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This study is a Phase 1, single-center, open-label, single-dose study to evaluate (1) the absorption, metabolism, and excretion patterns of a single dose of [14C] PA-824, and (2) the pharmacokinetics, safety, and tolerability of a single oral-suspension dose of unlabeled PA-824 in healthy adult male subjects. Unlabeled PA-824 and [14C]-PA-824 will be administered together in an oral-suspension formulation. Enrollment is planned for one dose group of 6 subjects. All 6 subjects will receive the same treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PA-824 | Experimental | [14C]-PA-824 and unlabelled PA-824 oral suspension of 1000 mg unlabeled micronized PA-824 mixed with sufficient [14C]-PA-824 to achieve a final radiolabel dose of approximately 100 µCi/dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PA-824 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the plasma pharmacokinetic variable area under the curve of a single oral-suspension dose of PA-824. | Characterize the plasma pharmacokinetics of a single oral-suspension dose of PA-824 in healthy adult male subjects by calculating the variable area under the curve [AUC (0-t)] from total PA-824 plasma concentrations. | Days 0-12 |
| Characterize the plasma pharmacokinetic variable maximum concentration of a single oral-suspension dose of PA-824. | Characterize the plasma pharmacokinetics of a single oral-suspension dose of PA-824 in healthy adult male subjects by calculating the variable maximum plasma concentration (Cmax) from total PA-824 plasma concentrations. | Days 0-12 |
| Characterize the plasma pharmacokinetic variable time to peak plasma concentration of a single oral-suspension dose of PA-824. | Characterize the plasma pharmacokinetics of a single oral-suspension dose of PA-824 in healthy adult male subjects by calculating the variable time to peak plasma concentration (Tmax) from total PA-824 plasma concentrations. | Days 0-12 |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency and severity of treatment related adverse events throughout the study. | In order to evaluate the safety and tolerability of a single oral-suspension dose of PA-824 in healthy adult male subjects | Days 0 -12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Bridson, MD | Covance CRU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| C410767 | pretomanid |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |