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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PNU-100480 (PF-02341272) after a single dose in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1, Sequence 1 | Experimental | Period 1- Placebo Period 2- 100 mg Period 3- 300 mg |
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| Cohort 1, Sequence 2 | Experimental | Period 1- 35 mg Period 2- Placebo Period 3- 300 mg |
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| Cohort 1, Sequence 3 | Experimental | Period 1- 35 mg Period 2- 100 mg Period 3- Placebo |
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| Cohort 2, Sequence 1 | Experimental | Period 1- Placebo Period 2- 1000 mg Period 3- 1500 mg Period 4- 600 mg (Fed conditions) |
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| Cohort 2, Sequence 2 | Experimental | Period 1- 600 mg Period 2- Placebo Period 3- 1500 mg Period 4- 600 mg (Fed conditions) |
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| Cohort 2, Sequence 3 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PNU-100480 | Drug | 100 mg oral suspension given once |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of safety and tolerability of escalating single oral doses of PNU-100480. | Daily, Days 1-3 or 4, and 7-14 days after dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize pharmacokinetics of single oral doses PNU-100480. | Predose; multiple timepoints postdose on Day 1, and up to 72 hours postdose. | |
| Characterize the effect of food on the pharmacokinetics of a single oral dose of PNU-100480. | Predose; multiple timepoints postdose on Day 1, and up to 72 hours postdose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Beth Ferstenberg, M.D. | Sequella, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20629533 | Derived | Wallis RS, Jakubiec WM, Kumar V, Silvia AM, Paige D, Dimitrova D, Li X, Ladutko L, Campbell S, Friedland G, Mitton-Fry M, Miller PF. Pharmacokinetics and whole-blood bactericidal activity against Mycobacterium tuberculosis of single doses of PNU-100480 in healthy volunteers. J Infect Dis. 2010 Sep 1;202(5):745-51. doi: 10.1086/655471. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Period 1- 600 mg Period 2- 1000 mg Period 3- Placebo Period 4- 600 mg (Fed conditions) |
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| PNU-100480 | Drug | 300 mg oral suspension given once |
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| Placebo | Drug | placebo to match oral suspension given once |
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| PNU-100480 | Drug | 300 mg oral suspension given once |
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| PNU-100480 | Drug | 35 mg oral suspension given once |
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| Placebo | Drug | placebo to match oral suspension given once |
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| PNU-100480 | Drug | 100 mg oral suspension given once |
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| PNU-100480 | Drug | 35 mg oral suspension given once |
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| Placebo | Drug | placebo to match oral suspension given once |
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| PNU-100480 | Drug | 1000 mg oral suspension given once |
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| PNU-100480 | Drug | 1500 mg oral suspension given once |
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| PNU-100480 | Drug | Fed conditions, 600 mg oral suspension given once |
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| Placebo | Drug | placebo to match oral suspension given once |
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| PNU-100480 | Drug | 1500 mg oral suspension given once |
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| PNU-100480 | Drug | 600 mg oral suspension given once |
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| PNU-100480 | Drug | Fed conditions, 600 mg oral suspension given once |
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| Placebo | Drug | placebo to match oral suspension given once |
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| PNU-100480 | Drug | 1000 mg oral suspension given once |
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| PNU-100480 | Drug | 600 mg oral suspension given once |
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| PNU-100480 | Drug | Fed conditions, 600 mg oral suspension given once |
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| Placebo | Drug | placebo to match oral suspension given once |
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| Characterize the bactericidal activity in blood of orally administered PNU-100480 against intracellular Mycobacterium tuberculosis in relation to blood concentrations of PNU-100480 (and its metabolites) (some periods only) | Predose and timpoints up to 24 hours post dose on Day 1 (only in some periods) |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C543015 | PNU-100480 |
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