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

Schizophrenia Clinical Trial

Official title:

A Phase 1, Single-centre, Double-blind, Placebocontrolled Crossover Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Male Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935725
• Other study ID #: AUT021206
• Secondary ID: 2016-000216-14
• Status: Completed
• Phase: Phase 1
• First received: August 15, 2016
• Last updated: November 22, 2017
• Start date: October 2016
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: Autifony Therapeutics Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase 1, Single-centre, Double-blind, Placebo controlled Crossover Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Male Participants

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Low dose AUT00206 800mg

• High dose AUT00206 2000 mg

• Placebo

• Ketamine

Other:
• Saline

Locations

Country	Name	City	State
United Kingdom	University Of Manchester	London

Sponsors (2)

Lead Sponsor	Collaborator
Autifony Therapeutics Limited	University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant difference in BOLD phMRI signals after dosing with AUT00206 vs placebo		15 Weeks