Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

August 10, 2009
January 5, 2010
September 2009
December 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00956956 on ClinicalTrials.gov Archive Site
Effect of multiple-doses of PF 04455242 on serum prolactin concentration. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Multiple Dose Study To Determine Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Healthy Adult Subjects
A Phase I, Randomized, Placebo Controlled, Multiple Dose Study To Determine Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Healthy Adult Subjects

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy
  • 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.
  • Experimental: PF-04455242 treatment
    Intervention: Drug: PF-04455242
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2009
December 2009   (final data collection date for primary outcome measure)

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).
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00956956
B1071002
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2010

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