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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


Phase 1
18 Years
60 Years
Not Enrolling
Female
Fibroid

Thank you

Trial Information

Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRA-027 Administered Orally to Healthy Women of Nonchildbearing Potential

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Outcome Measure:

The primary outcome of this study is to asess the safety and tolerability of ascending single oral doses of PRA-027 in healthy women of nonchildbearing potential.

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3208A1-1000

NCT ID:

NCT00427544

Start Date:

February 2007

Completion Date:

August 2007

Related Keywords:

  • Fibroid
  • Uterine leiomyomata (Fibroids)
  • Leiomyoma
  • Myofibroma

Name

Location

Miami, Florida  33176