Trials / Completed
CompletedNCT03164876
Safety, Tolerability and Pharmacokinetics of AUT00206 in Patients With Schizophrenia, and Also Explores the Effects of AUT00206 on Relevant Central Biomarkers.
A Randomised, Double-blind, Placebo-controlled Study of the Safety, Pharmacokinetics and Exploratory Pharmacodynamics of AUT00206 for 28 Days as Adjunctive Therapy in Patients With Recently Diagnosed Schizophrenia
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Autifony Therapeutics Limited · Industry
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
This study will investigate the safety, tolerability, PK and PD profile of AUT00206 after repeated doses in patients with stable but symptomatic schizophrenia, taking one or two established anti-psychotic drugs. The subjects will undergo brain imaging, tests of cognition and tests of auditory function and electrophysiological measures in addition to routine safety monitoring. Because of the pioneering and novel mechanism of action of this drug, a key objective is to characterize this range of biomarkers which will inform the future development of the drug.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AUT00206 | 4 capsules of 200mg AUT00206, twice daily, to take orally with food for 4 weeks |
| DRUG | Placebo | 4 capsules of placebo, twice daily, to take orally with food for 4 weeks |
Timeline
- Start date
- 2017-04-20
- Primary completion
- 2019-04-03
- Completion
- 2019-04-03
- First posted
- 2017-05-24
- Last updated
- 2020-07-31
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03164876. Inclusion in this directory is not an endorsement.