Healthy VolunteersPhase 1NCT02906813

A Study to Determine the Bioavailability and Food Effect of a Single TAK-935 Dose in Healthy Participants

A Phase 1 study testing TAK-935 Tablets and TAK-935 Oral Solution in people with Healthy Volunteers, 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 assess the relative bioavailability (BA) of 300 milligram (mg) TAK-935 tablets compared to 300 mg of TAK-935 solution and to determine the effect of food on the BA of TAK-935 300 mg tablets in healthy adult participants. 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?: TAK-935 Tablets and TAK-935 Oral Solution
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 12 Sep 2016to 9 Nov 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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

1. 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 and Day -2.

Who cannot join

Has received TAK-935 in a previous clinical study or as a therapeutic agent.
Has a history of any psychiatric disorder as diagnosed utilizing Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria.
Has any lifetime history of drug abuse (defined as any illicit drug use) or any lifetime history of alcohol abuse prior to the screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. One unit is equivalent to a half-pint of beer or a single measure of spirits or 1 small glass of wine.
Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody at Screening or a known history of human immunodeficiency virus infection.
Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-In Day -1. Cotinine test is positive at Screening or Check-In (Day -1).
Has poor peripheral venous access.
Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1 of Period 1.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Glendale, California

Other trials in United States

About this study

Official title: A Phase 1 Bioavailability and Food Effect Study to Compare Tablet Versus Solution Formulation and to Assess the Effect of Food on the Bioavailability of a Single TAK-935 Dose in Healthy Subjects

Read the detailed description

The drug being tested in this study is called TAK-935. The study will look at the relative BA of TAK-935 300 mg tablets compared to a TAK-935 300 mg oral solution and will assess the effect of food on the BA of TAK-935 300 mg tablets in healthy adult participants.

The study will enroll approximately 9 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 3 treatment sequences:

TAK-935 (300 mg Tablets Fed + 300 mg Tablets Fasted + 300 mg Solution Fasted)
TAK-935 (300 mg Tablets Fasted + 300 mg Solution Fasted + 300 mg Tablets Fed)
TAK-935 (300 mg Solution Fasted + 300 mg Tablets Fed + 300 mg Tablets Fasted)

Administration of each dose will be separated by a washout period of at least 3 days. Participants will be asked to take single dose of TAK-935 tablet or oral solution on Day 1 of each Intervention Period.

This single center trial will be conducted in the United States. The overall time to participate in this study is 39 days. Participants will remain confined to the clinic from Day 1 of Intervention Period 1 to Day 3 of Intervention Period 3 and will be contacted by telephone 30 days after last dose of TAK-935 for a follow-up assessment.

Conditions: Healthy Volunteers
Being tested: TAK-935 Tablets, TAK-935 Oral Solution
Keywords: Drug Therapy

What participants receive

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

TAK-935 TabletsDrug
Tablets
TAK-935 Oral SolutionDrug
Oral solution

Study groups in NCT02906813
Study group	Role	What they receive
TAK-935 300 mg (Tablets Fed+Tablets Fasted+Solution Fasted)	Experimental	TAK-935 300 mg, tablets, orally, 30 minutes after a high-fat meal on Day 1 of Intervention Period 1, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg, tablets, orally, under fasted state on Day 1 of Intervention Period 2, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg, solution, orally, in fasted state on Day 1 of Intervention Period 3. Receives: Drug: TAK-935 Tablets; Drug: TAK-935 Oral Solution
TAK-935 300 mg (Tablets Fasted+Solution Fasted+Tablets Fed	Experimental	TAK-935 300 mg, tablets, orally under fasted state on Day 1 of Intervention Period 1, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg, solution, orally, in fasted state on Day 1 of Intervention Period 2, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg tablets, orally, 30 minutes after high-fat meal on Day 1 of Intervention Period 3. Receives: Drug: TAK-935 Tablets; Drug: TAK-935 Oral Solution
TAK-935 300 mg (Solution Fasted+Tablets Fed+Tablets Fasted)	Experimental	TAK-935 300 mg, solution, orally, in fasted state on Day 1 of Intervention Period 1, followed by washout period of at least 3 days, further followed by TAK-935 300 mg, tablets, orally, 30 minutes after a high-fat meal on Day 1 of Intervention Period 2, followed by washout period of at least 3 days, further followed by TAK-935 300 mg, tablets, orally, under fasted state on Day 1 of Intervention Period 3. Receives: Drug: TAK-935 Tablets; Drug: TAK-935 Oral Solution

