Study of the Safety, Tolerability, and PK of PRA-027 Administered to Women of Nonchildbearing Potential
NCT00427544
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Fibroid
Sex
Female
Age
18-60 years
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FibroidStudy of the Safety, Tolerability, and PK of PRA-027 Administered to Women of Nonchildbearing Potential
NCT00427544
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Advanced Information
Descriptive Information | ||||
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Brief Title ICMJE | Study of the Safety, Tolerability, and PK of PRA-027 Administered to Women of Nonchildbearing Potential | |||
Official Title ICMJE | Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRA-027 Administered Orally to Healthy Women of Nonchildbearing Potential | |||
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 | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Primary Purpose: Treatment | |||
Condition ICMJE | Fibroid | |||
Intervention ICMJE | Drug: PRA-027 | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | Not Provided | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | August 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | INCLUSION CRITERIA
EXCLUSION CRITERIA
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 60 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00427544 | |||
Other Study ID Numbers ICMJE | 3208A1-1000 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | December 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |