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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Bipolar Depression

Treatments: Drug: PF-04455242; Drug: spiradoline; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00988949

B1071004

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

PF-04455242 18 mg

Experimental group

Description:

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

Treatment:

Drug: spiradoline

Drug: spiradoline

Drug: PF-04455242

Drug: PF-04455242

Drug: spiradoline

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: spiradoline

Drug: spiradoline

Other: Placebo

Drug: spiradoline

PF-04455242 30 mg

Experimental group

Description:

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

Treatment:

Drug: spiradoline

Drug: spiradoline

Drug: PF-04455242

Drug: PF-04455242

Drug: spiradoline