NCT00988949

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pfizer · Industry
• Sex: Male
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
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	spiradoline	Spiradoline 3.2 mcg/kg to be administered intramuscularly once on the morning of the spiradoline challenge day.
DRUG	PF-04455242	Single 30 mg oral dose of PF-04455242.
DRUG	spiradoline	Spiradoline 3.2 mcg/kg to be administered intramuscularly once on the morning of the spiradoline challenge day.

Timeline

• Start date: 2009-11-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-10-02
• Last updated: 2010-01-07

Locations

1 site across 1 country: Singapore