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

November 22, 2017 updated by: Autifony Therapeutics Limited

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Significant difference in BOLD phMRI signals after dosing with AUT00206 vs placebo
Time Frame: 15 Weeks
15 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Autifony Therapeutics Limited

Collaborators

University of Manchester

Investigators

  • Principal Investigator: Bill Deakin, Prof, University of Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

August 15, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimate)

October 17, 2016

Study Record Updates

Last Update Posted (Actual)

November 27, 2017

Last Update Submitted That Met QC Criteria

November 22, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUT021206
  • 2016-000216-14 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be made publicly available on completion of the trial.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe