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This is the first-in-human study for an oral investigational compound, PF-06282999, in order to assess its safety, tolerability and pharmacokinetics in humans across a wide range of dose levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
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| Cohort 2 | Experimental |
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| Cohort 3 | Experimental |
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| Cohort 4 | Experimental |
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| Cohort 5 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06282999 | Drug | Solution, doses range from 20 to 200 mg, single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose | |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose | |
| Area Under the Curve From Time Zero to 24 hour [AUC24] | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose | |
| Maximum Observed Plasma Concentration (Cmax) | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose | |
| Apparent Oral Clearance (CL/F) | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose | |
| Plasma Decay Half-Life (t1/2) | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose | |
| Apparent Volume of Distribution (Vz/F) | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose | |
| Amount of Unchanged Drug Excretion in Urine from Zero to 24 hours (Ae24) | 0 to 24 hours post-dose | |
| Percent of Dose Excreted in Urine as Unchanged Drug from Zero to 24 hours (Ae24%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Brussels | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Placebo |
| Drug |
Solution, single dose |
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| PF-06282999 | Drug | Methylcellulose suspension, doses range 125 to 500 mg, single dose |
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| Placebo | Drug | suspension, single dose |
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| PF-06282999 | Drug | Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose |
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| Placebo | Drug | suspension, single dose |
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| PF-06282999 | Drug | Methylcellulose or simethicone suspension, 500 mg dose, single dose |
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| Placebo | Drug | suspension, single dose |
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| PF-06282999 | Drug | Simethicone or methylcellulose suspension, up to 1500 mg, single dose |
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| Placebo | Drug | suspension, single dose |
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| 0 to 24 hours post-dose |
| Renal Clearance (CLr) | 0 to 24 hours post-dose |
| Oral temperature | 0, 1, 2, 4, 8, 12,16, 24, 48 hours post-dose |
| ID | Term |
|---|---|
| C000605149 | 2-(6-(5-chloro-2-methoxyphenyl)-4-oxo-2-thioxo-3,4-dihydropyrimidin-1(2H)-yl)acetamide |
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