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Completed

NCT Number: NCT02585440

A Multiple Dose Study of the Safety, Tolerability and PK of CMX157 in Healthy Subjects

This is a phase 1 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 Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bangkok, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

CMX157

Drug

Oral tablet

Other names: Lipid Conjugate TFV

Placebo

Drug

Oral tablet

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

ContraVir Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 23, 2015
Registry last updated
Feb 2, 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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