Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Males

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: NCT02935725
Recruitment Status : Completed
First Posted : October 17, 2016
Last Update Posted : November 27, 2017
Sponsor:
Collaborator:
University of Manchester
Information provided by (Responsible Party):
Autifony Therapeutics Limited

Tracking Information
First Submitted Date  ICMJE August 15, 2016
First Posted Date  ICMJE October 17, 2016
Last Update Posted Date November 27, 2017
Actual Study Start Date  ICMJE October 2016
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
Significant difference in BOLD phMRI signals after dosing with AUT00206 vs placebo [ Time Frame: 15 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Males
Official Title  ICMJE A Phase 1, Single-centre, Double-blind, Placebocontrolled Crossover Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Male Participants
Brief Summary A Phase 1, Single-centre, Double-blind, Placebo controlled Crossover Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Male Participants
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Low dose AUT00206 800mg
  • Drug: High dose AUT00206 2000 mg
  • Drug: Placebo
  • Drug: Ketamine
  • Other: Saline
Study Arms  ICMJE
  • Experimental: Low dose AUT00206 800 mg + Ketamine
    Low dose AUT00206 (800 mg) + ketamine
    Interventions:
    • Drug: Low dose AUT00206 800mg
    • Drug: Ketamine
  • Experimental: High dose AUT00206 2000 mg + Ketamine
    High dose AUT00206 (2000 mg) + ketamine
    Interventions:
    • Drug: High dose AUT00206 2000 mg
    • Drug: Ketamine
  • Placebo Comparator: Placebo + Ketamine
    Placebo + ketamine
    Interventions:
    • Drug: Placebo
    • Drug: Ketamine
  • Placebo Comparator: Placebo + Saline
    Placebo + saline
    Interventions:
    • Drug: Placebo
    • Other: Saline
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 Completed
Actual Enrollment  ICMJE
 (submitted: November 22, 2017)
22
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2016)
16
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male aged 18 to 45 years, inclusive at Visit 1.
  • Healthy on the basis of medical history, psychiatric history, physical examination, vital signs, 12-lead electrocardiogram (ECG), haematology, blood chemistry and urinalysis within 6 weeks of Visit 2.
  • Right-handed.
  • Not a regular smoker (maximum 5 cigarettes per week or equivalent).

Exclusion Criteria:

  • History of, or current condition of, migraine headaches or has undergone operations to the head.
  • History of significant claustrophobia.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02935725
Other Study ID Numbers  ICMJE AUT021206
2016-000216-14 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data will be made publicly available on completion of the trial.
Responsible Party Autifony Therapeutics Limited
Study Sponsor  ICMJE Autifony Therapeutics Limited
Collaborators  ICMJE University of Manchester
Investigators  ICMJE
Principal Investigator: Bill Deakin, Prof University of Manchester
PRS Account Autifony Therapeutics Limited
Verification Date November 2017

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