TerminatedNCT02163915Updated Jul 11, 2016Results posted

Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of TAK-137 in Adults With Attention-Deficit/Hyperactivity Disorder.

A Phase 1 interventional study of TAK-137 and TAK-137 Placebo in Attention-Deficit/Hyperactivity Disorder, sponsored by Takeda. Terminated at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2016-07-11.

Sponsored by Takeda · Phase 1, Interventional, and Treatment

Why this study was terminated

To allow evaluation of emerging non-clinical data (see detailed description below)

Phase: Phase 1
Study type: Interventional
Enrollment: 47
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

The purpose of this study is to characterize the safety and tolerability of TAK-137 when administered as multiple oral doses in adults with attention-deficit/hyperactivity disorder (ADHD).

Read the detailed description

The drug being tested in this study is called TAK-137. TAK-137 is being tested to find a safe and well-tolerated dose and to assess how TAK-137 is metabolized in people with attention-deficit/ hyperactivity disorder (ADHD). This study will look at side effects and lab results in people who take TAK-137. This study is designed as a randomized, sequential-cohort, multiple rising dose study.

Therefore, the TAK-137 2 mg Cohort will not start until the TAK-137 0.5 mg Cohort has completed, etc.

This trial will be conducted in the United States. The overall time to participate in this study is up to 42 days. Participants will make at least 2 visits to the clinic, including one 9-day period of confinement to the clinic. All participants will be contacted by telephone 7 days after the last dose of study drug for a follow-up assessment.

A decision was made to terminate this study so that emerging data from preclinical studies could be further assessed.

Conditions studied

Attention-Deficit/Hyperactivity Disorder

Browse trials for

Attention Deficit Disorder with Hyperactivity 1,547

Keywords

Drug therapy

In context

Attention Deficit Disorder with Hyperactivity

1,547 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 254 are open to participants now.

This study's enrollment of 47 is below the median of 71 across 1,233 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Takeda is the lead sponsor of 1,025 studies on the registry; 92 are open to participants now.

Of its 177 completed or terminated interventional studies of FDA-regulated products, 153 (86%) have results posted.

Browse Takeda studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Is a male or female adult who is 18 to 55 years of age, inclusive.
Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30.0 kg/m\^2, inclusive at Screening.
Has a documented diagnosis of attention-deficit/hyperactivity disorder (ADHD) for a minimum of 1 year.
Is willing to discontinue all medications to treat adult ADHD (eg, stimulants, antidepressants) and all other medications and dietary products as specified in the protocol, from Day -7 until Follow-up phone call (Day 14).

Exclusion criteria

Exclusion Criteria:

Has received any investigational compound within 30 days prior to the first dose of study medication.
Has uncontrolled, clinically significant neurologic (including mildly abnormal or significantly abnormal EEG at screening), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder (other than ADHD), or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
Has previously had a seizure or convulsion (lifetime), including absence seizure and febrile convulsion.
Has a positive urine drug result for drugs of abuse other than amphetamines or other medications to treat ADHD or positive result for alcohol at Screening or Check-in (Day -1).
Has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products.
Is pregnant or lactating or intending to become pregnant before, during, or within 12 weeks after participating in this study; or intending to donate ova during such time period.
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).

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 47 participants (actual)

Study arms

Experimental
Cohort 1: TAK-137 0.5 mg
TAK-137 0.5 mg, tablets, orally once on Days 1-7.
Drug: TAK-137
Experimental
Cohort 2: TAK-137 2 mg
TAK-137 2 mg, tablets, orally once on Days 1-7.
Drug: TAK-137
Experimental
Cohort 3: TAK-137 5 mg
TAK-137 5 mg, tablets, orally once on Days 1-7.
Drug: TAK-137
Experimental
Cohort 4: TAK-137 10 mg
TAK-137 10 mg, tablets, orally once on Days 1-7.
Drug: TAK-137
Experimental
Cohort 5: TAK-137 TBD
TAK-137, tablets, orally once on Days 1-7. Dose to be determined from data collected in Cohorts 1-3.
Drug: TAK-137
Experimental
Cohorts 1-5: Placebo
TAK-137 placebo-matching tablets, orally, once on Days 1-7.
Drug: TAK-137 Placebo

Interventions

DrugTAK-137
TAK-137 tablets
DrugTAK-137 Placebo
TAK-137 placebo-matching tablets

What researchers measure

Primary outcomes

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 (example, 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.
Time frame: Day 1 up to Day 14
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Time frame: Day 1 up to Day 8
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Pulse Measurements at Least Once Post Dose
Time frame: Day 1 up to Day 8
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Blood Pressure Measurements at Least Once Post Dose
Time frame: Day 1 up to Day 8
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Heart Rate Measurements at Least Once Post Dose
Time frame: Day 1 up to Day 8
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
Time frame: Day 1 up to Day 8

Secondary outcomes

Cmax: Maximum Observed Plasma Concentration for TAK-137
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time frame: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-137
Maximum observed steady-state plasma concentration during a dosing interval.
Time frame: Day 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Time frame: Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-137
Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.
Time frame: Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose

Results

Posted Jul 11, 2016

Participant flow

Participants took part in the study at 1 investigative site in the United States from 23 May 2014 to 03 November 2014.

