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Phase 2, Multiple Ascending Dose Proof of Concept Study

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ClinicalTrials.gov Identifier: NCT02710604
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
ContraVir Pharmaceuticals, Inc.

Brief Summary:
This is a phase 2a 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: TDF Phase 2

Detailed Description:
This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels in hepatitis B virus(HBV) infected subjects.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Open-label, Ascending, Sequential Dose Group, Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of CMX157 in HBV-infected Subjects
Study Start Date : May 2016
Actual Primary Completion Date : July 18, 2017
Actual Study Completion Date : July 18, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Tenofovir

Arm Intervention/treatment
Active Comparator: CMX157 5mg versus TDF
CMX157, 5mg tablet, 28 days versus TDF(tenofovir disoproxil fumerate) 300mg tablet, 28 days
Drug: CMX157
tablet
Other Name: lipid conjugate TFV(tenofovir)

Drug: TDF
300mg tablet
Other Name: tenofovir disoproxil fumerate

Active Comparator: CMX157 10mg versus TDF
CMX157, 10mg tablet, 28 days versus TDF 300mg tablet, 28 days
Drug: CMX157
tablet
Other Name: lipid conjugate TFV(tenofovir)

Drug: TDF
300mg tablet
Other Name: tenofovir disoproxil fumerate

Active Comparator: CMX157 25mg versus TDF
CMX157, 25mg tablet, 28 days versus TDF 300mg tablet, 28 days
Drug: CMX157
tablet
Other Name: lipid conjugate TFV(tenofovir)

Drug: TDF
300mg tablet
Other Name: tenofovir disoproxil fumerate

Active Comparator: CMX157 50mg versus TDF
CMX157, 50mg tablet, 28 days versus TDF 300mg tablet, 28 days
Drug: CMX157
tablet
Other Name: lipid conjugate TFV(tenofovir)

Drug: TDF
300mg tablet
Other Name: tenofovir disoproxil fumerate

Active Comparator: CMX157 100mg versus TDF
CMX157, 100mg tablet, 28 days versus TDF 300mg tablet, 28 days
Drug: CMX157
tablet
Other Name: lipid conjugate TFV(tenofovir)

Drug: TDF
300mg tablet
Other Name: tenofovir disoproxil fumerate




Primary Outcome Measures :
  1. Evaluation of the safety and tolerability of increasing multiple oral doses of CMX157 in HBV + patients [ Time Frame: 28 days ]
    Capture adverse events, physical examinations, ECGs and clinical laboratory panels

  2. To evaluate the antiviral activity of CMX157 versus tenofovir disproxil fumarate(TDF). [ Time Frame: 28 days ]
    HBV DNA levels


Secondary Outcome Measures :
  1. Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects, Cmax. [ Time Frame: 28 days ]
    Measuring Cmax(concentration maximum): the peak plasma concentration.

  2. Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Tmax. [ Time Frame: 28 days ]
    Measuring Tmax(time maximum): the time Cmax was observed.

  3. Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: AUC. [ Time Frame: 28 days ]
    Measuring AUC(area under the curve): area under plasma concentration versus time curve.

  4. Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Cmin. [ Time Frame: 28 days ]
    Measuring Cmin(concentration minimum): minimum observed plasma concentration.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Capable of giving written informed consent.
  • Capable of completing study requirements.
  • Chronic hepatitis B positive.
  • HBV treatment naïve.

Exclusion Criteria:

  • Positive result for HCV(hepatitis C virus), HDV(hepatitis D virus) or HIV(human immunodeficiency virus).
  • History or medical condition that could impact patient safety.
  • Current or past abuse of alcohol or illicit drugs.
  • Abnormal laboratory value or ECG.
  • Pregnant or breastfeeding.
  • Clinical, histologic or laboratory evidence of significant liver fibrosis or cirrhosis.
  • Systemic immunosuppression.
  • Received an investigational drug or investigational vaccine within the 90 days prior to the first dose of study drug.

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): NCT02710604


Locations
Thailand
Bangkok, Thailand
Sponsors and Collaborators
ContraVir Pharmaceuticals, Inc.
Investigators
Study Chair: John Sullivan-Boylai, MD ContraVir Pharmaceuticals, Inc.

Responsible Party: ContraVir Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02710604     History of Changes
Other Study ID Numbers: CTRV-CMX157-201
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by ContraVir Pharmaceuticals, Inc.:
chronic hepatitis B(CHB)

Additional relevant MeSH terms:
Communicable Diseases
Infection
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents