Healthy VolunteersPhase 1NCT02201056

Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935

A Phase 1 study testing TAK-935 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.

Trial summary

The purpose of this study is to characterize the safety and tolerability profile of TAK-935 in healthy participants when administered as a single dose of oral solution at escalating dose levels. Read more about this study

Who is it for?: Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: TAK-935
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteUnited States
Study dates: Jul 2014to Jul 2015
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

Is a healthy male or female adult who is 19 to 55 years of age inclusive at the time of informed consent.
Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive at the Screening Visit.

Who cannot join

Has uncontrolled, clinically significant neurological (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunologic, endocrine disease, or psychiatric disorder, or other abnormality.
Has a known hypersensitivity to any component of the formulation of TAK-935.
There is any finding in the participant's medical history, significant results from physical examination, or safety laboratory tests.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Lincoln, Nebraska

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single Doses of TAK-935 in Healthy Subjects

The purpose of this study is to characterize the safety and tolerability profile of TAK-935 in healthy participants when administered as a single dose of oral solution at escalating dose levels.

Read the detailed description

The drug being tested in this study is TAK-935. TAK-935 is being tested to find a safe and well-tolerated dose and to assess how TAK-935 is processed by the body. This study will look at side effects and lab results in people who take TAK-935 and is designed as a randomized dose-rising study.

The study will consist of 6 Cohorts with 8 participants in each Cohort. In each Cohort, 6 participants will receive a single dose of TAK-935 and 2 participants will receive placebo after a 10-hour fast. The starting dose will be 15 mg followed by planned doses of 50, 200, 600, 900 and not to exceed 1350 mg in subsequent cohorts.

This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 51 days. Participants will make 2 visits to the clinic, including one 7-day period of confinement to the clinic. All participants will be contacted by telephone 14 days after the dose of study drug for a follow-up assessment.

Conditions: Healthy Volunteers
Being tested: TAK-935, Placebo
Keywords: Drug Therapy

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
PlaceboDrug
TAK-935 placebo-matching oral solution

Study groups in NCT02201056
Study group	Role	What they receive
Cohort 1: TAK-935 15 mg	Experimental	TAK-935 15 mg solution, orally, once, on Day 1. Receives: Drug: TAK-935
Cohort 2: TAK-935 50 mg	Experimental	TAK-935 50 mg solution, orally, once, on Day 1. Receives: Drug: TAK-935
Cohort 3: TAK-935 200 mg	Experimental	TAK-935 200 mg solution, orally, once, on Day 1. Receives: Drug: TAK-935
Cohort 4: TAK-935 600 mg	Experimental	TAK-935 600 mg solution, orally, once, on Day 1. Receives: Drug: TAK-935
Cohort 5: TAK-935 900 mg	Experimental	TAK-935 900 mg solution, orally, once, on Day 1. Receives: Drug: TAK-935
Cohort 6: TAK-935 1350 mg	Experimental	TAK-935 1350 mg solution, orally, once, on Day 1. Receives: Drug: TAK-935
Cohorts 1-6: Placebo	Placebo comparator	TAK-935 placebo-matching solution, orally, once, on Day 1. Receives: Drug: Placebo

What is being measured

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

Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after the last dose of study drug.
Measured: Day 1 to Day 30
Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose
The percentage of participants with any markedly abnormal standard safety laboratory values (hematology, serum chemistries, and urinalysis) collected during the treatment period.
Measured: Day 1 to Day 14
Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose
The percentage of participants with any markedly abnormal vital signs (oral temperature, respiration rate, pulse, and blood pressure) collected during the treatment period.
Measured: Day 1 to Day 14
Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose
The percentage of participants with any markedly abnormal criteria for standard 12-lead ECG measured collected during the treatment period.
Measured: Day 1 to Day 14

Secondary outcomes (3)

Cmax: Maximum Observed Plasma Concentration for TAK-935
Measured: Multiple time-points (Up to 96 hours) post-dose
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935
Measured: Multiple time-points (Up to 96 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935
Measured: Multiple time-points (Up to 96 hours) post-dose

Timeline

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

Jul 2014Jul 2015

First posted25 Jul 2014 (estimated)
Study startJul 2014
Primary completionJul 2015
Study completionJul 2015

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02201056
Sponsor's protocol ID: TAK-935_101
Other IDs: U111-1155-6022
Status last verified: Aug 2026
First submitted: 23 Jul 2014
Last updated: 15 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single Doses of TAK-935 in Healthy Subjects
ClinicalTrials.gov ID: NCT02201056
Acronym / sponsor ID: TAK-935_101
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 25 Jul 2014 (estimated)
Results: Posted 12 Jul 2016

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 characterize the safety and tolerability profile of TAK-935 in healthy participants when administered as a single dose of oral solution at escalating dose levels.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
Cohort 1: TAK-935 15 mg	Experimental	Drug: TAK-935TAK-935 15 mg solution, orally, once, on Day 1.
Cohort 2: TAK-935 50 mg	Experimental	Drug: TAK-935TAK-935 50 mg solution, orally, once, on Day 1.
Cohort 3: TAK-935 200 mg	Experimental	Drug: TAK-935TAK-935 200 mg solution, orally, once, on Day 1.
Cohort 4: TAK-935 600 mg	Experimental	Drug: TAK-935TAK-935 600 mg solution, orally, once, on Day 1.
Cohort 5: TAK-935 900 mg	Experimental	Drug: TAK-935TAK-935 900 mg solution, orally, once, on Day 1.
Cohort 6: TAK-935 1350 mg	Experimental	Drug: TAK-935TAK-935 1350 mg solution, orally, once, on Day 1.
Cohorts 1-6: Placebo	Placebo comparator	Drug: PlaceboTAK-935 placebo-matching solution, orally, once, on Day 1.

