Back to resultsSafety, Tolerability and Pharmacokinetics of AUT00206 in Patients With Schizophrenia, and Also Explores the Effects of AUT00206 on Relevant Central Biomarkers.
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
AUT00206
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Key inclusion Criteria:
- Male patients with a diagnosis of schizophrenia no more than 5 calendar years (before screening);
- Positive and negative symptoms assessed by PANSS;
- Medically and psychiatrically stable;
- On a stable dose of antipsychotic drugs;
- Able to give fully informed written consent and likely to comply with the requirements of the trial.
Key exclusion Criteria:
- clinically relevant, as assessed by a physician, abnormal findings at the screening assessment;
- sensitivity to excipients of the trial medication;
- current use of contraindicated drugs;
- participation in another clinical trial of unlicensed medicines within the previous 30 days;
- loss of more than 400 mL blood, within the previous 3 months; history of drug or alcohol dependence in the last year;
- significant acute or chronic illness;
- significant medical history or concurrent medical condition that warrants exclusion;
- objection by subject's physician
Sites / Locations
- King's College London Institute of Psychiatry, Psychology and Neuroscience (IoPPN)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dose AUT00206 800 mg BD
Placebo
Arm Description
AUT00206 800mg twice daily for 28 days
Placebo to match AUT00206 twice daily for 28 days
Outcomes
Primary Outcome Measures
Number of Participants With Treatment-Related Adverse Events over 28 days treatment of AUT00206 compared to Placebo
Plasma concentrations of AUT00206
Secondary Outcome Measures
Full Information
NCT ID
NCT03164876
First Posted
May 19, 2017
Last Updated
July 30, 2020
Sponsor
Autifony Therapeutics Limited
Collaborators
King's College London
1. Study Identification
Unique Protocol Identification Number
NCT03164876
Brief Title
Safety, Tolerability and Pharmacokinetics of AUT00206 in Patients With Schizophrenia, and Also Explores the Effects of AUT00206 on Relevant Central Biomarkers.
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
April 3, 2019 (Actual)
Study Completion Date
April 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Autifony Therapeutics Limited
Collaborators
King's College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose AUT00206 800 mg BD
Arm Type
Experimental
Arm Description
AUT00206 800mg twice daily for 28 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to match AUT00206 twice daily for 28 days
Intervention Type
Drug
Intervention Name(s)
AUT00206
Intervention Description
4 capsules of 200mg AUT00206, twice daily, to take orally with food for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
4 capsules of placebo, twice daily, to take orally with food for 4 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Related Adverse Events over 28 days treatment of AUT00206 compared to Placebo
Time Frame
28 days
Title
Plasma concentrations of AUT00206
Time Frame
28 days
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male 18-50 Years
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key inclusion Criteria:
Male patients with a diagnosis of schizophrenia no more than 5 calendar years (before screening);
Positive and negative symptoms assessed by PANSS;
Medically and psychiatrically stable;
On a stable dose of antipsychotic drugs;
Able to give fully informed written consent and likely to comply with the requirements of the trial.
Key exclusion Criteria:
clinically relevant, as assessed by a physician, abnormal findings at the screening assessment;
sensitivity to excipients of the trial medication;
current use of contraindicated drugs;
participation in another clinical trial of unlicensed medicines within the previous 30 days;
loss of more than 400 mL blood, within the previous 3 months; history of drug or alcohol dependence in the last year;
significant acute or chronic illness;
significant medical history or concurrent medical condition that warrants exclusion;
objection by subject's physician
Facility Information:
Facility Name
King's College London Institute of Psychiatry, Psychology and Neuroscience (IoPPN)
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety, Tolerability and Pharmacokinetics of AUT00206 in Patients With Schizophrenia, and Also Explores the Effects of AUT00206 on Relevant Central Biomarkers.
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