Proof Of Mechanism Study To Determine Efficacy Of PF-04455242 In Blocking Spiradoline (PF-00345768) Stimulated Prolactin Release

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00988949
First received: October 1, 2009
Last updated: January 5, 2010
Last verified: January 2010

October 1, 2009
January 5, 2010
November 2009
December 2009   (final data collection date for primary outcome measure)
Change from baseline area under the serum PRL concentration time curve from 0 to 120 minutes after intramuscular administration of PF 00345768 (spiradoline). [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00988949 on ClinicalTrials.gov Archive Site
  • Change from baseline to peak of serum PRL concentration. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Change from baseline to peak of plasma ACTH concentration. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Change from baseline area under the plasma ACTH concentration time curve from 0-120 minutes after intramuscular administration of PF 00345768 (spiradoline). [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Plasma concentrations of PF 04455242. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Clinical monitoring of safety and tolerability will include physical exam and neurological assessment, clinical safety laboratory results, 12 lead ECGs, vital signs, suicidality assessment, and adverse event monitoring [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Proof Of Mechanism Study To Determine Efficacy Of PF-04455242 In Blocking Spiradoline (PF-00345768) Stimulated Prolactin Release
Phase I, Randomized, Placebo Controlled Proof Of Mechanism Study To Determine Efficacy Of PF-04455242 In Blocking Spiradoline (PF-00345768) Stimulated Prolactin Release In Healthy Male Adult Subjects

This study will be a Proof of Mechanism (POM) study to establish evidence of central pharmacodynamic activity for PF 04455242, and will be a parallel group, randomized, double blind, sponsor open study conducted in healthy male subjects. Once subjects achieve steady state of PF 04455242, they will undergo PF 00345768 (spiradoline) challenge. Data will be analyzed to determine whether PF-04455242 blocks spiradoline induced prolactin release.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Bipolar Depression
  • Drug: PF-04455242
    Single oral 18 mg dose of PF-04455242.
  • Drug: spiradoline
    Spiradoline 3.2 mcg/kg to be administered intramuscularly once on the morning of the spiradoline challenge day.
  • Other: Placebo
    Oral placebo.
  • Drug: PF-04455242
    Single 30 mg oral dose of PF-04455242.
  • Experimental: PF-04455242 18 mg
    Subjects in this arm will receive a single 18 mg oral dose of PF-04455242 prior to spiradoline challenge
    Interventions:
    • Drug: PF-04455242
    • Drug: spiradoline
  • Placebo Comparator: Placebo
    Subjects in this arm will receive placebo prior to spiradoline challenge.
    Interventions:
    • Other: Placebo
    • Drug: spiradoline
  • Experimental: PF-04455242 30 mg
    Subjects in this arm will receive a single 30 mg oral dose of PF-04455242 prior to spiradoline challenge.
    Interventions:
    • Drug: PF-04455242
    • Drug: spiradoline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male subjects 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, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Male
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00988949
B1071004
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