Phase 2, Multiple Ascending Dose Proof of Concept Study

Infectious Disease Clinical Trial

Official title:

A Phase 2, Randomized, Open-label, Ascending, Sequential Dose Group, Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of CMX157 in HBV-infected Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02710604
• Other study ID #: CTRV-CMX157-201
• Status: Completed
• Phase: Phase 2
• First received: March 14, 2016
• Last updated: September 12, 2017
• Start date: May 2016
• Est. completion date: July 18, 2017

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 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.

Description:

This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels in hepatitis B virus(HBV) infected subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 18, 2017
• Est. primary completion date: July 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Capable of giving written informed consent.

• Capable of completing study requirements.

• Chronic hepatitis B positive.

• HBV treatment naïve.

Exclusion Criteria:

• Positive result for HCV(hepatitis C virus), HDV(hepatitis D virus) or HIV(human immunodeficiency virus).

• History or medical condition that could impact patient safety.

• Current or past abuse of alcohol or illicit drugs.

• Abnormal laboratory value or ECG.

• Pregnant or breastfeeding.

• Clinical, histologic or laboratory evidence of significant liver fibrosis or cirrhosis.

• Systemic immunosuppression.

• Received an investigational drug or investigational vaccine within the 90 days prior to the first dose of study drug.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Disease

Intervention

Drug:
• CMX157
tablet
• TDF
300mg 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 increasing multiple oral doses of CMX157 in HBV + patients	Capture adverse events, physical examinations, ECGs and clinical laboratory panels	28 days
Primary	To evaluate the antiviral activity of CMX157 versus tenofovir disproxil fumarate(TDF).	HBV DNA levels	28 days
Secondary	Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects, Cmax.	Measuring Cmax(concentration maximum): the peak plasma concentration.	28 days
Secondary	Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Tmax.	Measuring Tmax(time maximum): the time Cmax was observed.	28 days
Secondary	Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: AUC.	Measuring AUC(area under the curve): area under plasma concentration versus time curve.	28 days
Secondary	Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Cmin.	Measuring Cmin(concentration minimum): minimum observed plasma concentration.	28 days