SchizophreniaPhase 1NCT02935725
A Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Males
A Phase 1 study testing Low dose AUT00206 800mg, High dose AUT00206 2000 mg and Ketamine in people with Schizophrenia, run by Autifony Therapeutics Limited at 1 site in United Kingdom.
Trial summary
A Phase 1, Single-centre, Double-blind, Placebo controlled Crossover Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Male Participants Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Low dose AUT00206 800mg, High dose AUT00206 2000 mg and Ketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2016to Nov 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- History of, or current condition of, migraine headaches or has undergone operations to the head.
- History of significant claustrophobia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-centre, Double-blind, Placebocontrolled Crossover Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Male Participants
A Phase 1, Single-centre, Double-blind, Placebo controlled Crossover Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Male Participants
- Conditions
- Schizophrenia
- Being tested
- Low dose AUT00206 800mg, High dose AUT00206 2000 mg, Placebo, Ketamine, Saline
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose AUT00206 800mgDrug
High dose AUT00206 2000 mgDrug
PlaceboDrug
KetamineDrug
SalineOther
| Study group | Role | What they receive |
|---|---|---|
| Low dose AUT00206 800 mg + Ketamine | Experimental | Low dose AUT00206 (800 mg) + ketamine Receives: Drug: Low dose AUT00206 800mg; Drug: Ketamine |
| High dose AUT00206 2000 mg + Ketamine | Experimental | High dose AUT00206 (2000 mg) + ketamine Receives: Drug: High dose AUT00206 2000 mg; Drug: Ketamine |
| Placebo + Ketamine | Placebo comparator | Placebo + ketamine Receives: Drug: Placebo; Drug: Ketamine |
| Placebo + Saline | Placebo comparator | Placebo + saline Receives: Drug: Placebo; Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant difference in BOLD phMRI signals after dosing with AUT00206 vs placebo
Measured: 15 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Autifony Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
- Investigators
- Bill Deakin, Prof, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935725
- Sponsor's protocol ID
- AUT021206
- Other IDs
- 2016-000216-14, 2016
- Status last verified
- Nov 2017
- First submitted
- 15 Aug 2016
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be made publicly available on completion of the trial.
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-centre, Double-blind, Placebocontrolled Crossover Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT02935725
- Acronym / sponsor ID
- AUT021206
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Autifony Therapeutics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- University of Manchester
- Study start
- Oct 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1, Single-centre, Double-blind, Placebo controlled Crossover Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Male Participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose AUT00206 800 mg + Ketamine | Experimental | Drug: Low dose AUT00206 800mg, Drug: KetamineLow dose AUT00206 (800 mg) + ketamine |
| High dose AUT00206 2000 mg + Ketamine | Experimental | Drug: High dose AUT00206 2000 mg, Drug: KetamineHigh dose AUT00206 (2000 mg) + ketamine |
| Placebo + Ketamine | Placebo comparator | Drug: Placebo, Drug: KetaminePlacebo + ketamine |
| Placebo + Saline | Placebo comparator | Drug: Placebo, Other: SalinePlacebo + saline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- History of, or current condition of, migraine headaches or has undergone operations to the head.
- History of significant claustrophobia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose AUT00206 800mg | Drug | Low dose AUT00206 800 mg + Ketamine |
| High dose AUT00206 2000 mg | Drug | High dose AUT00206 2000 mg + Ketamine |
| Placebo | Drug | Placebo + Ketamine, Placebo + Saline |
| Ketamine | Drug | High dose AUT00206 2000 mg + Ketamine, Low dose AUT00206 800 mg + Ketamine, Placebo + Ketamine |
| Saline | Other | Placebo + Saline |
Primary outcome
Significant difference in BOLD phMRI signals after dosing with AUT00206 vs placebo
Time frame: 15 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Individual participant dataSharing planned: Yes. Data will be made publicly available on completion of the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bill Deakin, Prof principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low dose AUT00206 800mg, High dose AUT00206 2000 mg and Ketamine in people with Schizophrenia, run by Autifony Therapeutics Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant difference in BOLD phMRI signals after dosing with AUT00206 vs placebo (time frame: 15 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.