A Multiple Dose Study To Determine Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Healthy Adult Subjects

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00956956

First received: August 10, 2009

Last updated: January 5, 2010

Last verified: January 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

August 10, 2009

Last Updated Date

January 5, 2010

Start Date ^ICMJE

September 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and tolerability of multiple ascending doses of PF 04455242 administered orally to healthy adult subjects. [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Plasma and urine pharmacokinetics of multiple ascending doses of PF 04455242 administered orally to healthy adult subjects. [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00956956 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Effect of multiple-doses of PF 04455242 on serum prolactin concentration. [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Multiple Dose Study To Determine Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Healthy Adult Subjects

Official Title ^ICMJE

A Phase I, Randomized, Placebo Controlled, Multiple Dose Study To Determine Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Healthy Adult Subjects

Brief Summary

The goals of this study are to evaluate the safety and tolerability of multiple ascending doses of PF-04455242 administered orally to healthy adult subjects. In addition, the plasma and urine pharmacokinetics of multiple ascending doses of PF 04455242 administered orally to healthy adult subjects will be evaluated. Finally, the effect of multiple-doses of PF-04455242 on serum prolactin concentration will be explored.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: PF-04455242
3, 6, and 23 mg capsules administered orally Q6 hours for 7 days of dosing.
Drug: Placebo
Placebo administered orally Q6 hours for 7 days of dosing.

Study Arm (s)

Experimental: PF-04455242 treatment
Intervention: Drug: PF-04455242
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy male and/or female subjects without childbearing potential between the ages of 21 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).

Gender

Both

Ages

21 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Singapore

Administrative Information

NCT Number ^ICMJE

NCT00956956

Other Study ID Numbers ^ICMJE

B1071002

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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