Phase 2, Multiple Ascending Dose Proof of Concept Study
Primary Purpose
Infectious Disease
Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
CMX157
TDF
Sponsored by
About this trial
This is an interventional treatment trial for Infectious Disease focused on measuring chronic hepatitis B(CHB)
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
CMX157 5mg versus TDF
CMX157 10mg versus TDF
CMX157 25mg versus TDF
CMX157 50mg versus TDF
CMX157 100mg versus TDF
Arm Description
CMX157, 5mg tablet, 28 days versus TDF(tenofovir disoproxil fumerate) 300mg tablet, 28 days
CMX157, 10mg tablet, 28 days versus TDF 300mg tablet, 28 days
CMX157, 25mg tablet, 28 days versus TDF 300mg tablet, 28 days
CMX157, 50mg tablet, 28 days versus TDF 300mg tablet, 28 days
CMX157, 100mg tablet, 28 days versus TDF 300mg tablet, 28 days
Outcomes
Primary Outcome Measures
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
To evaluate the antiviral activity of CMX157 versus tenofovir disproxil fumarate(TDF).
HBV DNA levels
Secondary Outcome Measures
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects, Cmax.
Measuring Cmax(concentration maximum): the peak plasma concentration.
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Tmax.
Measuring Tmax(time maximum): the time Cmax was observed.
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.
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Cmin.
Measuring Cmin(concentration minimum): minimum observed plasma concentration.
Full Information
NCT ID
NCT02710604
First Posted
March 14, 2016
Last Updated
September 12, 2017
Sponsor
ContraVir Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02710604
Brief Title
Phase 2, Multiple Ascending Dose Proof of Concept Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
July 18, 2017 (Actual)
Study Completion Date
July 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ContraVir Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Disease
Keywords
chronic hepatitis B(CHB)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CMX157 5mg versus TDF
Arm Type
Active Comparator
Arm Description
CMX157, 5mg tablet, 28 days versus TDF(tenofovir disoproxil fumerate) 300mg tablet, 28 days
Arm Title
CMX157 10mg versus TDF
Arm Type
Active Comparator
Arm Description
CMX157, 10mg tablet, 28 days versus TDF 300mg tablet, 28 days
Arm Title
CMX157 25mg versus TDF
Arm Type
Active Comparator
Arm Description
CMX157, 25mg tablet, 28 days versus TDF 300mg tablet, 28 days
Arm Title
CMX157 50mg versus TDF
Arm Type
Active Comparator
Arm Description
CMX157, 50mg tablet, 28 days versus TDF 300mg tablet, 28 days
Arm Title
CMX157 100mg versus TDF
Arm Type
Active Comparator
Arm Description
CMX157, 100mg tablet, 28 days versus TDF 300mg tablet, 28 days
Intervention Type
Drug
Intervention Name(s)
CMX157
Other Intervention Name(s)
lipid conjugate TFV(tenofovir)
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
TDF
Other Intervention Name(s)
tenofovir disoproxil fumerate
Intervention Description
300mg tablet
Primary Outcome Measure Information:
Title
Evaluation of the safety and tolerability of increasing multiple oral doses of CMX157 in HBV + patients
Description
Capture adverse events, physical examinations, ECGs and clinical laboratory panels
Time Frame
28 days
Title
To evaluate the antiviral activity of CMX157 versus tenofovir disproxil fumarate(TDF).
Description
HBV DNA levels
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects, Cmax.
Description
Measuring Cmax(concentration maximum): the peak plasma concentration.
Time Frame
28 days
Title
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Tmax.
Description
Measuring Tmax(time maximum): the time Cmax was observed.
Time Frame
28 days
Title
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: AUC.
Description
Measuring AUC(area under the curve): area under plasma concentration versus time curve.
Time Frame
28 days
Title
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Cmin.
Description
Measuring Cmin(concentration minimum): minimum observed plasma concentration.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Sullivan-Boylai, MD
Organizational Affiliation
ContraVir Pharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
City
Bangkok
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Phase 2, Multiple Ascending Dose Proof of Concept Study
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