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Trial record 1 of 1 for:    TAK-137_102
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Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of TAK-137 in Adults With Attention-Deficit/Hyperactivity Disorder.

This study has been terminated.
(To allow evaluation of emerging non-clinical data (see detailed description below))
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02163915
First received: June 12, 2014
Last updated: June 1, 2016
Last verified: June 2016
  Purpose
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).

Condition Intervention Phase
Attention-Deficit/Hyperactivity Disorder Drug: TAK-137 Drug: TAK-137 Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Multiple Rising Doses of TAK-137 in Adult Subjects With Attention-Deficit/Hyperactivity Disorder

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) [ Time Frame: Day 1 up to Day 14 ]
    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.

  • 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 Outcome Measures:
  • Cmax: Maximum Observed Plasma Concentration for TAK-137 [ Time Frame: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose ]
    Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

  • Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-137 [ Time Frame: Day 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose ]
    Maximum observed steady-state plasma concentration during a dosing interval.

  • Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137 [ Time Frame: Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose ]
    Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.

  • AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-137 [ Time Frame: Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose ]
    Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.


Enrollment: 47
Study Start Date: June 2014
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1: TAK-137 0.5 mg
TAK-137 0.5 mg, tablets, orally once on Days 1-7.
Drug: TAK-137
TAK-137 tablets
Experimental: Cohort 2: TAK-137 2 mg
TAK-137 2 mg, tablets, orally once on Days 1-7.
Drug: TAK-137
TAK-137 tablets
Experimental: Cohort 3: TAK-137 5 mg
TAK-137 5 mg, tablets, orally once on Days 1-7.
Drug: TAK-137
TAK-137 tablets
Experimental: Cohort 4: TAK-137 10 mg
TAK-137 10 mg, tablets, orally once on Days 1-7.
Drug: TAK-137
TAK-137 tablets
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
TAK-137 tablets
Experimental: Cohorts 1-5: Placebo
TAK-137 placebo-matching tablets, orally, once on Days 1-7.
Drug: TAK-137 Placebo
TAK-137 placebo-matching tablets

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Is a male or female adult who is 18 to 55 years of age, inclusive.
  2. Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30.0 kg/m^2, inclusive at Screening.
  3. Has a documented diagnosis of attention-deficit/hyperactivity disorder (ADHD) for a minimum of 1 year.
  4. 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:

  1. Has received any investigational compound within 30 days prior to the first dose of study medication.
  2. 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.
  3. Has previously had a seizure or convulsion (lifetime), including absence seizure and febrile convulsion.
  4. 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).
  5. Has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products.
  6. 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.
  7. 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02163915

Locations
United States, New York
Marlton, New York, United States, 08053
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Clinical Science Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02163915     History of Changes
Other Study ID Numbers: TAK-137_102
U1111-1152-6846 ( Other Identifier: World Health Organization )
Study First Received: June 12, 2014
Results First Received: March 4, 2016
Last Updated: June 1, 2016

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2017