A Study to Assess the pharmacoMRI Effects of AUT00206 in... | NCT02935725

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

NCT02935725

Sponsor

Autifony Therapeutics Limited

Status

Completed

Last Update Posted

Nov 27, 2017Actual

Enrollment

22Actual

Phase

Phase 1

Conditions

Schizophrenia

Interventions

Low dose AUT00206 800mg
High dose AUT00206 2000 mg
Placebo
Ketamine
Saline

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2016-000216-14	EudraCT Number

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016Actual

Primary Completion Date

Nov 2017Actual

Completion Date

Nov 2017Actual

First Submitted Date

Aug 15, 2016

First Submission Date that Met QC Criteria

Oct 14, 2016

First Posted Date

Oct 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2017

Last Update Posted Date

Nov 27, 2017Actual

Name	Class
University of Manchester	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low dose AUT00206 800 mg + Ketamine	Experimental	Low dose AUT00206 (800 mg) + ketamine	Drug: Low dose AUT00206 800mg Drug: Ketamine
High dose AUT00206 2000 mg + Ketamine	Experimental	High dose AUT00206 (2000 mg) + ketamine	Drug: High dose AUT00206 2000 mg Drug: Ketamine
Placebo + Ketamine	Placebo Comparator	Placebo + ketamine	Drug: Placebo Drug: Ketamine
Placebo + Saline	Placebo Comparator	Placebo + saline	Drug: Placebo Other: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low dose AUT00206 800mg	Drug		Low dose AUT00206 800 mg + Ketamine
High dose AUT00206 2000 mg

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bill Deakin, Prof	University of Manchester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Of Manchester		London			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007649	Ketamine
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided