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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
Sponsor:
Information provided by (Responsible Party):
ContraVir Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Infectious Disease Drug: CMX157 Drug: placebo Phase 1

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 Design
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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
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state. [ Time Frame: 28 days ]
    Measuring Cmax: the peak plasma concentration.

  2. Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state. [ Time Frame: 28 days ]
    Measuring Cmax: the peak plasma concentration.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state. [ Time Frame: 28 days ]
    Measuring Cmin: minimum observed plasma concentration.

  8. Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state. [ Time Frame: 28 days ]
    Measuring Cmin: minimum observed plasma concentration.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
Thailand
Bangkok, Thailand
Sponsors and Collaborators
ContraVir Pharmaceuticals, Inc.
Investigators
Study Chair: John Sullivan-Bolyai, MD, MPH ContraVir Pharmaceuticals, Inc.
More Information
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Responsible Party: ContraVir Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02585440     History of Changes
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

Additional relevant MeSH terms:
Communicable Diseases
Infection