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

Autifony Therapeutics Limited22 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Schizophrenia

Interventions

Low dose AUT00206 800mgDRUG

High dose AUT00206 2000 mgDRUG

PlaceboDRUG

KetamineDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University Of Manchester

London, United Kingdom

Outcomes

Primary Outcomes

Significant difference in BOLD phMRI signals after dosing with AUT00206 vs placebo

Time frame: 15 Weeks

Data from ClinicalTrials.gov

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