Participant flow — Overall Study
Milestone	Cohorts 1-4: Placebo	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg
Started	10	8	10	9	10
Completed	7	8	8	6	6
Not completed	3	0	2	3	4
Withdrew: Withdrawal by subject	2	0	2	2	2
Withdrew: Study termination	1	0	0	0	2
Withdrew: Physician decision	0	0	0	1	0

Outcome measures

PrimaryPercentage 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 (example, 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.

Time frame:: Day 1 up to Day 14
Reported as:: Number · percentage of participants

Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
percentage of participants	Cohorts 1-4: Placebo	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)	50.0	62.5	0	66.7	20.0

PrimaryPercentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose

Time frame:: Day 1 up to Day 8
Reported as:: Number · percentage of participants

Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
percentage of participants	Cohorts 1-4: Placebo	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose	0	12.5	0	0	0

PrimaryPercentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Pulse Measurements at Least Once Post Dose

Time frame:: Day 1 up to Day 8
Reported as:: Number · percentage of participants

Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Pulse Measurements at Least Once Post Dose
percentage of participants	Cohorts 1-4: Placebo	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg
Supine, After 5 Minutes: < 50 bpm	50	37.5	50	22.2	40
Standing, After 1 Minute: < 50 bpm	10	0	0	11.1	0
Standing, After 1 Minute: > 120 bpm	10	0	10	0	40
Standing, After 3 Minutes: < 50 bpm	20	12.5	20	22.2	0
Standing, After 3 Minutes: > 120 bpm	30	0	10	0	50

PrimaryPercentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Blood Pressure Measurements at Least Once Post Dose

Time frame:: Day 1 up to Day 8
Reported as:: Number · percentage of participants

Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Blood Pressure Measurements at Least Once Post Dose
percentage of participants	Cohorts 1-4: Placebo	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg
SBP: Supine, After 5 Minutes: < 85 mmHg	10	0	0	11.1	10
SBP: Standing, After 3 Minutes: <85 mmHg	0	0	0	0	10
DBP: Supine, After 5 Minutes: <50 mmHg	30	25	10	44.4	0
DBP: Standing, After 1 Minute: <50 mmHg	30	0	10	22.2	0
DBP: Standing, After 1 Minute: >110 mmHg	0	0	0	0	10
DBP: Standing, After 3 Minutes: <50 mmHg	30	25	30	44.4	20
DBP: Standing, After 3 Minutes: >110 mmHg	0	0	0	11.1	10

PrimaryPercentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Heart Rate Measurements at Least Once Post Dose

Time frame:: Day 1 up to Day 8
Reported as:: Number · percentage of participants

Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Heart Rate Measurements at Least Once Post Dose
percentage of participants	Cohorts 1-4: Placebo	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Heart Rate Measurements at Least Once Post Dose	30	25	30	22.2	30

SecondaryCmax: Maximum Observed Plasma Concentration for TAK-137

Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

Time frame:: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Reported as:: Mean · nanogram per milliliter (ng/mL)

Cmax: Maximum Observed Plasma Concentration for TAK-137
nanogram per milliliter (ng/mL)	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg
Cmax: Maximum Observed Plasma Concentration for TAK-137	8.32 ± 2.651	28.04 ± 7.554	64.91 ± 24.592	103.13 ± 27.822

SecondaryCmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-137

Maximum observed steady-state plasma concentration during a dosing interval.

Time frame:: Day 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Reported as:: Mean · ng/mL

Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-137
ng/mL	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg
Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-137	7.79 ± 2.039	38.01 ± 22.749	86.25 ± 35.079	176.25 ± 113.096

SecondaryTmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137

Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.

Time frame:: Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Reported as:: Median · hours

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137
hours	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg
Day 1 (n= 8, 10, 8, 10)	1.560 ± 2.039	1.750 ± 22.749	2.060 ± 35.079	4.000 ± 113.096
Day 7 (n= 8, 8, 6, 6)	1.015 (1.00 to 2.00)	1.750 (1.00 to 4.00)	3.500 (2.00 to 4.00)	2.000 (1.00 to 3.00)

SecondaryAUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-137

Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.

