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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-04455242 18 mg

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

Group Type EXPERIMENTAL

PF-04455242

Intervention Type DRUG

Single oral 18 mg dose of PF-04455242.

spiradoline

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Oral placebo.

spiradoline

Intervention Type DRUG

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

PF-04455242 30 mg

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

Group Type EXPERIMENTAL

PF-04455242

Intervention Type DRUG

Single 30 mg oral dose of PF-04455242.

spiradoline

Intervention Type DRUG

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

Interventions

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PF-04455242

Single oral 18 mg dose of PF-04455242.

Intervention Type DRUG

spiradoline

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

Intervention Type DRUG

Placebo

Oral placebo.

Intervention Type OTHER

spiradoline

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

Intervention Type DRUG

PF-04455242

Single 30 mg oral dose of PF-04455242.

Intervention Type DRUG

spiradoline

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

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes