Epilepsy, Molecular Mechanisms of Pharmalogical Action, Protective AgentsPhase 1NCT02497235

A Phase 1 Positron Emission Tomography Study to Measure Cholesterol 24S-Hydroxylase Target Occupancy of TAK-935

A Phase 1 study testing TAK-935 and [18F]MNI-792 (tracer) in people with Epilepsy, Molecular Mechanisms of Pharmalogical Action, Protective Agents, run by Takeda at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the brain cholesterol 24S-hydroxylase (CH24H) enzyme occupancy of TAK-935 after single oral dose in healthy participants using the positron emission tomography (PET) ligand [18F]MNI-792 and PET imaging and to determine the relationship of occupancy to TAK-935 exposure. Read more about this study

Who is it for?: Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Epilepsy, Molecular Mechanisms of Pharmalogical Action, Protective Agents
What is being tested?: TAK-935 and [18F]MNI-792 (tracer)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: Jul 2015to Jan 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 19 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

In the opinion of the investigator, is capable of understanding and complying with protocol requirements.
Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.
Is a healthy male or female and aged 19 to 55 years, inclusive, at the time of informed consent and first study medication dose.
Weighs at least 45 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m^2), inclusive at Screening.
A female of non-bearing potential (example post-menopausal by history; or history of hysterectomy, bilateral salpingectomy, or oophorectomy).

Who cannot join

Have a known history or evidence of a clinically significant disorder (including neurologic and psychiatric), or disease that in the opinion of the study investigator would pose a risk to the participant safety or interfere with the study evaluation, procedures or completion.
Contraindication to magnetic resonance imaging (MRI) based on the standard MRI radiography screening questionnaire.
Had exposure to any radiation greater than (>) 15 millisievert (mSv)/year (example, occupational or radiation therapy) within the previous year prior to Baseline imaging.
Has a known hypersensitivity to any component of the formulation of TAK-935 or related compounds, or to [18F]MNI-792 or to any of its components.
Clinically significant abnormal findings on brain MRI scan or findings on brain MRI that may interfere with the interpretation of the PET imaging.
Use of any over-the-counter, herbal, or prescription medications or supplements within 30 days prior to baseline imaging.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
New Haven, Connecticut

Other trials in United States

About this study

Official title: An Open-Label, Positron Emission Tomography, Phase 1 Study With [18F]MNI-792 to Determine Cholesterol 24S-Hydroxylase Target Occupancy of TAK-935 After Single-Dose Oral Administration in Healthy Subjects.

Read the detailed description

The drug being tested in this study is called TAK-935. TAK-935 is being tested to examine the degree and duration of brain CH24H enzyme occupancy/target engagement as a function of TAK-935 plasma concentration in order to guide dosing and schedule for future clinical trials with TAK-935. This study will utilize the PET ligand [18F]MNI-792 to evaluate the brain CH24H occupancy of TAK-935 after single dose oral administration in healthy adult participants. The study will evaluate up to 16 participants. The first 2 participants will take TAK-935 600 mg oral solution and undergo PET imaging using tracer [18F]MNI-792 up to 5 mcg (up to 370 MBq), injection, intravenously prior to each PET scan at Baseline, 45 minutes and 10 hours post-TAK-935 dose. TAK-935 dose and timing of post-dose scans for subsequent participants will be based on the data from the previous participants. This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 55 days. Participants will make 4 visits to the clinic, including 2 confinement periods to the clinic for PET imaging. Participants will be contacted by phone on Day 28 for follow-up safety assessments.

Conditions: Epilepsy, Molecular Mechanisms of Pharmalogical Action, Protective Agents
Being tested: TAK-935, [18F]MNI-792 (tracer)
Keywords: Drug therapy, Positron Emission Tomography, Brain enzyme occupancy, Cholesterol 24S-hydroxylase, CH24H
Medical subject headings: Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAK-935Drug
TAK-935 oral solution.
[18F]MNI-792 (tracer)Drug
[18F]MNI-792 injection.

