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.

Study Overview

• Status: Completed
• Conditions: Bipolar Depression
• Intervention / Treatment: Drug: PF-04455242; Drug: spiradoline; Drug: PF-04455242; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 188770
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-04455242 18 mg; Subjects in this arm will receive a single 18 mg oral dose of PF-04455242 prior to spiradoline challenge	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.; Drug: PF-04455242; Single 30 mg oral dose of PF-04455242.
Placebo Comparator: Placebo; Subjects in this arm will receive placebo prior to spiradoline challenge.	Drug: spiradoline; Spiradoline 3.2 mcg/kg to be administered intramuscularly once on the morning of the spiradoline challenge day.; Other: Placebo; Oral placebo.
Experimental: PF-04455242 30 mg; Subjects in this arm will receive a single 30 mg oral dose of PF-04455242 prior to spiradoline challenge.	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.; Drug: PF-04455242; Single 30 mg oral dose of PF-04455242.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: October 1, 2009
• First Submitted That Met QC Criteria: October 1, 2009
• First Posted (Estimate): October 2, 2009

Study Record Updates

• Last Update Posted (Estimate): January 7, 2010
• Last Update Submitted That Met QC Criteria: January 5, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Proof of mechanism study
• Additional Relevant MeSH Terms: Mental Disorders; Bipolar and Related Disorders; Bipolar Disorder; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Natriuretic Agents; Diuretics; Spiradoline
• Other Study ID Numbers: B1071004