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Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese Females

Last updated on November 30, 2019

FOR MORE INFORMATION
Study Location
Tsukuba, Ibaraki Prefecture, 305-0856 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Uterine Leiomyomata (Fibroids)
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-64 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Women of nonchildbearing potential aged 20 to 64 years. Must have a negative pregnancy
test result within 48 hours before administration of test article. Women who are
surgically sterile must provide documentation of the procedure by an operative report
or by ultrasound scan.

2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight must be at
least 45 kg.

3. Healthy as determined by the investigator on the basis of screening evaluation.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Any significant cardiovascular, hepatic, renal, respiratory, gynecologic
gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or
psychiatric disease.

2. Any history of drug abuse or admitted alcohol abuse or history of alcohol use that may
interfere with the subject's ability to comply with the protocol requirements.

3. Use of any investigational drug within 90 days before study day 1, use of any
prescription drug within 30 days before study day 1, consumption of any
caffeine-containing products (eg, coffee, tea, chocolate, or cola) or alcoholic
beverages within 48 hours before study day 1, consumption of grapefruit or
grapefruit-containing products within 72 hours before study day 1, use of any
over-the-counter drugs, including herbal supplements (except for the occasional use of
vitamins ?100% of the recommended daily allowance), within 14 days before study day 1,
or the donation of blood within 90 days before study day 1.

NCT00444704
Pfizer
Completed
Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese Females

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Descriptive Information
Brief Title  ICMJE Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese Females
Official Title  ICMJE Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRA-027 Administered Orally to Healthy Japanese Females
Brief SummaryThe primary purpose of this study is to assess the safety and tolerability of ascending single oral doses of PRA-027 in healthy Japanese females. The secondary purpose is to provide the initial pharmacokinetic and pharmacodynamic profiles of PRA-027 in healthy Japanese female subjects.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Uterine Leiomyomata (Fibroids)
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 December 2007
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

INCLUSION CRITERIA

  1. Women of nonchildbearing potential aged 20 to 64 years. Must have a negative pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan.
  2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight must be at least 45 kg.
  3. Healthy as determined by the investigator on the basis of screening evaluation.

EXCLUSION CRITERIA

  1. Any significant cardiovascular, hepatic, renal, respiratory, gynecologic gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
  2. Any history of drug abuse or admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.
  3. Use of any investigational drug within 90 days before study day 1, use of any prescription drug within 30 days before study day 1, consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola) or alcoholic beverages within 48 hours before study day 1, consumption of grapefruit or grapefruit-containing products within 72 hours before study day 1, use of any over-the-counter drugs, including herbal supplements (except for the occasional use of vitamins ?100% of the recommended daily allowance), within 14 days before study day 1, or the donation of blood within 90 days before study day 1.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 20 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00444704
Other Study ID Numbers  ICMJE 3208A1-1002
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateJuly 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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