the peak plasma concentration.
- Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state. [ Time Frame: 28 days ]Measuring Cmax: the peak plasma concentration.
- Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state. [ Time Frame: 28 days ]Measuring Tmax: the time Cmax was observed.
- Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state. [ Time Frame: 28 days ]Measuring Tmax: the time Cmax was observed.
- Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state. [ Time Frame: 28 days ]Measuring AUC: area under the plasma concentration versus time curve.
- Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state. [ Time Frame: 28 days ]Measuring AUC: area under the plasma concentration versus time curve.
- Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state. [ Time Frame: 28 days ]Measuring Cmin: minimum observed plasma concentration.
- Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state. [ Time Frame: 28 days ]Measuring Cmin: minimum observed plasma concentration.

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585440
Thailand | |
Bangkok, Thailand |
Study Chair: | John Sullivan-Bolyai, MD, MPH | ContraVir |
Responsible Party: | ContraVir Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT02585440 |
Other Study ID Numbers: |
CTRV-CMX-102 |
First Posted: | October 23, 2015 Key Record Dates |
Last Update Posted: | February 2, 2017 |
Last Verified: | December 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Communicable Diseases Infection |