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The purpose of this study in healthy people is to investigate the safety, toleration and time course of UK-396,082 concentration in the blood and any changes in relevant markers of drug effects, following multiple doses given twice daily by mouth for 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Subjects will be assigned to receive either UK-396,082 or placebo |
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| Cohort 2 | Experimental | Subjects will be assigned to receive either UK-396,082 or placebo |
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| Cohort 3 | Experimental | Subjects will be assigned to receive either UK-396,082 or placebo |
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| Cohort 4 | Experimental | Subjects will be assigned to receive either UK-396,082 or placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UK-396,082 | Drug | 100mg given orally twice daily for 14 days The decision to proceed to the next higher dose will be made jointly by the Pfizer Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts and dosing periods. The doses will be selected such that the predicted Cmax will not exceed 2.95 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose. |
| Measure | Description | Time Frame |
|---|---|---|
| safety & toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetics: Cmax, Tmax, AUCtau, t½, Rac (=AUCtau (Day 14)/AUCtau (Day 1)), CL/F, Vz/f, Cmin, Cav Urine pharmacokinetics: Aetau & Aetau%, CLR on Day 14 | 14 days | |
| Time course of changes in prothrombin time, activated partial thromboplastin time, TAFi inhibition, fibrinogen and D-dimer concentrations. |
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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 | 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 | given orally twice daily for 14 days |
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| UK-396,082 | Drug | 300mg given orally twice daily for 14 days The decision to proceed to the next higher dose will be made jointly by the Pfizer Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts and dosing periods. The doses will be selected such that the predicted Cmax will not exceed 2.95 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose. |
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| placebo | Drug | given orally twice daily for 14 days |
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| UK-396,082 | Drug | 1000mg given orally twice daily for 14 days The decision to proceed to the next higher dose will be made jointly by the Pfizer Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts and dosing periods. The doses will be selected such that the predicted Cmax will not exceed 2.95 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose. |
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| placebo | Drug | given orally twice daily for 14 days |
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| UK-396,082 | Drug | UK-396,082 given orally, once on Days 1 & 14, and twice daily on Days 3-13. The decision to proceed to the next higher dose will be made jointly by the Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts. Dependent on the emerging safety, tolerability and PK data, Cohort 4 may be recruited to study a higher (or lower) dose of UK-396,082 in order to characterize further the safety, toleration and PK and/or to define the maximum tolerated dose. The dose in Cohort 4 will be selected such that the predicted Cmax will not exceed 46 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose. |
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| placebo | Drug | given orally, once on Days 1 & 14, and twice daily on Days 3-13. |
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| 14 days |
| ID | Term |
|---|---|
| C526817 | 5-amino-2-((1-n-propyl-1H-imidazol-4-yl)methyl)pentanoic acid |
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