Study groups in NCT02497235
Study group	Role	What they receive
TAK-935	Experimental	A single dose of TAK-935 600 milligram (mg), oral solution on Day 1 as a starting dose and up to 370 megabecquerel (MBq) (10 millicurie [mCi]) of [18F]MNI-792 with a mass of up to 5 microgram (mcg), injection intravenously (IV), prior to each PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose. Subsequent dose of TAK-935 oral solution and timing of PET imaging will be based on safety, tolerability and occupancy data from previous level participants. Receives: Drug: TAK-935; Drug: [18F]MNI-792 (tracer)

What is being measured

The primary outcome is the main question the study is designed to answer.

Cholesterol 24S-Hydroxylase (CH24H) Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 45 Minutes Post-TAK-935 Dose
CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: total volume of distribution [VT] (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - non-displaceable volume of distribution [VND]), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept. Data was reported only for TAK-935 600 mg because only first two participants were analyzed at 45 minutes post-TAK-935 dose.
Measured: 45 minutes post-TAK-935 dose
CH24H Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 2 Hours Post-TAK-935 Dose
CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: VT (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - VND), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept.
Measured: 2 hours post-TAK-935 dose
CH24H Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 10 Hours Post-TAK-935 Dose
CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: VT (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - VND), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept. Data was reported only for TAK-935 600 mg because only first two participants were analyzed at 10 hour post-TAK-935 dose.
Measured: 10 hours post-TAK-935 dose
CH24H Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 24 Hours Post-TAK-935 Dose
CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: VT (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - VND), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept.
Measured: 24 hours post-TAK-935 dose

Secondary outcomes (2)

Plasma Concentration of TAK-935 During Post-TAK-935 Dosing PET Scan Periods
Measured: At time 0 (just after tracer injection), 1 hour after tracer injection and 2 hours after tracer injection for each post-TAK-935 dosing PET scan period
Percent Change From Baseline in the AUEC24 for Plasma 24S Hydroxycholesterol (24HC)
Percent change was calculated as = [(Postdose AUEC24(2) - Baseline AUEC24(2))/Baseline AUEC24(2)]*100 percent.
Measured: Baseline (Day -1): 1 hour and at multiple timepoints (up to 12 hours) post check in and Day 1: pre-dose and at multiple timepoints (up to 24 hours) post-TAK-935 dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015Jan 2016

First posted14 Jul 2015 (estimated)
Study startJul 2015
Primary completionDec 2015
Study completionJan 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Epilepsy, Molecular Mechanisms of Pharmalogical Action, Protective AgentsStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02497235
Sponsor's protocol ID: TAK-935_1003
Other IDs: U1111-1170-0452
Status last verified: Aug 2026
First submitted: 9 Jul 2015
Last updated: 15 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Constantinescu CC, Brown T, Wang S, Yin W, Barret O, Jennings D, Tauscher J. Clinical Characterization of [18F]T-008, a Cholesterol 24-Hydroxylase PET Ligand: Dosimetry, Kinetic Modeling, Variability, and Soticlestat Occupancy. J Nucl Med. 2023 Dec 1;64(12):1972-1979. doi: 10.2967/jnumed.123.265912.
PubMed 37770111

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Positron Emission Tomography, Phase 1 Study With [18F]MNI-792 to Determine Cholesterol 24S-Hydroxylase Target Occupancy of TAK-935 After Single-Dose Oral Administration in Healthy Subjects.
ClinicalTrials.gov ID: NCT02497235
Acronym / sponsor ID: TAK-935_1003
Conditions: Epilepsy, Molecular Mechanisms of Pharmalogical Action, Protective Agents
Keywords: Drug therapy, Positron Emission Tomography, Brain enzyme occupancy, Cholesterol 24S-hydroxylase, CH24H
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Jul 2015
Primary completion: Dec 2015 (actual)
Study completion: Jan 2016 (actual)
First posted: 14 Jul 2015 (estimated)
Results: Posted 11 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TAK-935	Experimental	Drug: TAK-935, Drug: [18F]MNI-792 (tracer)A single dose of TAK-935 600 milligram (mg), oral solution on Day 1 as a starting dose and up to 370 megabecquerel (MBq) (10 millicurie [mCi]) of [18F]MNI-792 with a mass of up to 5 microgram (mcg), injection intravenously (IV), prior to each PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose. Subsequent dose of TAK-935 oral solution and timing of PET imaging will be based on safety, tolerability and occupancy data from previous level participants.

