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drugset / Trial / NCT00948662

Study Evaluating The Safety And Tolerability Of Administration Of Single Oral Doses Of SAM-760 To Healthy Subjects

NCT00948662 ↗

Phase 1 Completed 124 enrolled Pfizer
RandomizedParallel-groupTriple-blindTreatment

Summary

This study will assess the safety and tolerability of ascending single oral doses of SAM-760 in healthy young adult and healthy elderly subjects. The secondary objectives are to provide the concentrations of SAM-760 in the blood and to evaluate the effect of a high-fat meal on the concentrations in the blood of SAM-760 administered to healthy young adult subjects, and to evaluate the effects of concomitant administration of ketoconazole on the safety and the concentrations of SAM-760 in the blood of a single dose of SAM-760 in healthy young adult subjects.

Timeline

Start
2009-09
Primary completion
2010-12
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketoconazole Small molecule 200 mg Oral
Subject PF-05212377 Small molecule 0.25 mg Oral
Subject PF-05212377 Small molecule 0.75 mg Oral
Subject PF-05212377 Small molecule 2.25 mg Oral
Subject PF-05212377 Small molecule 5 mg Oral
Subject PF-05212377 Small molecule 10 mg Oral
Subject PF-05212377 Small molecule 15 mg Oral
Subject PF-05212377 Small molecule 20 mg Oral
Subject PF-05212377 Small molecule 25 mg Oral
Subject PF-05212377 Small molecule 35 mg Oral
Subject PF-05212377 Small molecule 45 mg Oral

Indications

No indication recorded.