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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change from baseline area under the serum PRL concentration time curve from 0 to 120 minutes after intramuscular administration of PF 00345768 (spiradoline).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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).
Arms & Interventions
PF-04455242 18 mg
Subjects in this arm will receive a single 18 mg oral dose of PF-04455242 prior to spiradoline challenge
Intervention: PF-04455242 (Drug)
PF-04455242 18 mg
Subjects in this arm will receive a single 18 mg oral dose of PF-04455242 prior to spiradoline challenge
Intervention: spiradoline (Drug)
Placebo
Subjects in this arm will receive placebo prior to spiradoline challenge.
Intervention: Placebo (Other)
Placebo
Subjects in this arm will receive placebo prior to spiradoline challenge.
Intervention: spiradoline (Drug)
PF-04455242 30 mg
Subjects in this arm will receive a single 30 mg oral dose of PF-04455242 prior to spiradoline challenge.
Intervention: PF-04455242 (Drug)
PF-04455242 30 mg
Subjects in this arm will receive a single 30 mg oral dose of PF-04455242 prior to spiradoline challenge.
Intervention: spiradoline (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Change from baseline to peak of serum PRL concentration.(1 week)
- Change from baseline to peak of plasma ACTH concentration.(1 week)
- Change from baseline area under the plasma ACTH concentration time curve from 0-120 minutes after intramuscular administration of PF 00345768 (spiradoline).(1 week)
- Plasma concentrations of PF 04455242.(1 week)
- 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(1 week)