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This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMX157 5mg versus TDF | Active Comparator | CMX157, 5mg tablet, 28 days versus TDF(tenofovir disoproxil fumerate) 300mg tablet, 28 days |
|
| CMX157 10mg versus TDF | Active Comparator | CMX157, 10mg tablet, 28 days versus TDF 300mg tablet, 28 days |
|
| CMX157 25mg versus TDF | Active Comparator | CMX157, 25mg tablet, 28 days versus TDF 300mg tablet, 28 days |
|
| CMX157 50mg versus TDF | Active Comparator | CMX157, 50mg tablet, 28 days versus TDF 300mg tablet, 28 days |
|
| CMX157 100mg versus TDF | Active Comparator | CMX157, 100mg tablet, 28 days versus TDF 300mg tablet, 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMX157 | Drug | tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| To evaluate the antiviral activity of CMX157 versus tenofovir disproxil fumarate(TDF). | HBV DNA levels | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects, Cmax. | Measuring Cmax(concentration maximum): the peak plasma concentration. | 28 days |
| Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Tmax. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Sullivan-Boylai, MD | ContraVir Pharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangkok | Thailand |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C524480 | hexadecyloxypropyl 9-(2-(phosphonomethoxy)propyl)adenine |
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|
| TDF | Drug | 300mg tablet |
|
|
Measuring Tmax(time maximum): the time Cmax was observed. |
| 28 days |
| 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 |
| Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Cmin. | Measuring Cmin(concentration minimum): minimum observed plasma concentration. | 28 days |
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |