A Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Males
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Low dose AUT00206 800mg
High dose AUT00206 2000 mg
Placebo
Ketamine
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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.
Sites / Locations
- University Of Manchester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Low dose AUT00206 800 mg + Ketamine
High dose AUT00206 2000 mg + Ketamine
Placebo + Ketamine
Placebo + Saline
Arm Description
Low dose AUT00206 (800 mg) + ketamine
High dose AUT00206 (2000 mg) + ketamine
Placebo + ketamine
Placebo + saline
Outcomes
Primary Outcome Measures
Significant difference in BOLD phMRI signals after dosing with AUT00206 vs placebo
Secondary Outcome Measures
Full Information
NCT ID
NCT02935725
First Posted
August 15, 2016
Last Updated
November 22, 2017
Sponsor
Autifony Therapeutics Limited
Collaborators
University of Manchester
1. Study Identification
Unique Protocol Identification Number
NCT02935725
Brief Title
A Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Males
Official Title
A Phase 1, Single-centre, Double-blind, Placebocontrolled Crossover Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Male Participants
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Autifony Therapeutics Limited
Collaborators
University of Manchester
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Phase 1, Single-centre, Double-blind, Placebo controlled Crossover Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Male Participants
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose AUT00206 800 mg + Ketamine
Arm Type
Experimental
Arm Description
Low dose AUT00206 (800 mg) + ketamine
Arm Title
High dose AUT00206 2000 mg + Ketamine
Arm Type
Experimental
Arm Description
High dose AUT00206 (2000 mg) + ketamine
Arm Title
Placebo + Ketamine
Arm Type
Placebo Comparator
Arm Description
Placebo + ketamine
Arm Title
Placebo + Saline
Arm Type
Placebo Comparator
Arm Description
Placebo + saline
Intervention Type
Drug
Intervention Name(s)
Low dose AUT00206 800mg
Intervention Type
Drug
Intervention Name(s)
High dose AUT00206 2000 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Type
Other
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Significant difference in BOLD phMRI signals after dosing with AUT00206 vs placebo
Time Frame
15 Weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bill Deakin, Prof
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Manchester
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made publicly available on completion of the trial.
Learn more about this trial
A Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Males
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