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

Autifony Therapeutics

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: High dose AUT00206 2000 mg; Other: Saline; Drug: Ketamine; Drug: Placebo; Drug: Low dose AUT00206 800mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02935725

2016-000216-14 (EudraCT Number)

AUT021206

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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22 participants in 4 patient groups, including a placebo group

Low dose AUT00206 800 mg + Ketamine

Experimental group

Description:

Low dose AUT00206 (800 mg) + ketamine

Treatment:

Drug: Low dose AUT00206 800mg

Drug: Ketamine

High dose AUT00206 2000 mg + Ketamine

Experimental group

Description:

High dose AUT00206 (2000 mg) + ketamine

Treatment:

Drug: High dose AUT00206 2000 mg

Drug: Ketamine

Placebo + Ketamine

Placebo Comparator group

Description:

Placebo + ketamine

Treatment:

Drug: Placebo

Drug: Ketamine

Placebo + Saline

Placebo Comparator group

Description:

Placebo + saline

Treatment:

Drug: Placebo

Other: Saline