Back to resultsProof Of Mechanism Study To Determine Efficacy Of PF-04455242 In Blocking Spiradoline (PF-00345768) Stimulated Prolactin Release
Primary Purpose
Bipolar Depression
Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
PF-04455242
spiradoline
Placebo
spiradoline
PF-04455242
spiradoline
Sponsored by
About this trial
This is an interventional basic science trial for Bipolar Depression focused on measuring Proof of mechanism study
Eligibility 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).
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
PF-04455242 18 mg
Placebo
PF-04455242 30 mg
Arm Description
Subjects in this arm will receive a single 18 mg oral dose of PF-04455242 prior to spiradoline challenge
Subjects in this arm will receive placebo prior to spiradoline challenge.
Subjects in this arm will receive a single 30 mg oral dose of PF-04455242 prior to spiradoline challenge.
Outcomes
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).
Secondary Outcome Measures
Change from baseline to peak of serum PRL concentration.
Change from baseline to peak of plasma ACTH concentration.
Change from baseline area under the plasma ACTH concentration time curve from 0-120 minutes after intramuscular administration of PF 00345768 (spiradoline).
Plasma concentrations of PF 04455242.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00988949
Brief Title
Proof Of Mechanism Study To Determine Efficacy Of PF-04455242 In Blocking Spiradoline (PF-00345768) Stimulated Prolactin Release
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
Proof of mechanism study
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-04455242 18 mg
Arm Type
Experimental
Arm Description
Subjects in this arm will receive a single 18 mg oral dose of PF-04455242 prior to spiradoline challenge
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects in this arm will receive placebo prior to spiradoline challenge.
Arm Title
PF-04455242 30 mg
Arm Type
Experimental
Arm Description
Subjects in this arm will receive a single 30 mg oral dose of PF-04455242 prior to spiradoline challenge.
Intervention Type
Drug
Intervention Name(s)
PF-04455242
Intervention Description
Single oral 18 mg dose of PF-04455242.
Intervention Type
Drug
Intervention Name(s)
spiradoline
Intervention Description
Spiradoline 3.2 mcg/kg to be administered intramuscularly once on the morning of the spiradoline challenge day.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral placebo.
Intervention Type
Drug
Intervention Name(s)
spiradoline
Intervention Description
Spiradoline 3.2 mcg/kg to be administered intramuscularly once on the morning of the spiradoline challenge day.
Intervention Type
Drug
Intervention Name(s)
PF-04455242
Intervention Description
Single 30 mg oral dose of PF-04455242.
Intervention Type
Drug
Intervention Name(s)
spiradoline
Intervention Description
Spiradoline 3.2 mcg/kg to be administered intramuscularly once on the morning of the spiradoline challenge day.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change from baseline to peak of serum PRL concentration.
Time Frame
1 week
Title
Change from baseline to peak of plasma ACTH concentration.
Time Frame
1 week
Title
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
Title
Plasma concentrations of PF 04455242.
Time Frame
1 week
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
188770
Country
Singapore
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1071004&StudyName=Proof%20Of%20Mechanism%20Study%20To%20Determine%20Efficacy%20Of%20PF-04455242%20In%20Blocking%20Spiradoline%20%28PF-00345768%29%20Stimulated%20Prolactin%20Release
Description
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Learn more about this trial
Proof Of Mechanism Study To Determine Efficacy Of PF-04455242 In Blocking Spiradoline (PF-00345768) Stimulated Prolactin Release
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