Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 in Japanese Postmenopausal Women

NCT00826436 | Completed

• 1 other identifier: 3208A1-1008
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in Japanese postmenopausal women. The secondary purpose is to evaluate the PK and PD profile of multiple oral doses of PRA-027 in Japanese postmenopausal women.

Conditions

Uterine Leiomyomata (Fibroids)

Outcome Measures

Primary Outcomes (1)

• To assess the safety and tolerability of multiple oral doses of PRA-027 in postmenopausal women.

  28 days

Secondary Outcomes (1)

• To evaluate the Pharmacokinetics and Pharmacodynamics profile of multiple oral doses of PRA-027 in postmenopausal women.

  28 days

Study Arms (2)

8 subjects for Cohort 1

8 subjects for Cohort 2

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community sample

You may qualify if:

• Aged 35 to 65 years inclusive on study day 1 of the treatment period. Menopause may be spontaneous or due to surgery.
• Postmenopausal women are defined as follows:
• Spontaneous amenorrhea must have begun by age 55 years.
• Spontaneous amenorrhea must have initiated at least 6 months before study day 1 of the treatment period.
• For subjects who have had spontaneous amenorrhea for at least 6 months but less than 12 months before screening, follicle-stimulating hormone (FSH) level must be ≥ 38 mIU/mL.
• For subjects who have had spontaneous amenorrhea for 12 months or longer before screening, no FSH level determination is required.
• For subjects who have had amenorrhea as a result of bilateral oophorectomy without hysterectomy; surgery must have occurred at least 6 months before screening. No FSH measurement is required. Subjects must provide evidence of the procedure by an operative report or by ultrasound scan. The date (month/year) of the subjects' last menstrual period must be determined and recorded on the source document.
• Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and bodyweight ≥ 45 kg.
• BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's average height, in meters, at screening:BMI = weight (kg)/\[Height (m)\]2
• Healthy, as determined by the investigator, on the basis of screening evaluations.
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine levels should be below the upper limit of normal at screening.
• Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
• Have a high probability for compliance with and completion of the study.

You may not qualify if:

• Presence or history of any disorder that may prevent the successful completion of the study.
• Any significant cardiovascular, hepatic, renal, respiratory,gynecologic, gastrointestinal, endocrine, immunologic,dermatologic, hematologic, neurologic, or psychiatric disease.
• \- Women with asymptomatic leiomyomata may be enrolled in the study.
• Women who have undergone a hysterectomy.
• Women with complex or simple ovarian cysts greater than 3 cm indiameter.
• Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article (eg, resection of liver, kidney, gallbladder, or gastrointestinal tract).
• Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before receiving test article (treatment period study day 1).
• History of drug abuse.
• Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.
• History or presence of polycystic ovarian disease.
• History of female infertility.
• History or family history of arterial or venous thrombosis.
• Any clinically significant deviation from normal limits in results of physical examinations, vital sign measurements, 12-lead electrocardiograms (ECGs), or clinical laboratory tests.
• Demonstration of positive findings on orthostatic testing at screening. The definition of a positive finding is a ≥20 mm Hg decrease in systolic blood pressure, a ≥ 10 mm Hg decrease in diastolic blood pressure, or a ≥ 30 bpm increase in pulse, after standing for 3 minutes.
• Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

Unknown Facility

Kagoshima, Kagoshima-ken, 890-0081, Japan

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Myofibroma; Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Neoplasms, Muscle Tissue

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 20, 2009
• First Posted: January 22, 2009
• Study Start: November 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 6, 2009

Record last verified: 2009-03

Locations

JP (1)