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

NCT02163915 | Terminated Phase 1 Results

• 2 other identifiers: TAK-137_102U1111-1152-6846
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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).

Conditions

Attention-Deficit/Hyperactivity Disorder

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (6)

• 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.

  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

  Day 1 up to Day 8

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

  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

  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

  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

  Day 1 up to Day 8

Secondary Outcomes (4)

• Cmax: Maximum Observed Plasma Concentration for TAK-137

  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

  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

  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

  Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose

Study Arms (6)

Cohort 1: TAK-137 0.5 mg

EXPERIMENTAL

TAK-137 0.5 mg, tablets, orally once on Days 1-7.

Drug: TAK-137

Cohort 2: TAK-137 2 mg

EXPERIMENTAL

TAK-137 2 mg, tablets, orally once on Days 1-7.

Drug: TAK-137

Cohort 3: TAK-137 5 mg

EXPERIMENTAL

TAK-137 5 mg, tablets, orally once on Days 1-7.

Drug: TAK-137

Cohort 4: TAK-137 10 mg

EXPERIMENTAL

TAK-137 10 mg, tablets, orally once on Days 1-7.

Drug: TAK-137

Cohort 5: TAK-137 TBD

EXPERIMENTAL

TAK-137, tablets, orally once on Days 1-7. Dose to be determined from data collected in Cohorts 1-3.

Drug: TAK-137

Cohorts 1-5: Placebo

EXPERIMENTAL

TAK-137 placebo-matching tablets, orally, once on Days 1-7.

Drug: TAK-137 Placebo

Interventions

TAK-137 DRUG

TAK-137 tablets

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

TAK-137 Placebo DRUG

TAK-137 placebo-matching tablets

Cohorts 1-5: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Marlton, New York, 08053, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

TAK-137

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 16, 2014
• Study Start: June 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 11, 2016
• Results First Posted: July 11, 2016

Record last verified: 2016-06

Locations

US (1)