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

Attention-Deficit/Hyperactivity Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02163915
• Other study ID #: TAK-137_102
• Secondary ID: U1111-1152-6846
• Status: Terminated
• Phase: Phase 1
• First received: June 12, 2014
• Last updated: April 3, 2015
• Start date: June 2014
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• TAK-137
TAK-137 tablets
• TAK-137 Placebo
TAK-137 placebo-matching tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who experience at least one treatment-emergent adverse event (TEAE) after 7 days of dosing	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.	Day 1 to Day 14	Yes
Primary	Percentage of participants with markedly abnormal safety laboratory tests	The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period.	Day 1 to Day 8	Yes
Primary	Percentage of participants with markedly abnormal vital sign measurements	The percentage of participants who meet markedly abnormal criteria for vital signs, including systolic and diastolic blood pressure, heart rate, and oral temperature.	Day 1 to Day 8	Yes
Primary	Percentage of participants with markedly abnormal criteria for safety electrocardiogram (ECG) parameters	The percentage of participants who meet markedly abnormal criteria for safety electrocardiograms.	Day 1 to Day 8	Yes
Secondary	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.	Days 1 and 7	No
Secondary	Cmax,ss: Maximum Observed Plasma Concentration at Steady State for TAK-137	Maximum observed steady-state plasma concentration during a dosing interval.	Day 7	No
Secondary	Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137	Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.	Days 1 and 7	No
Secondary	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.	Days 1 and 7	No