Effects of PF-06412562 on Value-based Decision-making in Healthy Individuals

NCT03181841

Last updated date
Study Location
University Hospital Zurich, Dept. of Clinical Pharmacology and Toxicology
Zurich, , CH-8091, Switzerland
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Decision Making
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-35 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Informed Consent as documented by signature on the informed consent form

- Physically and psychiatrically healthy men and women

- Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days for females and 90 days for males after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children.

- Female subjects of non childbearing potential must meet at least one of the following criteria:

- Have undergone a documented hysterectomy and/or bilateral oophorectomy;

- Have medically confirmed ovarian failure or;

- Achieved post menopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the post menopausal state.

- All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.

- Aged 18-35 years

- Negative pregnancy test (see exclusion criteria)

- Normal or corrected-to-normal vision

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

(selected):


- Pregnant female subjects; breastfeeding female subjects


- considered to be healthy based on an extensive pre-study screening including
anamnesis, physical examination, laboratory investigations, vital signs, ECG, etc.

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Decision MakingEffects of PF-06412562 on Value-based Decision-making in Healthy Individuals
NCT03181841
  1. Zurich,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Effects of PF-06412562 on Value-based Decision-making in Healthy Individuals
Official Title  ICMJE Effects of PF-06412562 on Value-based Decision-making in Healthy Individuals: a Mono-center, Randomized, Placebo Controlled, Double-blind Study (Phase I)
Brief Summary

Numerous psychiatric and neurodegenerative diseases like schizophrenia, dependency on drugs of abuse, depression and Parkinson's disease are related to motivational and cognitive deficits in value-based decision making, which frequently persist even after a successful pharmacological treatment. According to current neurobiologic models, cortical dopamine D1 receptors play a crucial role in taking value-based decisions. In this study, it will be investigated whether value-based decisions in healthy volunteers can be improved by stimulation of D1-receptors. For this purpose, a newly developed dopamine D1-agonist will be used, which selectively increases the activities of frontal D1- and D5-receptors. In this double-blind, randomized, placebo-controlled study, the effects of different single doses of PF-06412562, a not yet licensed D1-agonist, on value-based decision making will be compared with placebo. The use of different dosage strengths will allow to investigate a potential relationship between the extent of activity of the D1-receptor and its influence on behavioral indices.

Therefore, four parallel groups will be investigated. Each participant takes in a single dose of either PF-06412562 in different doses or placebo. A screening exam will be carried out 1-3 weeks before the drug intake, and a follow-up examination will be carried out approx. 1 week after the drug intake. At all 3 visits in the study centre, several tests for the investigation of value-based decision making will be carried out.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double-blind
Primary Purpose: Basic Science
Condition  ICMJE Decision Making
Intervention  ICMJE
  • Drug: PF-06412562
    double-blind oral intake of single doses of the aforementioned drug or placebo
  • Drug: Placebo
    double-blind oral intake of single doses of the aforementioned drug or placebo
Study Arms  ICMJE
  • Experimental: Active dose 1
    Single dose of PF-06412562 in low dosage strength
    Intervention: Drug: PF-06412562
  • Experimental: Active dose 2
    Single dose of PF-06412562 in medium dosage strength
    Intervention: Drug: PF-06412562
  • Experimental: Active dose 3
    Single dose of PF-06412562 in higher dosage strength
    Intervention: Drug: PF-06412562
  • Placebo Comparator: Placebo
    Single dose of placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 8, 2017)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2018
Estimated Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed Consent as documented by signature on the informed consent form
  • Physically and psychiatrically healthy men and women
  • Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days for females and 90 days for males after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children.
  • Female subjects of non childbearing potential must meet at least one of the following criteria:

    • Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    • Have medically confirmed ovarian failure or;
    • Achieved post menopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the post menopausal state.
  • All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.
  • Aged 18-35 years
  • Negative pregnancy test (see exclusion criteria)
  • Normal or corrected-to-normal vision

Exclusion Criteria (selected):

  • Pregnant female subjects; breastfeeding female subjects
  • considered to be healthy based on an extensive pre-study screening including anamnesis, physical examination, laboratory investigations, vital signs, ECG, etc.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03181841
Other Study ID Numbers  ICMJE PHA-16-D1AGO-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Philippe Tobler, Prof. Dr.University of Zurich, Dept. of Economics
Principal Investigator:Alexander Jetter, MDUniversity of Zurich
PRS Account University of Zurich
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP