You are here

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

Last updated on March 14, 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Uterine Leiomyomata (Fibroids)
NCT00543790
Females
18+
Years
Multiple Sites
Uterine Leiomyomata (Fibroids)
NCT00444704
Females
20+
Years
Tsukuba, Ibaraki Prefecture

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]

Call Now