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

Last updated on October 5, 2018

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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Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRA-027 Administered Orally to Healthy Women of Nonchildbearing Potential
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Not Provided
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Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
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Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
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Not Provided

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.
Sexes Eligible for Study: Female
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00427544
3208A1-1000
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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