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This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | CMX157, tablet, 5 mg, QD, 14 days versus CMX157 placebo, 5 mg, tablet, QD, 14 days |
|
| Group B | Experimental | CMX157, tablet, 10 mg, QD, 14 days versus CMX157, placebo tablet, 10 mg, QD, 14 days |
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| Group C | Experimental | CMX157, tablet, 25 mg, QD, 14 days versus placebo CMX157, placebo tablet, 25 mg, QD, 14 days |
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| Group D | Experimental | CMX157, tablet, 50 mg, QD, 14 days versus CMX157, placebo tablet, 50 mg, QD, 14 days |
|
| Group E | Experimental | CMX157, tablet, 100 mg, QD, 14 days versus CMX157, placebo tablet, 100 mg, QD, 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMX157 | Drug | Oral tablet |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Sullivan-Bolyai, MD, MPH | ContraVir | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangkok | Thailand |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| 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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| placebo | Drug | Oral tablet |
|
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 |