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

NCT ID: NCT02585440

Last Updated: 2017-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Infectious Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

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

Group Type EXPERIMENTAL

CMX157

Intervention Type DRUG

Oral tablet

placebo

Intervention Type DRUG

Oral tablet

Group B

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

Group Type EXPERIMENTAL

CMX157

Intervention Type DRUG

Oral tablet

placebo

Intervention Type DRUG

Oral tablet

Group C

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

Group Type EXPERIMENTAL

CMX157

Intervention Type DRUG

Oral tablet

placebo

Intervention Type DRUG

Oral tablet

Group D

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

Group Type EXPERIMENTAL

CMX157

Intervention Type DRUG

Oral tablet

placebo

Intervention Type DRUG

Oral tablet

Group E

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

Group Type EXPERIMENTAL

CMX157

Intervention Type DRUG

Oral tablet

placebo

Intervention Type DRUG

Oral tablet

Interventions

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CMX157

Oral tablet

Intervention Type DRUG

placebo

Oral tablet

Intervention Type DRUG

Other Intervention Names

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Lipid Conjugate TFV

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ContraVir Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Sullivan-Bolyai, MD, MPH

Role: STUDY_CHAIR

ContraVir

Locations

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Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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CTRV-CMX-102

Identifier Type: -

Identifier Source: org_study_id

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