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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02935725

Enrollment

Registered

2016-10-17

Start date

2016-10-31

Completion date

2017-11-30

Last updated

2017-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Brief summary

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

Interventions

DRUGLow dose AUT00206 800mg

DRUGHigh dose AUT00206 2000 mg

DRUGPlacebo

DRUGKetamine

OTHERSaline

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026