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

ContraVir Pharmaceuticals, Inc.50 enrolled

Overview

This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Infectious Disease

Interventions

CMX157DRUG

Oral tablet

placeboDRUG

Oral tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Bangkok, Thailand

Outcomes

Primary Outcomes

Evaluation of the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.

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

Time frame: 28 days

Secondary Outcomes

Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.

Measuring Cmax: the peak plasma concentration.

Time frame: 28 days

Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.

Measuring Cmax: the peak plasma concentration.

Time frame: 28 days

Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.

Measuring Tmax: the time Cmax was observed.

Time frame: 28 days

Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.

Measuring Tmax: the time Cmax was observed.

Time frame: 28 days

Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.

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

Time frame: 28 days

Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.

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

Time frame: 28 days

Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.