Who may qualify

Ages: 19 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

In the opinion of the investigator, is capable of understanding and complying with protocol requirements.
Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.
Is a healthy male or female and aged 19 to 55 years, inclusive, at the time of informed consent and first study medication dose.
Weighs at least 45 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m^2), inclusive at Screening.
A female of non-bearing potential (example post-menopausal by history; or history of hysterectomy, bilateral salpingectomy, or oophorectomy).

Key exclusion criteria (6 listed)

Have a known history or evidence of a clinically significant disorder (including neurologic and psychiatric), or disease that in the opinion of the study investigator would pose a risk to the participant safety or interfere with the study evaluation, procedures or completion.
Contraindication to magnetic resonance imaging (MRI) based on the standard MRI radiography screening questionnaire.
Had exposure to any radiation greater than (>) 15 millisievert (mSv)/year (example, occupational or radiation therapy) within the previous year prior to Baseline imaging.
Has a known hypersensitivity to any component of the formulation of TAK-935 or related compounds, or to [18F]MNI-792 or to any of its components.
Clinically significant abnormal findings on brain MRI scan or findings on brain MRI that may interfere with the interpretation of the PET imaging.

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
TAK-935TAK-935 oral solution.	Drug	TAK-935
[18F]MNI-792 (tracer)[18F]MNI-792 injection.	Drug	TAK-935

Primary outcome

Cholesterol 24S-Hydroxylase (CH24H) Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 45 Minutes Post-TAK-935 Dose
Time frame: 45 minutes post-TAK-935 dose
CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: total volume of distribution [VT] (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - non-displaceable volume of distribution [VND]), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept. Data was reported only for TAK-935 600 mg because only first two participants were analyzed at 45 minutes post-TAK-935 dose.
CH24H Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 2 Hours Post-TAK-935 Dose
Time frame: 2 hours post-TAK-935 dose
CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: VT (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - VND), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept.
CH24H Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 10 Hours Post-TAK-935 Dose
Time frame: 10 hours post-TAK-935 dose
CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: VT (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - VND), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept. Data was reported only for TAK-935 600 mg because only first two participants were analyzed at 10 hour post-TAK-935 dose.
CH24H Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 24 Hours Post-TAK-935 Dose
Time frame: 24 hours post-TAK-935 dose
CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: VT (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - VND), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept.

2 secondary outcomes

Plasma Concentration of TAK-935 During Post-TAK-935 Dosing PET Scan Periods
Time frame: At time 0 (just after tracer injection), 1 hour after tracer injection and 2 hours after tracer injection for each post-TAK-935 dosing PET scan period
Percent Change From Baseline in the AUEC24 for Plasma 24S Hydroxycholesterol (24HC)
Time frame: Baseline (Day -1): 1 hour and at multiple timepoints (up to 12 hours) post check in and Day 1: pre-dose and at multiple timepoints (up to 24 hours) post-TAK-935 dose

Results and safety

Results posted to the registry on 11 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAK-935 50 mg	2	2
TAK-935 100 mg	2	2
TAK-935 200 mg	2	2
TAK-935 300 mg	2	2
TAK-935 600 mg	3	3

Primary outcome: Cholesterol 24S-Hydroxylase (CH24H) Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 45 Minutes Post-TAK-935 Dose

Time frame: 45 minutes post-TAK-935 dose. Number. Unit: percentage of occupancy

Measure	TAK-935 600 mg n = 2
Participant 1	NA
Participant 2	98
Participant 3	NA

Population analysed: PET target occupancy set where 45 minutes post-TAK-935-dose assessment were available. PET target occupancy set included all participants who received study drug (TAK-935) and had a technically adequate Baseline PET scan and at least 1 technically adequate post-TAK-935 dose PET scan.

