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OpenTrials
Completed

NCT Number: NCT02935725

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

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

Completed

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University Of Manchester

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low dose AUT00206 800mg

Drug

High dose AUT00206 2000 mg

Drug

Placebo

Drug

ketamine

Drug

Saline

Other

Primary outcomes

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

    Time frame: 15 Weeks

Sponsors and collaborators

Lead sponsor

Autifony Therapeutics Limited

Industry

Collaborators

  • University of Manchester

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2016
Registry last updated
Nov 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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