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Completed

NCT Number: NCT02710604

Phase 2, Multiple Ascending Dose Proof of Concept Study

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

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Key information

Conditions

Infectious Disease Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bangkok, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CMX157

Drug

tablet

Other names: lipid conjugate TFV(tenofovir)

TDF

Drug

300mg tablet

Other names: tenofovir disoproxil fumerate

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

ContraVir Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2016
Registry last updated
Sep 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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