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

ContraVir Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Infectious Disease

Treatments: Drug: placebo; Drug: CMX157

Study type: Interventional

Funder types: Industry

Identifiers

NCT02585440

CTRV-CMX-102

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 5 patient groups

Group A

Experimental group

Description:

CMX157, tablet, 5 mg, QD, 14 days versus CMX157 placebo, 5 mg, tablet, QD, 14 days

Treatment:

Drug: CMX157

Drug: placebo

Group B

Experimental group

Description:

CMX157, tablet, 10 mg, QD, 14 days versus CMX157, placebo tablet, 10 mg, QD, 14 days

Treatment:

Drug: CMX157

Drug: placebo

Group C

Experimental group

Description:

CMX157, tablet, 25 mg, QD, 14 days versus placebo CMX157, placebo tablet, 25 mg, QD, 14 days

Treatment:

Drug: CMX157

Drug: placebo

Group D

Experimental group

Description:

CMX157, tablet, 50 mg, QD, 14 days versus CMX157, placebo tablet, 50 mg, QD, 14 days

Treatment:

Drug: CMX157

Drug: placebo

Group E

Experimental group

Description:

CMX157, tablet, 100 mg, QD, 14 days versus CMX157, placebo tablet, 100 mg, QD, 14 days

Treatment:

Drug: CMX157

Drug: placebo