A Study To Examine Safety, Pharmacokinetics, And Pharmacodynamic Of Pf 06412562 In Healthy Males

August 14, 2017 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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. The study will be comprised of 2 analytical stages. Both analytical stages will be conducted as randomized, subject and investigator blind, sponsor open, placebo-controlled, parallel design. Study enrollment will be continuous through Stage I and Stage II. Stage I consists of approximately 45 completer subjects (approximately 15 per arm). Stage I is an exploratory hypothesis generation stage. No multiple comparison adjustment will be conducted for the Stage I analysis. The sample size in Stage I is based on operational feasibility. All endpoints including the composite scores will be tested at the end of Stage I. Each PF-06412562 dose (3 mg BID and 15 mg BID) will be compared to the placebo arm for each endpoint. Up to 5 comparisons that meet Stage I decision criteria will be treated as primary comparisons in Stage II (see Data Analysis section). Stage II is a hypothesis testing stage in which multiple comparisons will be adjusted and overall type I error rate will be controlled across all primary comparisons. Stage II will be formally powered to study those endpoints/doses most likely to demonstrate the strongest pharmacodynamic signal. Stage II will not exceed 56 completers (~21 in each PF-06412562 arm and ~14 in placebo arm). Study enrollment will be continuous through Stage I and Stage II. The three treatments in both stages include (i) PF-06412562 3 mg BID (ii) PF-06412562 15 mg BID, and (iii) placebo. Separate placebo groups, contemporaneous with the treatment groups, will be recruited for Stage I and Stage II. A total of approximately 101 subjects will be randomly assigned to one of the 3 treatments. If a subject drops out before completing the study, or withdraws for reasons unrelated to the safety of the test treatment, the subject will be replaced at the discretion of the Sponsor in consultation with the investigator. Subjects with fMRI or ERP data that does not pass imaging or ERP data QC will also be replaced.

Subjects will be randomized to a specific treatment arm according to the randomization schedule provided to the site by Pfizer. Two doses of PF-06412562 (3 mg and 15 mg), administered as MR tablets, will be given twice daily (BID) from Day 1 through Day 6. A loading dose of PF-06412562 will be administered as an IR tablet on Day 1 only to facilitate rapid attainment of concentration into the target range. For subjects assigned to the 3 mg BID group, one 3 mg MR tablet and one

1 mg PF-06412562 IR tablet will be administered. For subjects assigned to the 15 mg BID group, one 15 mg MR tablet and one 5 mg IR dose of PF-06412562 will be administered.

On Day 7 only the morning dose will be administered. Subject participation will be approximately 12 days (and 11 nights), excluding screening and follow-up. Screening activities will be completed up to 28 days prior to admission to the study on Day -3. The follow-up visit is conducted approximately 7 to 10 days after the last dose of study drug administration. Medically healthy, right-handed male subjects, aged 18-45 will be screened for working memory capacity, psychiatric disorders and other cognitive/educational constrains. Subjects who meet all entry criteria will be randomized into one of the three treatment arms.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Arcadia, California, United States, 91007
        • Arcadia MRI & Imaging Center
      • Glendale, California, United States, 91206
        • California Clinical Trials Medical Group
      • Glendale, California, United States, 91206
        • Glendale Adventist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Medically healthy
  • Male
  • Right-handed aged
  • 18-45 years
  • BMI 17.5 to 35kg/m2.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo BID
Other: Placebo
Placebo
Experimental: PF-06412562 3mg
PF-06412562 3mg BID
Drug: PF-06412562 3mg BID
PF-06412562
Other Names:
  • PF-06412562 3mg
Experimental: PF-06412562 15mg
PF-06412562 15mg BID
Drug: PF-06412562 15mg BID
PF-06412562
Other Names:
  • PF-06412562 15mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change from baseline for Columbia Suicide Severity Rating Scale
Time Frame: Screening, Day 1, Day 7 and Follow-up
Columbia Suicide Severity Rating Scale
Screening, Day 1, Day 7 and Follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cavg: Average plasma PF-06412562 and PF-06663872 concentrations at steady state
Time Frame: Day 4, 6 and 8
Average plasma PF-06412562 and PF-06663872 concentrations for each dose at times 0, 5, and 12 hours on days 4 and 6, as well as 0 hours on Day 8
Day 4, 6 and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 14, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B7441004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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