What is being measured

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

Cmax: Maximum Observed Plasma Concentration for TAK-935
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

Secondary outcomes (4)

Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Measured: Baseline up to 30 days after last dose of study drug (Day 39)
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Measured: Baseline up to Day 11
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose.
Measured: Baseline up to Day 11
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
Measured: Baseline up to Day 11

Timeline

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

12 Sep 20169 Nov 2016

First posted20 Sep 2016 (estimated)
Study start12 Sep 2016
Primary completion12 Oct 2016
Study completion9 Nov 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.
Other trials for Healthy VolunteersStudies 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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02906813
Sponsor's protocol ID: TAK-935-1005
Other IDs: U1111-1177-8044
Status last verified: Aug 2026
First submitted: 15 Sep 2016
Last updated: 14 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Bioavailability and Food Effect Study to Compare Tablet Versus Solution Formulation and to Assess the Effect of Food on the Bioavailability of a Single TAK-935 Dose in Healthy Subjects
ClinicalTrials.gov ID: NCT02906813
Acronym / sponsor ID: TAK-935-1005
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 12 Sep 2016 (actual)
Primary completion: 12 Oct 2016 (actual)
Study completion: 9 Nov 2016 (actual)
First posted: 20 Sep 2016 (estimated)
Results: Posted 19 Sep 2018

Clinical summary

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

Detailed description

The study will enroll approximately 9 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 3 treatment sequences:

TAK-935 (300 mg Tablets Fed + 300 mg Tablets Fasted + 300 mg Solution Fasted)
TAK-935 (300 mg Tablets Fasted + 300 mg Solution Fasted + 300 mg Tablets Fed)
TAK-935 (300 mg Solution Fasted + 300 mg Tablets Fed + 300 mg Tablets Fasted)

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
TAK-935 300 mg (Tablets Fed+Tablets Fasted+Solution Fasted)	Experimental	Drug: TAK-935 Tablets, Drug: TAK-935 Oral SolutionTAK-935 300 mg, tablets, orally, 30 minutes after a high-fat meal on Day 1 of Intervention Period 1, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg, tablets, orally, under fasted state on Day 1 of Intervention Period 2, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg, solution, orally, in fasted state on Day 1 of Intervention Period 3.
TAK-935 300 mg (Tablets Fasted+Solution Fasted+Tablets Fed	Experimental	Drug: TAK-935 Tablets, Drug: TAK-935 Oral SolutionTAK-935 300 mg, tablets, orally under fasted state on Day 1 of Intervention Period 1, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg, solution, orally, in fasted state on Day 1 of Intervention Period 2, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg tablets, orally, 30 minutes after high-fat meal on Day 1 of Intervention Period 3.
TAK-935 300 mg (Solution Fasted+Tablets Fed+Tablets Fasted)	Experimental	Drug: TAK-935 Tablets, Drug: TAK-935 Oral SolutionTAK-935 300 mg, solution, orally, in fasted state on Day 1 of Intervention Period 1, followed by washout period of at least 3 days, further followed by TAK-935 300 mg, tablets, orally, 30 minutes after a high-fat meal on Day 1 of Intervention Period 2, followed by washout period of at least 3 days, further followed by TAK-935 300 mg, tablets, orally, under fasted state on Day 1 of Intervention Period 3.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

1. 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 and Day -2.

Key exclusion criteria (8 listed)

Has received TAK-935 in a previous clinical study or as a therapeutic agent.
Has a history of any psychiatric disorder as diagnosed utilizing Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria.
Has any lifetime history of drug abuse (defined as any illicit drug use) or any lifetime history of alcohol abuse prior to the screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. One unit is equivalent to a half-pint of beer or a single measure of spirits or 1 small glass of wine.
Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody at Screening or a known history of human immunodeficiency virus infection.

