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

Infectious Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585440
• Other study ID #: CTRV-CMX-102
• Status: Completed
• Phase: Phase 1
• First received: September 30, 2015
• Last updated: January 31, 2017
• Start date: April 2016
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: ContraVir Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Disease

Intervention

Drug:
• CMX157
Oral tablet
• placebo
Oral tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ContraVir Pharmaceuticals, Inc.

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 days
Secondary	Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.	Measuring Cmax: the peak plasma concentration.	28 days
Secondary	Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.	Measuring Cmax: the peak plasma concentration.	28 days
Secondary	Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.	Measuring Tmax: the time Cmax was observed.	28 days
Secondary	Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.	Measuring Tmax: the time Cmax was observed.	28 days
Secondary	Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.	Measuring AUC: area under the plasma concentration versus time curve.	28 days
Secondary	Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.	Measuring AUC: area under the plasma concentration versus time curve.	28 days
Secondary	Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.	Measuring Cmin: minimum observed plasma concentration.	28 days
Secondary	Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.	Measuring Cmin: minimum observed plasma concentration.	28 days