Study Evaluating Safety, Tolerability, Pharmacokinetics & Pharmacodynamics

Clinical Trial 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.

See also
	Status	Clinical Trial	Phase
	Completed	`NCT00543790` - Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women	Phase 1
	Completed	`NCT00444704` - Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese Females	Phase 1

See also

Status

Clinical Trial

Phase

Completed

NCT00543790 - Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women

Phase 1

Completed

NCT00444704 - Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese Females

Phase 1

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT00826436
Study type	Observational
Source	Wyeth is now a wholly owned subsidiary of Pfizer
Contact
Status	Completed
Phase	N/A
Start date	November 2008
Completion date	March 2009

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms