Spots Global Cancer Trial Database for Study of the Safety, Tolerability, and PK of PRA-027 Administered to Women of Nonchildbearing Potential
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Trial Identification
Brief Title: Study of the Safety, Tolerability, and PK of PRA-027 Administered to Women of Nonchildbearing Potential
Official Title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRA-027 Administered Orally to Healthy Women of Nonchildbearing Potential
Study ID: NCT00427544
Conditions
Interventions
Study Description
Brief Summary: The primary purpose of this study is to asess the safety and tolerability of ascending single oral doses of PRA-027 in healthy women of nonchildbearing potential. The secondary purpose is to provide the initial pharmacokinetic (PK) and pharmacodynamic (PD) profile of PRA-027 in healthy women of nonchildbearing potential, and to evaluate the effect of a high-fat meal on the PK and PD of PRA-027 administered to healthy women of nonchildbearing potential.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
, Miami, Florida, United States
Contact Details
Name: Medical Monitor
Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
Role: STUDY_DIRECTOR
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