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CompletedNCT02710604Updated Sep 13, 2017

Phase 2, Multiple Ascending Dose Proof of Concept Study

A Phase 2 interventional study of CMX157 and TDF in Infectious Disease, sponsored by ContraVir Pharmaceuticals, Inc.. Completed at 1 site in Thailand. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-09-13.

Sponsored by ContraVir Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.

Read the 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.

02

Conditions studied

  • Infectious Disease

Keywords

  • chronic hepatitis B(CHB)
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Active comparator
    CMX157 5mg versus TDF

    CMX157, 5mg tablet, 28 days versus TDF(tenofovir disoproxil fumerate) 300mg tablet, 28 days

    Drug: CMX157 · Drug: TDF

  • Active comparator
    CMX157 10mg versus TDF

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

    Drug: CMX157 · Drug: TDF

  • Active comparator
    CMX157 25mg versus TDF

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

    Drug: CMX157 · Drug: TDF

  • Active comparator
    CMX157 50mg versus TDF

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

    Drug: CMX157 · Drug: TDF

  • Active comparator
    CMX157 100mg versus TDF

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

    Drug: CMX157 · Drug: TDF

Interventions

  • DrugCMX157

    tablet

    Also known as: lipid conjugate TFV(tenofovir)

  • DrugTDF

    300mg tablet

    Also known as: tenofovir disoproxil fumerate

05

What researchers measure

Primary outcomes

  1. Evaluation of the safety and tolerability of increasing multiple oral doses of CMX157 in HBV + patients

    Capture adverse events, physical examinations, ECGs and clinical laboratory panels

    Time frame: 28 days

  2. To evaluate the antiviral activity of CMX157 versus tenofovir disproxil fumarate(TDF).

    HBV DNA levels

    Time frame: 28 days

Secondary outcomes

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

    Measuring Cmax(concentration maximum): the peak plasma concentration.

    Time frame: 28 days

  2. Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Tmax.

    Measuring Tmax(time maximum): the time Cmax was observed.

    Time frame: 28 days

  3. Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: AUC.

    Measuring AUC(area under the curve): area under plasma concentration versus time curve.

    Time frame: 28 days

  4. Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Cmin.

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

    Time frame: 28 days

06

Study locations

1 site
  • Bangkok, Thailand
07

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT02710604
Lead sponsor
ContraVir Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Mar 17, 2016
Start date
May 2016
Primary completion
Jul 18, 2017
Completion
Jul 18, 2017
Last update
Sep 13, 2017

Study contacts

John Sullivan-Boylai, MD
study chair · ContraVir Pharmaceuticals, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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