drugset / Trial / NCT00543790

Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women

NCT00543790 ↗

Phase 1 Completed 48 enrolled Wyeth is now a wholly owned subsidiary of Pfizer
RandomizedSingle-groupDouble-blindTreatment

Summary

This is the first multiple-dose study in humans with PRA-027. This study will provide an assessment of the safety, tolerability, pharmacokinetics (how the drug is absorbed, metabolized and excreted by the body) and pharmacodynamics (a measure of whether the drug is active in the body) of PRA-027 after administration of 28 days of oral doses in women of childbearing potential (cycling) or postmenopausal women.

Timeline

Start
2007-11
Primary completion
2008-12
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Subject PF-05019702 Unknown 40 mg Oral
Subject PF-05019702 Unknown 120 mg Oral
Subject PF-05019702 Unknown 240 mg Oral
Subject PF-05019702 Unknown 500 mg Oral