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

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ClinicalTrials.gov Identifier: NCT02935725
Recruitment Status : Completed
First Posted : October 17, 2016
Last Update Posted : November 27, 2017
Sponsor:
Collaborator:
University of Manchester
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Low dose AUT00206 800mg Drug: High dose AUT00206 2000 mg Drug: Placebo Drug: Ketamine Other: Saline Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Single-centre, Double-blind, Placebocontrolled Crossover Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Male Participants
Actual Study Start Date : October 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low dose AUT00206 800 mg + Ketamine
Low dose AUT00206 (800 mg) + ketamine
Drug: Low dose AUT00206 800mg
Drug: Ketamine
Experimental: High dose AUT00206 2000 mg + Ketamine
High dose AUT00206 (2000 mg) + ketamine
Drug: High dose AUT00206 2000 mg
Drug: Ketamine
Placebo Comparator: Placebo + Ketamine
Placebo + ketamine
Drug: Placebo
Drug: Ketamine
Placebo Comparator: Placebo + Saline
Placebo + saline
Drug: Placebo
Other: Saline



Primary Outcome Measures :
  1. Significant difference in BOLD phMRI signals after dosing with AUT00206 vs placebo [ Time Frame: 15 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935725


Locations
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United Kingdom
University Of Manchester
London, United Kingdom
Sponsors and Collaborators
Autifony Therapeutics Limited
University of Manchester
Investigators
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Principal Investigator: Bill Deakin, Prof University of Manchester

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Responsible Party: Autifony Therapeutics Limited
ClinicalTrials.gov Identifier: NCT02935725     History of Changes
Other Study ID Numbers: AUT021206
2016-000216-14 ( EudraCT Number )
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made publicly available on completion of the trial.

Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action