CompletedNCT02585440Updated Feb 2, 2017

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

A Phase 1 interventional study of CMX157 and placebo in Infectious Disease, sponsored by ContraVir Pharmaceuticals, Inc.. Completed at 1 site in Thailand. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-02.

Sponsored by ContraVir Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 50
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

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

Read the detailed 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.

Conditions studied

Infectious Disease

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Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Age: 18-55.
Capable of giving written informed consent.
Capable of completing study requirements.

Exclusion criteria

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 50 participants (actual)

Study arms

Experimental
Group A
CMX157, tablet, 5 mg, QD, 14 days versus CMX157 placebo, 5 mg, tablet, QD, 14 days
Drug: CMX157 · Drug: placebo
Experimental
Group B
CMX157, tablet, 10 mg, QD, 14 days versus CMX157, placebo tablet, 10 mg, QD, 14 days
Drug: CMX157 · Drug: placebo
Experimental
Group C
CMX157, tablet, 25 mg, QD, 14 days versus placebo CMX157, placebo tablet, 25 mg, QD, 14 days
Drug: CMX157 · Drug: placebo
Experimental
Group D
CMX157, tablet, 50 mg, QD, 14 days versus CMX157, placebo tablet, 50 mg, QD, 14 days
Drug: CMX157 · Drug: placebo
Experimental
Group E
CMX157, tablet, 100 mg, QD, 14 days versus CMX157, placebo tablet, 100 mg, QD, 14 days
Drug: CMX157 · Drug: placebo

Interventions

DrugCMX157
Oral tablet
Also known as: Lipid Conjugate TFV
Drugplacebo
Oral tablet

What researchers measure

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.
Measuring Cmin: minimum observed plasma concentration.
Time frame: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
Measuring Cmin: minimum observed plasma concentration.
Time frame: 28 days

Study locations

1 site

Bangkok, Thailand

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT02585440
Lead sponsor: ContraVir Pharmaceuticals, Inc.
Responsible party: Sponsor
First posted: Oct 23, 2015
Start date: Apr 2016
Primary completion: Aug 2016
Completion: Sep 2016
Last update: Feb 2, 2017

Study contacts

John Sullivan-Bolyai, MD, MPH

study chair · ContraVir

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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