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

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: High dose AUT00206 2000 mg; Drug: Low dose AUT00206 800mg; Drug: Placebo; Drug: Ketamine; Other: Saline

• Registration Number: NCT02935725
• Lead Sponsor: Autifony Therapeutics Limited

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-08-15
• Study Start: 2016-10
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-17
• Status Verified: 2017-11
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Last Update Submitted: 2017-11-22
• Last Update Posted: 2017-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

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).

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Exclusion Criteria

• History of, or current condition of, migraine headaches or has undergone operations to the head.
• History of significant claustrophobia.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High dose AUT00206 2000 mg + Ketamine	Ketamine	High dose AUT00206 (2000 mg) + ketamine
High dose AUT00206 2000 mg + Ketamine	High dose AUT00206 2000 mg	High dose AUT00206 (2000 mg) + ketamine
Low dose AUT00206 800 mg + Ketamine	Low dose AUT00206 800mg	Low dose AUT00206 (800 mg) + ketamine
Placebo + Ketamine	Placebo	Placebo + ketamine
Placebo + Saline	Saline	Placebo + saline
Placebo + Saline	Placebo	Placebo + saline
Low dose AUT00206 800 mg + Ketamine	Ketamine	Low dose AUT00206 (800 mg) + ketamine
Placebo + Ketamine	Ketamine	Placebo + ketamine

Primary Outcome Measures

Name	Time	Method
Significant difference in BOLD phMRI signals after dosing with AUT00206 vs placebo	15 Weeks

Trial Locations

Locations (1)

University Of Manchester; 🇬🇧 London, United Kingdom