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

NCT00988949 | Completed Phase 1

• 1 other identifier: B1071004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Depression

Keywords

Proof of mechanism study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (3)

PF-04455242 18 mg

EXPERIMENTAL

Subjects in this arm will receive a single 18 mg oral dose of PF-04455242 prior to spiradoline challenge

Drug: PF-04455242; Drug: spiradoline

Placebo

PLACEBO COMPARATOR

Subjects in this arm will receive placebo prior to spiradoline challenge.

Other: Placebo; Drug: spiradoline

PF-04455242 30 mg

EXPERIMENTAL

Subjects in this arm will receive a single 30 mg oral dose of PF-04455242 prior to spiradoline challenge.

Drug: PF-04455242; Drug: spiradoline

Interventions

PF-04455242 DRUG

Single oral 18 mg dose of PF-04455242.

PF-04455242 18 mg

spiradoline DRUG

Spiradoline 3.2 mcg/kg to be administered intramuscularly once on the morning of the spiradoline challenge day.

PF-04455242 18 mg

Placebo OTHER

Oral placebo.

Placebo

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Links

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

MeSH Terms

Conditions

Bipolar Disorder

Interventions

2-methyl-N-((2'-(pyrrolidin-1-ylsulfonyl)biphenyl-4-yl)methyl)propan-1-amine; spiradoline

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 7, 2010

Record last verified: 2010-01

Locations

SG (1)