Study Stopped
Study recruitment was terminated on 14 June 2016 due to a Pfizer business decision. This study was not terminated for reasons of safety.
A Study To Examine Safety, Pharmacokinetics, And Pharmacodynamic Of Pf 06412562 In Healthy Males
A Randomized,Subject And Investigator Blind, Sponsor Open Placebo Controlled, Parallel Phase 1b Study To Examine The Safety, Pharmacokinetics, And Pharmacodynamic Effects Of Pf-06412562 On Cognitive And Reward/Motivation Domains In Healthy Male Volunteers Selected By Cognitive Phenotype
1 other identifier
interventional
77
1 country
3
Brief Summary
This study is designed to investigate the safety, tolerability pharmacokinetics and pharmacodynamic effects of PF-06412562 following multiple dose administration as MR tablets in healthy adult males.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jan 2015
Longer than P75 for phase_1 healthy
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2014
CompletedFirst Posted
Study publicly available on registry
December 3, 2014
CompletedStudy Start
First participant enrolled
January 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2016
CompletedAugust 17, 2017
August 1, 2017
1.4 years
November 20, 2014
August 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
change from baseline for Columbia Suicide Severity Rating Scale
Columbia Suicide Severity Rating Scale
Screening, Day 1, Day 7 and Follow-up
Secondary Outcomes (1)
Cavg: Average plasma PF-06412562 and PF-06663872 concentrations at steady state
Day 4, 6 and 8
Study Arms (3)
PF-06412562 3mg
EXPERIMENTALPF-06412562 3mg BID
Placebo
PLACEBO COMPARATORPlacebo BID
PF-06412562 15mg
EXPERIMENTALPF-06412562 15mg BID
Interventions
Eligibility Criteria
You may qualify if:
- Medically healthy
- Male
- Right-handed aged
- years
- BMI 17.5 to 35kg/m2.
You may not qualify if:
- Females
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of screening and at the time of dosing).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (3)
Arcadia MRI & Imaging Center
Arcadia, California, 91007, United States
California Clinical Trials Medical Group
Glendale, California, 91206, United States
Glendale Adventist Medical Center
Glendale, California, 91206, United States
Related Publications (1)
Balice-Gordon R, Honey GD, Chatham C, Arce E, Duvvuri S, Naylor MG, Liu W, Xie Z, DeMartinis N, Harel BT, Braley GH, Kozak R, Park L, Gray DL. A Neurofunctional Domains Approach to Evaluate D1/D5 Dopamine Receptor Partial Agonism on Cognition and Motivation in Healthy Volunteers With Low Working Memory Capacity. Int J Neuropsychopharmacol. 2020 May 27;23(5):287-299. doi: 10.1093/ijnp/pyaa007.
PMID: 32055822DERIVED
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2014
First Posted
December 3, 2014
Study Start
January 19, 2015
Primary Completion
June 14, 2016
Study Completion
June 14, 2016
Last Updated
August 17, 2017
Record last verified: 2017-08