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
  Purpose

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.


Condition Intervention Phase
Bipolar Depression
Drug: PF-04455242
Drug: spiradoline
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: November 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Placebo Comparator: Placebo
Subjects in this arm will receive placebo prior to spiradoline challenge.
Other: Placebo
Oral placebo.
Drug: spiradoline
Spiradoline 3.2 mcg/kg to be administered intramuscularly once on the morning of the spiradoline challenge day.
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 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.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988949

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00988949     History of Changes
Other Study ID Numbers: B1071004
Study First Received: October 1, 2009
Last Updated: January 5, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Proof of mechanism study

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Spiradoline
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Diuretics
Natriuretic Agents

ClinicalTrials.gov processed this record on August 18, 2014