NCT02935725

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_1 schizophrenia

Timeline
Completed

Started Oct 2016

Typical duration for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

1.1 years

First QC Date

August 15, 2016

Last Update Submit

November 22, 2017

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

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

    15 Weeks

Study Arms (4)

Low dose AUT00206 800 mg + Ketamine

EXPERIMENTAL

Low dose AUT00206 (800 mg) + ketamine

Drug: Low dose AUT00206 800mgDrug: Ketamine

High dose AUT00206 2000 mg + Ketamine

EXPERIMENTAL

High dose AUT00206 (2000 mg) + ketamine

Drug: High dose AUT00206 2000 mgDrug: Ketamine

Placebo + Ketamine

PLACEBO COMPARATOR

Placebo + ketamine

Drug: PlaceboDrug: Ketamine

Placebo + Saline

PLACEBO COMPARATOR

Placebo + saline

Drug: PlaceboOther: Saline

Interventions

Low dose AUT00206 800mgDRUG
Low dose AUT00206 800 mg + Ketamine
High dose AUT00206 2000 mgDRUG
High dose AUT00206 2000 mg + Ketamine
PlaceboDRUG
Placebo + KetaminePlacebo + Saline
KetamineDRUG
High dose AUT00206 2000 mg + KetamineLow dose AUT00206 800 mg + KetaminePlacebo + Ketamine
SalineOTHER
Placebo + Saline

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • History of, or current condition of, migraine headaches or has undergone operations to the head.
  • History of significant claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Manchester

London, United Kingdom

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

KetamineSodium Chloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Bill Deakin, Prof

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2016

First Posted

October 17, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

November 27, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will share

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

Locations

GB(1)