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

Phase 1

Completed

• Conditions: Bipolar Depression
• Interventions: Drug: PF-04455242; Other: Placebo; Drug: spiradoline

• Registration Number: NCT00988949
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-01
• Study First Submitted QC: 2009-10-01
• Study First Posted: 2009-10-02
• Study Start: 2009-11
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-05
• Last Update Posted: 2010-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-04455242 18 mg	PF-04455242	Subjects in this arm will receive a single 18 mg oral dose of PF-04455242 prior to spiradoline challenge
PF-04455242 18 mg	spiradoline	Subjects in this arm will receive a single 18 mg oral dose of PF-04455242 prior to spiradoline challenge
Placebo	Placebo	Subjects in this arm will receive placebo prior to spiradoline challenge.
PF-04455242 30 mg	PF-04455242	Subjects in this arm will receive a single 30 mg oral dose of PF-04455242 prior to spiradoline challenge.
Placebo	spiradoline	Subjects in this arm will receive placebo prior to spiradoline challenge.
PF-04455242 30 mg	spiradoline	Subjects in this arm will receive a single 30 mg oral dose of PF-04455242 prior to spiradoline challenge.

Primary Outcome Measures

Name	Time	Method
Change from baseline area under the serum PRL concentration time curve from 0 to 120 minutes after intramuscular administration of PF 00345768 (spiradoline).	1 week

Secondary Outcome Measures

Name	Time	Method
Change from baseline to peak of serum PRL concentration.	1 week
Change from baseline to peak of plasma ACTH concentration.	1 week
Change from baseline area under the plasma ACTH concentration time curve from 0-120 minutes after intramuscular administration of PF 00345768 (spiradoline).	1 week
Plasma concentrations of PF 04455242.	1 week
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	1 week

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore