Proof Of Mechanism Study To Determine Efficacy Of PF-04455242 In Blocking Spiradoline (PF-00345768) Stimulated Prolactin Release
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00988949
First received: October 1, 2009
Last updated: January 5, 2010
Last verified: January 2010
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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 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 May 16, 2013