Back to resultsSafety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of TAK-137 in Adults With Attention-Deficit/Hyperactivity Disorder.
Primary Purpose
Attention-Deficit/Hyperactivity Disorder
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TAK-137
TAK-137 Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder focused on measuring Drug therapy
Eligibility Criteria
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:
- 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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
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
Cohort 5: TAK-137 TBD
Cohorts 1-5: Placebo
Arm Description
TAK-137 0.5 mg, tablets, orally once on Days 1-7.
TAK-137 2 mg, tablets, orally once on Days 1-7.
TAK-137 5 mg, tablets, orally once on Days 1-7.
TAK-137 10 mg, tablets, orally once on Days 1-7.
TAK-137, tablets, orally once on Days 1-7. Dose to be determined from data collected in Cohorts 1-3.
TAK-137 placebo-matching tablets, orally, once on Days 1-7.
Outcomes
Primary Outcome Measures
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.
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Pulse Measurements at Least Once Post Dose
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Blood Pressure Measurements at Least Once Post Dose
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Heart Rate Measurements at Least Once Post Dose
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
Secondary Outcome Measures
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.
Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-137
Maximum observed steady-state plasma concentration during a dosing interval.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02163915
Brief Title
Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of TAK-137 in Adults With Attention-Deficit/Hyperactivity Disorder.
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
To allow evaluation of emerging non-clinical data (see detailed description below)
Study Start Date
June 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit/Hyperactivity Disorder
Keywords
Drug therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: TAK-137 0.5 mg
Arm Type
Experimental
Arm Description
TAK-137 0.5 mg, tablets, orally once on Days 1-7.
Arm Title
Cohort 2: TAK-137 2 mg
Arm Type
Experimental
Arm Description
TAK-137 2 mg, tablets, orally once on Days 1-7.
Arm Title
Cohort 3: TAK-137 5 mg
Arm Type
Experimental
Arm Description
TAK-137 5 mg, tablets, orally once on Days 1-7.
Arm Title
Cohort 4: TAK-137 10 mg
Arm Type
Experimental
Arm Description
TAK-137 10 mg, tablets, orally once on Days 1-7.
Arm Title
Cohort 5: TAK-137 TBD
Arm Type
Experimental
Arm Description
TAK-137, tablets, orally once on Days 1-7. Dose to be determined from data collected in Cohorts 1-3.
Arm Title
Cohorts 1-5: Placebo
Arm Type
Experimental
Arm Description
TAK-137 placebo-matching tablets, orally, once on Days 1-7.
Intervention Type
Drug
Intervention Name(s)
TAK-137
Intervention Description
TAK-137 tablets
Intervention Type
Drug
Intervention Name(s)
TAK-137 Placebo
Intervention Description
TAK-137 placebo-matching tablets
Primary Outcome Measure Information:
Title
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Description
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
Title
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
Title
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
Title
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
Title
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
Title
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 Measure Information:
Title
Cmax: Maximum Observed Plasma Concentration for TAK-137
Description
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
Title
Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-137
Description
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
Title
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137
Description
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
Title
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-137
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director Clinical Science
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Marlton
State/Province
New York
ZIP/Postal Code
08053
Country
United States
12. IPD Sharing Statement
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Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of TAK-137 in Adults With Attention-Deficit/Hyperactivity Disorder.
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