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Phase 2, Multiple Ascending Dose Proof of Concept Study

Sponsor
ContraVir Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02710604
Collaborator
(none)
62
Enrollment
1
Location
5
Arms
14.6
Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
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 1, 2016
Actual Primary Completion Date :
Jul 18, 2017
Actual Study Completion Date :
Jul 18, 2017

Arms and Interventions

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 Names:
  • lipid conjugate TFV(tenofovir)

    • Drug: TDF
    300mg tablet
    Other Names:
  • tenofovir disoproxil fumerate

    		•
    Active Comparator: CMX157 10mg versus TDF

    CMX157, 10mg tablet, 28 days versus TDF 300mg tablet, 28 days

    Drug: CMX157
    tablet
    Other Names:
  • lipid conjugate TFV(tenofovir)

    • Drug: TDF
    300mg tablet
    Other Names:
  • tenofovir disoproxil fumerate

    		•
    Active Comparator: CMX157 25mg versus TDF

    CMX157, 25mg tablet, 28 days versus TDF 300mg tablet, 28 days

    Drug: CMX157
    tablet
    Other Names:
  • lipid conjugate TFV(tenofovir)

    • Drug: TDF
    300mg tablet
    Other Names:
  • tenofovir disoproxil fumerate

    		•
    Active Comparator: CMX157 50mg versus TDF

    CMX157, 50mg tablet, 28 days versus TDF 300mg tablet, 28 days

    Drug: CMX157
    tablet
    Other Names:
  • lipid conjugate TFV(tenofovir)

    • Drug: TDF
    300mg tablet
    Other Names:
  • tenofovir disoproxil fumerate

    		•
    Active Comparator: CMX157 100mg versus TDF

    CMX157, 100mg tablet, 28 days versus TDF 300mg tablet, 28 days

    Drug: CMX157
    tablet
    Other Names:
  • lipid conjugate TFV(tenofovir)

    • Drug: TDF
    300mg tablet
    Other Names:
  • tenofovir disoproxil fumerate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of the safety and tolerability of increasing multiple oral doses of CMX157 in HBV + patients [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). [28 days]

      HBV DNA levels

    Secondary Outcome Measures

    1. Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects, Cmax. [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. [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. [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. [28 days]

      Measuring Cmin(concentration minimum): minimum observed plasma concentration.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bangkok Thailand

    Sponsors and Collaborators

    • ContraVir Pharmaceuticals, Inc.

    Investigators

    • Study Chair: John Sullivan-Boylai, MD, ContraVir Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ContraVir Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT02710604
    Other Study ID Numbers:
    • CTRV-CMX157-201
    First Posted:
    Mar 17, 2016
    Last Update Posted:
    Sep 13, 2017
    Last Verified:
    Dec 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by ContraVir Pharmaceuticals, Inc.
    chronic hepatitis B(CHB)
    Additional relevant MeSH terms:
    Communicable Diseases
    Infections
    Tenofovir
    Hexadecyloxypropyl 9-(2-(phosphonomethoxy)propyl)adenine

    Study Results

    No Results Posted as of Sep 13, 2017