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

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

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

Study Overview

• Status: Completed
• Conditions: Infectious Disease
• Intervention / Treatment: Drug: CMX157; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; CMX157, tablet, 5 mg, QD, 14 days versus CMX157 placebo, 5 mg, tablet, QD, 14 days	Drug: CMX157; Oral tablet; Other Names: Lipid Conjugate TFV; Drug: placebo; Oral tablet
Experimental: Group B; CMX157, tablet, 10 mg, QD, 14 days versus CMX157, placebo tablet, 10 mg, QD, 14 days	Drug: CMX157; Oral tablet; Other Names: Lipid Conjugate TFV; Drug: placebo; Oral tablet
Experimental: Group C; CMX157, tablet, 25 mg, QD, 14 days versus placebo CMX157, placebo tablet, 25 mg, QD, 14 days	Drug: CMX157; Oral tablet; Other Names: Lipid Conjugate TFV; Drug: placebo; Oral tablet
Experimental: Group D; CMX157, tablet, 50 mg, QD, 14 days versus CMX157, placebo tablet, 50 mg, QD, 14 days	Drug: CMX157; Oral tablet; Other Names: Lipid Conjugate TFV; Drug: placebo; Oral tablet
Experimental: Group E; CMX157, tablet, 100 mg, QD, 14 days versus CMX157, placebo tablet, 100 mg, QD, 14 days	Drug: CMX157; Oral tablet; Other Names: Lipid Conjugate TFV; Drug: placebo; Oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.	Measuring Cmax: the peak plasma concentration.	28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.	Measuring Cmax: the peak plasma concentration.	28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.	Measuring Tmax: the time Cmax was observed.	28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.	Measuring Tmax: the time Cmax was observed.	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.	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.	28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.	Measuring Cmin: minimum observed plasma concentration.	28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.	Measuring Cmin: minimum observed plasma concentration.	28 days

Collaborators and Investigators

• Sponsor: ContraVir Pharmaceuticals, Inc.
• Investigators: Study Chair: John Sullivan-Bolyai, MD, MPH, ContraVir

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimate): October 23, 2015

Study Record Updates

• Last Update Posted (Estimate): February 2, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Hexadecyloxypropyl 9-(2-(phosphonomethoxy)propyl)adenine
• Other Study ID Numbers: CTRV-CMX-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES