Healthy VolunteersPhase 1NCT03141658
Effects of TS-134 on Ketamine-induced BOLD Signals in Healthy Subjects
A Phase 1 study testing TS-134 and Ketamine in people with Healthy Volunteers, run by Taisho Pharmaceutical R&D Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of TS-134 on ketamine-induced BOLD signals in ROIs in resting fMRI in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TS-134 and Ketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2017to 10 Apr 2018
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male and female subjects between 18 and 55 years of age inclusive (at the time of initial informed consent)
- Body weight ≥ 45 and ≤ 87 kg
- Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2
Who cannot join
- Female subjects who are pregnant, intend to become pregnant, or are breastfeeding
- History or presence of psychiatric or neurologic disease or condition
- History of first-degree relative with schizophrenia or mood disorder with psychosis
- History of alcohol or drug abuse
- History of recreational ketamine use, recreational PCP use, or an adverse reaction to ketamine
- History of violence
Show all 11Show fewer
- Presence or positive history of significant medical illness, including high blood pressure, low blood pressure or orthostatic hypotension
- Any subjects who show subthreshold ketamine BOLD response
- Metal implants, pacemaker, other metal or paramagnetic objects contained within the body
- Claustrophobia
- Subject with any history of suicidal behavior or is currently at risk of suicide in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: A Randomized, Single-blind, Parallel-group Study to Evaluate the Effects of TS-134 on Ketamine-induced BOLD Signals in Resting fMRI in Healthy Adult Subjects
The purpose of this study is to evaluate the effects of TS-134 on ketamine-induced BOLD signals in ROIs in resting fMRI in healthy adult subjects.
- Conditions
- Healthy Volunteers
- Being tested
- TS-134, Placebo, Ketamine
- Keywords
- TS-134, ketamine, fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-134Drug
Multiple dose titrations from 10 mg to 20 mg once daily for 6 days
TS-134Drug
Multiple dose titrations from 10 mg to 60 mg once daily for 6 days
PlaceboDrug
Multiple doses of placebo once daily for 6 days
KetamineOther
0.23 mg/kg bolus over one minute on Screening (baseline) and Day 6
| Study group | Role | What they receive |
|---|---|---|
| TS-134 20 mg | Experimental | Not described Receives: Drug: TS-134; Other: Ketamine |
| TS-134 60 mg | Experimental | Not described Receives: Drug: TS-134; Other: Ketamine |
| Placebo | Experimental | Not described Receives: Drug: Placebo; Other: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD fMRI signals in pre-specified ROIs
Changes in ketamine-induced BOLD fMRI signals in pre-specified ROIs (anterior cingulate cortex (ACC) and anterior insula) following administrations of TS-134
Measured: Screening and Day 6
Secondary outcomes (3)
BOLD fMRI signals in whole brain
Changes in ketamine-induced BOLD fMRI signals in whole brain following administrations of TS-134
Measured: Screening and Day 6
Brief Psychiatric Rating Scale (BPRS)
Changes in BPRS scores following administrations of TS-134
Measured: Screening and Day 6
Clinician Administered Dissociative State Scale (CADSS)
Changes in CADSS scores following administrations of TS-134
Measured: Screening and Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start28 Jun 2017
- Primary completion4 Apr 2018
- Study completion10 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical R&D Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey A Lieberman, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141658
- Sponsor's protocol ID
- TS134-US103
- Status last verified
- Apr 2018
- First submitted
- 3 May 2017
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Parallel-group Study to Evaluate the Effects of TS-134 on Ketamine-induced BOLD Signals in Resting fMRI in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03141658
- Acronym / sponsor ID
- TS134-US103
- Conditions
- Healthy Volunteers
- Keywords
- TS-134, ketamine, fMRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical R&D Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 4 Apr 2018 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 5 May 2017 (actual)
- 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.
The purpose of this study is to evaluate the effects of TS-134 on ketamine-induced BOLD signals in ROIs in resting fMRI in healthy adult subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TS-134 20 mg | Experimental | Drug: TS-134, Other: Ketamine |
| TS-134 60 mg | Experimental | Drug: TS-134, Other: Ketamine |
| Placebo | Experimental | Drug: Placebo, Other: Ketamine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult male and female subjects between 18 and 55 years of age inclusive (at the time of initial informed consent)
- Body weight ≥ 45 and ≤ 87 kg
- Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2
Key exclusion criteria (11 listed)
- Female subjects who are pregnant, intend to become pregnant, or are breastfeeding
- History or presence of psychiatric or neurologic disease or condition
- History of first-degree relative with schizophrenia or mood disorder with psychosis
- History of alcohol or drug abuse
- History of recreational ketamine use, recreational PCP use, or an adverse reaction to ketamine
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 |
|---|---|---|
| TS-134Multiple dose titrations from 10 mg to 20 mg once daily for 6 days | Drug | TS-134 20 mg |
| TS-134Multiple dose titrations from 10 mg to 60 mg once daily for 6 days | Drug | TS-134 60 mg |
| PlaceboMultiple doses of placebo once daily for 6 days | Drug | Placebo |
| Ketamine0.23 mg/kg bolus over one minute on Screening (baseline) and Day 6 | Other | Placebo, TS-134 20 mg, TS-134 60 mg |
Primary outcome
BOLD fMRI signals in pre-specified ROIs
Time frame: Screening and Day 6
Changes in ketamine-induced BOLD fMRI signals in pre-specified ROIs (anterior cingulate cortex (ACC) and anterior insula) following administrations of TS-134
3 secondary outcomes
BOLD fMRI signals in whole brain
Time frame: Screening and Day 6
Brief Psychiatric Rating Scale (BPRS)
Time frame: Screening and Day 6
Clinician Administered Dissociative State Scale (CADSS)
Time frame: Screening and Day 6
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 30 Apr 2018.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Jeffrey A Lieberman, MD principal investigator
New York State Psychiatric Institute
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 TS-134 and Ketamine in people with Healthy Volunteers, run by Taisho Pharmaceutical R&D Inc. at 1 site in United States.
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 3 inclusion and 11 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 30 Apr 2018. 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 States. 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. 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?
BOLD fMRI signals in pre-specified ROIs (time frame: Screening and Day 6). 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 30 Apr 2018.