Primary outcome: CH24H Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 2 Hours Post-TAK-935 Dose

Time frame: 2 hours post-TAK-935 dose. Number. Unit: percentage of occupancy

Measure	TAK-935 50 mg n = 2	TAK-935 100 mg n = 2	TAK-935 200 mg n = 2	TAK-935 300 mg n = 2	TAK-935 600 mg n = 1
Participant 1	70	79	96	91	NA
Participant 2	64	85	89	89	NA
Participant 3	NA	NA	NA	NA	96

Population analysed: PET target occupancy set where 2 hour post-TAK-935-dose assessment were available. PET target occupancy set included all participants who received study drug (TAK-935) and had a technically adequate Baseline PET scan and at least 1 technically adequate post-TAK-935 dose PET scan.

Primary outcome: CH24H Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 10 Hours Post-TAK-935 Dose

Time frame: 10 hours post-TAK-935 dose. Number. Unit: percentage of occupancy

Measure	TAK-935 600 mg n = 2
Participant 1	92
Participant 2	87
Participant 3	NA

Population analysed: PET target occupancy set where 10 hour post-TAK-935-dose assessment were available. PET target occupancy set included all participants who received study drug (TAK-935) and had a technically adequate Baseline PET scan and at least 1 technically adequate post-TAK-935 dose PET scan.

Primary outcome: CH24H Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 24 Hours Post-TAK-935 Dose

Time frame: 24 hours post-TAK-935 dose. Number. Unit: percentage of occupancy

Measure	TAK-935 50 mg n = 2	TAK-935 100 mg n = 2	TAK-935 200 mg n = 2	TAK-935 300 mg n = 2	TAK-935 600 mg n = 1
Participant 1	22	13	79	46	NA
Participant 2	11	NA	47	27	NA
Participant 3	NA	NA	NA	NA	52

Population analysed: PET target occupancy set where 24 hour post-TAK-935-dose assessment were available. PET target occupancy set included all participants who received study drug (TAK-935) and had a technically adequate Baseline PET scan and at least 1 technically adequate post-TAK-935 dose PET scan.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Day 28. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Baseline [18F]MNI-792	0 of 11 (0%)	1 of 11 (9.1%)	Not reported
TAK-935 50 mg	0 of 2 (0%)	1 of 2 (50%)	Not reported
TAK-935 100 mg	0 of 2 (0%)	1 of 2 (50%)	Not reported
TAK-935 200 mg	0 of 2 (0%)	1 of 2 (50%)	Not reported
TAK-935 300 mg	0 of 2 (0%)	1 of 2 (50%)	Not reported
TAK-935 600 mg	0 of 3 (0%)	1 of 3 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37770111Constantinescu CC, Brown T, Wang S, Yin W, Barret O, Jennings D, Tauscher J. Clinical Characterization of [18F]T-008, a Cholesterol 24-Hydroxylase PET Ligand: Dosimetry, Kinetic Modeling, Variability, and Soticlestat Occupancy. J Nucl Med. 2023 Dec 1;64(12):1972-1979. doi: 10.2967/jnumed.123.265912.

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.

Medical Director study director

Takeda (Note: This product was divested to Mistrau Bio, Inc. in 2026)

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 TAK-935 and [18F]MNI-792 (tracer) in people with Epilepsy, Molecular Mechanisms of Pharmalogical Action, Protective Agents, run by Takeda 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 5 inclusion and 6 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 15 Sep 2026. 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?

Yes. Results are posted in the registry (first posted 11 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cholesterol 24S-Hydroxylase (CH24H) Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 45 Minutes Post-TAK-935 Dose (time frame: 45 minutes post-TAK-935 dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02497235, which also lists 1 linked publication.

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 15 Sep 2026.