Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03181841
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03181841
Recruitment Status : Unknown
Verified June 2017 by University of Zurich.
Recruitment status was:  Enrolling by invitation
First Posted : June 9, 2017
Last Update Posted : June 9, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date  ICMJE May 12, 2017
First Posted Date  ICMJE June 9, 2017
Last Update Posted Date June 9, 2017
Actual Study Start Date  ICMJE May 8, 2017
Estimated Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
  • Change from baseline in a delay discounting task. [ Time Frame: 1-3 weeks before (= baseline), 5 hours after, and approx. 1 week after drug intake. ]
    This validated computer-based decision-making test will be filled in by each participant at three time points during the study: 1-3 weeks before, 5 hours after, and approx. 1 week after a single oral intake of 1 out of 3 possible doses of PF-06412562, or matching placebo.
  • Change from baseline in a risk discounting task. [ Time Frame: 1-3 weeks before (= baseline), 5 hours after, and approx. 1 week after drug intake. ]
    This validated computer-based decision-making test will be filled in by each participant at three time points during the study: 1-3 weeks before, 5 hours after, and approx. 1 week after a single oral intake of 1 out of 3 possible doses of PF-06412562, or matching placebo. It will be carried out after the test for outcome 1.
  • Effect of PF-06412562 on an effort discounting task (compared to placebo). [ Time Frame: 5 hours after drug intake. ]
    This validated computer-based decision-making test will be completed by each participant 5 hours after a single oral intake of 1 out of 3 possible doses of PF-06412562, or matching placebo and after having completed the tests for outcome 1 and 2.
  • Effect of PF-06412562 on the Pavlovian to instrumental transfer task (compared to placebo). [ Time Frame: 5 hours after drug intake. ]
    This validated computer-based decision-making task tests Pavlovian acquisition and transfer. It will be carried out by each participant immediately after the test in outcome 3.
  • Effect of PF-06412562 on an exploration / exploitation task (compared to placebo). [ Time Frame: 5 hours after drug intake. ]
    This validated computer-based decision-making task tests different aspects of value-based decision making. It will be carried out by each participant immediately after the test in outcome 4.
  • Effect of PF-06412562 on a probabilistic reversal learning task (compared to placebo). [ Time Frame: 5 hours after drug intake. ]
    This validated computer-based decision-making task tests different aspects of value-based decision making. It will be carried out by each participant immediately after the test in outcome 5.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
Incidence of treatment-emergent adverse events (safety and tolerability of PF-06412562) [ Time Frame: throughout the study and up to 1 week after study drug intake. ]
continuous assessment of adverse events by non-leading questions, repeated safety laboratory tests, repeated ECGs, repeated control of vital parameters.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 8, 2017)
Plasma concentrations of PF-06412562 [ Time Frame: blood sampling 4 hours and 8 hours after the study drug intake. ]
Original Other Pre-specified Outcome Measures Same as current
 
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, MD University 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