Time frame:: Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Reported as:: Mean · nanogram hours per milliliter (ng*hr/mL)

AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-137
nanogram hours per milliliter (ng*hr/mL)	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg
Day 1 (n= 8, 10, 8, 10)	73.5 ± 37.87	265.3 ± 156.89	717.1 ± 432.37	1442.8 ± 621.57
Day 7 (n= 8, 8, 6, 4)	52.9 ± 24.15	438.4 ± 600.42	1224.0 ± 689.80	3288.5 ± 3189.13

PrimaryPercentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose

Time frame:: Day 1 up to Day 8
Reported as:: Number · percentage of participants

Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
percentage of participants	Cohorts 1-4: Placebo	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg
PR Interval: ≤80 msec	0	0	10	0	0
PR Interval: ≥200 msec	0	25	30	22.2	10
QRS Interval: ≤80 msec	10	0	20	22.2	20
QT Interval: ≥460 msec	0	0	10	0	0

Adverse events

Collected over Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohorts 1-4: Placebo	—	0/10 (0%)	5/10 (50%)
Cohort 1: TAK-137 0.5 mg	—	0/8 (0%)	5/8 (62.5%)
Cohort 2: TAK-137 2 mg	—	0/10 (0%)	0/10 (0%)
Cohort 3: TAK-137 5 mg	—	0/9 (0%)	6/9 (66.7%)
Cohort 4: TAK-137 10 mg	—	0/10 (0%)	2/10 (20%)

Most frequent other events

Showing 10 of 15

Most frequent other events
Event	Cohorts 1-4: Placebo	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg
Electroencephalogram abnormalInvestigations	0/10	3/8	0/10	0/9	0/10
DizzinessNervous system disorders	2/10	0/8	0/10	3/9	0/10
HeadacheNervous system disorders	1/10	2/8	0/10	1/9	0/10
NauseaGastrointestinal disorders	0/10	1/8	0/10	2/9	0/10
ArthralgiaMusculoskeletal and connective tissue disorders	0/10	0/8	0/10	2/9	1/10
Infusion site haematomaGeneral disorders	0/10	1/8	0/10	0/9	0/10
DyspepsiaGastrointestinal disorders	0/10	0/8	0/10	1/9	0/10
Heart rate decreasedInvestigations	1/10	0/8	0/10	1/9	0/10
Blood pressure diastolic decreasedInvestigations	0/10	0/8	0/10	1/9	0/10
DysuriaRenal and urinary disorders	0/10	0/8	0/10	1/9	0/10

Baseline characteristics

Safety analysis set was defined as all participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)	Cohorts 1-4: Placebo	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg	Total
Mean	28.1 ± 10.59	33.0 ± 9.65	28.6 ± 8.75	32.6 ± 10.73	31.6 ± 11.68	30.6 ± 10.10

Sex: Female, Male
Sex: Female, Male(Participants)	Cohorts 1-4: Placebo	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg	Total
Female	5	1	1	2	3	12
Male	5	7	9	7	7	35

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Cohorts 1-4: Placebo	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg	Total
Black or African American	5	2	6	4	7	24
Native Hawaiian or Other Pacific Islander	0	1	0	0	0	1
White	4	3	4	5	3	19
Multiracial	1	2	0	0	0	3

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Cohorts 1-4: Placebo	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg	Total
Hispanic or Latino	2	0	2	1	3	8
Non-Hispanic or Latino	8	8	8	8	7	39

Height
Height(centimeter (cm))	Cohorts 1-4: Placebo	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg	Total
Mean	171.8 ± 7.96	172.4 ± 9.07	171.7 ± 7.09	174.8 ± 7.36	172.4 ± 5.23	172.6 ± 7.13

Weight
Weight(kilogram (kg))	Cohorts 1-4: Placebo	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg	Total
Mean	77.42 ± 10.211	76.01 ± 14.537	75.11 ± 14.376	79.61 ± 9.205	74.73 ± 13.815	76.54 ± 12.777

Body Mass Index
Body Mass Index(kilogram per square meter (kg/m^2))	Cohorts 1-4: Placebo	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg	Total
Mean	26.25 ± 3.182	25.46 ± 3.408	25.36 ± 3.942	26.02 ± 2.204	25.09 ± 3.969	25.64 ± 3.303

Caffeine Consumption
Caffeine Consumption(participants)	Cohorts 1-4: Placebo	Cohort 1: TAK-137 0.5 mg	Cohort 2: TAK-137 2 mg	Cohort 3: TAK-137 5 mg	Cohort 4: TAK-137 10 mg	Total
Had caffeine consumption	7	5	6	7	4	29
Had no caffeine consumption	3	3	4	2	6	18

4 further baseline measures are reported on the registry.

Study locations

1 site

Marlton, New York 08053, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02163915
Lead sponsor: Takeda
Responsible party: Sponsor
First posted: Jun 16, 2014
Start date: Jun 2014
Primary completion: Nov 2014
Completion: Nov 2014
Results posted: Jul 11, 2016
Last update: Jul 11, 2016

Study contacts

Medical Director Clinical Science

study director · Takeda

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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