Who may qualify

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

Key inclusion criteria (2 listed)

Is a healthy male or female adult who is 19 to 55 years of age inclusive at the time of informed consent.
Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive at the Screening Visit.

Key exclusion criteria (3 listed)

Has uncontrolled, clinically significant neurological (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunologic, endocrine disease, or psychiatric disorder, or other abnormality.
Has a known hypersensitivity to any component of the formulation of TAK-935.
There is any finding in the participant's medical history, significant results from physical examination, or safety laboratory tests.

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	Cohort 1: TAK-935 15 mg, Cohort 2: TAK-935 50 mg, Cohort 3: TAK-935 200 mg, Cohort 4: TAK-935 600 mg, Cohort 5: TAK-935 900 mg, Cohort 6: TAK-935 1350 mg
PlaceboTAK-935 placebo-matching oral solution	Drug	Cohorts 1-6: Placebo

Primary outcome

Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: Day 1 to Day 30
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after the last dose of study drug.
Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose
Time frame: Day 1 to Day 14
The percentage of participants with any markedly abnormal standard safety laboratory values (hematology, serum chemistries, and urinalysis) collected during the treatment period.
Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose
Time frame: Day 1 to Day 14
The percentage of participants with any markedly abnormal vital signs (oral temperature, respiration rate, pulse, and blood pressure) collected during the treatment period.
Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose
Time frame: Day 1 to Day 14
The percentage of participants with any markedly abnormal criteria for standard 12-lead ECG measured collected during the treatment period.

3 secondary outcomes

Cmax: Maximum Observed Plasma Concentration for TAK-935
Time frame: Multiple time-points (Up to 96 hours) post-dose
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935
Time frame: Multiple time-points (Up to 96 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935
Time frame: Multiple time-points (Up to 96 hours) post-dose

Results and safety

Results posted to the registry on 12 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohorts 1-6: Placebo	12	12
Cohort 1: TAK-935 15 mg	6	6
Cohort 2: TAK-935 50 mg	6	6
Cohort 3: TAK-935 200 mg	6	6
Cohort 4: TAK-935 600 mg	6	6
Cohort 5: TAK-935 900 mg	6	6
Cohort 6: TAK-935 1350 mg	6	6

Primary outcome: Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)

Time frame: Day 1 to Day 30. Number. Unit: percentage of participants

Measure	Cohorts 1-6: Placebo n = 12	Cohort 1: TAK-935 15 mg n = 6	Cohort 2: TAK-935 50 mg n = 6	Cohort 3: TAK-935 200 mg n = 6	Cohort 4: TAK-935 600 mg n = 6	Cohort 5: TAK-935 900 mg n = 6	Cohort 6: TAK-935 1350 mg n = 6
Value	41.7	33.3	16.7	33.3	83.3	33.3	33.3

Population analysed: Safety set included all participants who were enrolled and received study drug.

Primary outcome: Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose

Time frame: Day 1 to Day 14. Number. Unit: percentage of participants

Measure	Cohorts 1-6: Placebo n = 12	Cohort 1: TAK-935 15 mg n = 6	Cohort 2: TAK-935 50 mg n = 6	Cohort 3: TAK-935 200 mg n = 6	Cohort 4: TAK-935 600 mg n = 6	Cohort 5: TAK-935 900 mg n = 6	Cohort 6: TAK-935 1350 mg n = 6
Value	16.7	0	0	0	0	16.7	0

Population analysed: Safety set included all participants who were enrolled and received study drug.

Primary outcome: Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose

Time frame: Day 1 to Day 14. Number. Unit: percentage of participants

Measure	Cohorts 1-6: Placebo n = 12	Cohort 1: TAK-935 15 mg n = 6	Cohort 2: TAK-935 50 mg n = 6	Cohort 3: TAK-935 200 mg n = 6	Cohort 4: TAK-935 600 mg n = 6	Cohort 5: TAK-935 900 mg n = 6	Cohort 6: TAK-935 1350 mg n = 6
Value	75.0	100	66.7	66.7	66.7	66.7	66.7

Population analysed: Safety set included all participants who were enrolled and received study drug.

Primary outcome: Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose

Time frame: Day 1 to Day 14. Number. Unit: percentage of participants

Measure	Cohorts 1-6: Placebo n = 12	Cohort 1: TAK-935 15 mg n = 6	Cohort 2: TAK-935 50 mg n = 6	Cohort 3: TAK-935 200 mg n = 6	Cohort 4: TAK-935 600 mg n = 6	Cohort 5: TAK-935 900 mg n = 6	Cohort 6: TAK-935 1350 mg n = 6
Value	25.0	66.7	83.3	50.0	16.7	33.3	33.3

Population analysed: Safety set included all participants who were enrolled and received study drug.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohorts 1-6: Placebo	0 of 12 (0%)	5 of 12 (41.7%)	Not reported
Cohort 1: TAK-935 15 mg	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Cohort 2: TAK-935 50 mg	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Cohort 3: TAK-935 200 mg	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Cohort 4: TAK-935 600 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Cohort 5: TAK-935 900 mg	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Cohort 6: TAK-935 1350 mg	0 of 6 (0%)	2 of 6 (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.

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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 Clinical Science 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 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 2 inclusion and 3 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. 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?

Yes. Results are posted in the registry (first posted 12 Jul 2016). 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?

Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) (time frame: Day 1 to Day 30). 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 NCT02201056.

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.