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-935 TabletsTablets	Drug	TAK-935 300 mg (Solution Fasted+Tablets Fed+Tablets Fasted), TAK-935 300 mg (Tablets Fasted+Solution Fasted+Tablets Fed, TAK-935 300 mg (Tablets Fed+Tablets Fasted+Solution Fasted)
TAK-935 Oral SolutionOral solution	Drug	TAK-935 300 mg (Solution Fasted+Tablets Fed+Tablets Fasted), TAK-935 300 mg (Tablets Fasted+Solution Fasted+Tablets Fed, TAK-935 300 mg (Tablets Fed+Tablets Fasted+Solution Fasted)

Primary outcome

Cmax: Maximum Observed Plasma Concentration for TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

4 secondary outcomes

Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Time frame: Baseline up to 30 days after last dose of study drug (Day 39)
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Time frame: Baseline up to Day 11
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose.
Time frame: Baseline up to Day 11
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
Time frame: Baseline up to Day 11

Results and safety

Results posted to the registry on 19 Sep 2018, 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-935 300 mg: Tablets Fed + Tablets Fasted + Solution Fasted	3	3
TAK-935 300 mg: Tablets Fasted + Solution Fasted + Tablets Fed	3	3
TAK 935 300 mg: Solution Fasted + Tablets Fed + Tablets Fasted	3	3

Primary outcome: Cmax: Maximum Observed Plasma Concentration for TAK-935

Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose. Mean (Standard Deviation). Unit: nanogram per milliliter (ng/mL)

Measure	TAK-935 300 mg Tablets Fed n = 9	TAK-935 300 mg Tablets Fasted n = 9	TAK-935 300 mg Solution Fasted n = 9
Value	477.000 (298.0705)	1150.889 (710.5940)	1882.000 (1250.7022)

TAK-935 300 mg Tablets Fasted vs TAK-935 300 mg Solution Fasted: Least Square (LS) Mean Ratio: 0.631 (90% CI 0.411 to 0.969), p = 0.079, ANOVA
TAK-935 300 mg Tablets Fed vs TAK-935 300 mg Tablets Fasted: LS Mean Ratio: 0.403 (90% CI 0.262 to 0.618), p = 0.002, ANOVA

Population analysed: The pharmacokinetic (PK) set included all participants who were enrolled, received study drug and had at least 1 measurable plasma concentration for either TAK-935 or its metabolite (M-I).

Primary outcome: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935

Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose. Mean (Standard Deviation). Unit: nanogram hours per milliliter (ng*hr/mL)

Measure	TAK-935 300 mg Tablets Fed n = 9	TAK-935 300 mg Tablets Fasted n = 9	TAK-935 300 mg Solution Fasted n = 9
Value	1170.954 (386.1425)	1328.482 (496.8168)	1601.806 (711.7143)

TAK-935 300 mg Tablets Fasted vs TAK-935 300 mg Solution Fasted: LS Mean Ratio: 0.850 (90% CI 0.706 to 1.024), p = 0.146, ANOVA
TAK-935 300 mg Tablets Fed vs TAK-935 300 mg Tablets Fasted: LS Mean Ratio: 0.889 (90% CI 0.738 to 1.070), p = 0.281, ANOVA

Population analysed: The PK set included all participants who were enrolled, received study drug and had at least 1 measurable plasma concentration for either TAK-935 or its M-I.

Primary outcome: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935

Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	TAK-935 300 mg Tablets Fed n = 9	TAK-935 300 mg Tablets Fasted n = 8	TAK-935 300 mg Solution Fasted n = 8
Value	1182.641 (385.6485)	1369.963 (523.2334)	1564.307 (743.3798)

TAK-935 300 mg Tablets Fasted vs TAK-935 300 mg Solution Fasted: LS Mean Ratio: 0.842 (90% CI 0.676 to 1.050), p = 0.191, ANOVA
TAK-935 300 mg Tablets Fed vs TAK-935 300 mg Tablets Fasted: LS Mean Ratio: 0.894 (90% CI 0.726 to 1.100), p = 0.355, ANOVA

Population analysed: The PK analysis set where data on Day 1 was available. The PK set included all participants who were enrolled, received study drug and had at least 1 measurable plasma concentration for either TAK-935 or its M-I.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 39) after the last dose of study drug. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAK-935 300 mg Tablets Fed	0 of 9 (0%)	0 of 9 (0%)	0 of 9
TAK-935 300 mg Tablets Fasted	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
TAK-935 300 mg Solution Fasted	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

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 Tablets and TAK-935 Oral Solution in people with Healthy Volunteers, 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 1 inclusion and 8 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 14 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 19 Sep 2018). 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?

Cmax: Maximum Observed Plasma Concentration for TAK-935 (time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose). The study lists 3 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 NCT02906813.

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 14 Sep 2026.