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Study of the Safety, Tolerability, and PK of PRA-027 Administered to Women of Nonchildbearing Potential

Last updated on October 13, 2019

FOR MORE INFORMATION
Study Location
Miami, Florida, 33126 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fibroid
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Women of nonchildbearing potential (WONCBP) aged 18 to 60 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 ultrasound scan.

- Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ³50 kg. BMI
is calculated by taking the subject's weight, in kilograms, divided by the square of
the subject's height, in meters, at screening: BMI=weight (kg)/[height (m)]2

- Healthy as determined by the investigator on the basis of screening evaluations.

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

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

- A history of drug abuse within 1 year before study day 1, a history of alcoholism
within 1 year before study day 1 or consumption of more than 2 standard units of
alcohol per day (a standard unit equals 12 ounces of beer, 1½ ounces of 80-proof
alcohol, or 6 ounces of wine). Any positive findings during the urine drug screen for
amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, and
opiates.

- Use of any investigational or prescription drug within 30 days before test article
administration. Consumption of any caffeine-containing products (eg, coffee, tea,
chocolate, or soda) 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 acetaminophen and vitamins ?100% of the recommended daily
allowance) within 14 days before study day 1.

NCT00427544
Pfizer
Completed
Study of the Safety, Tolerability, and PK of PRA-027 Administered to Women of Nonchildbearing Potential

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Descriptive Information
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 SummaryThe 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 DescriptionNot 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 DateNot Provided
Eligibility Criteria  ICMJE

INCLUSION CRITERIA

  • Women of nonchildbearing potential (WONCBP) aged 18 to 60 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 ultrasound scan.
  • Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ³50 kg. BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's height, in meters, at screening: BMI=weight (kg)/[height (m)]2
  • Healthy as determined by the investigator on the basis of screening evaluations.

EXCLUSION CRITERIA

  • Any significant cardiovascular, hepatic, renal, respiratory, gynecologic, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
  • A history of drug abuse within 1 year before study day 1, a history of alcoholism within 1 year before study day 1 or consumption of more than 2 standard units of alcohol per day (a standard unit equals 12 ounces of beer, 1½ ounces of 80-proof alcohol, or 6 ounces of wine). Any positive findings during the urine drug screen for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, and opiates.
  • Use of any investigational or prescription drug within 30 days before test article administration. Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or soda) 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 acetaminophen and vitamins ?100% of the recommended daily allowance) within 14 days before study day 1.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
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 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 DateDecember 2007

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:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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