Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy Japanese Adult Male

Outcome Measures

Primary Outcomes (14)

Frequencies of Adverse events (Single dose Part)
The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness, and causal relationship to TAK-137. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, reported from the first dose to the last dose of TAK-137.
Up to 8 days
Frequencies of Adverse events (Multiple dose Part)
The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness, and causal relationship to TAK-137. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, reported from the first dose to the last dose of TAK-137.
Up to 14 days
Descriptive statistics (mean, SD, median, minimum and maximum) of changes from baseline for vital sign measurements at least once post-dose (Single dose Part)
Up to 8 days
Descriptive statistics (mean, SD, median, minimum and maximum) of changes from baseline for vital sign measurements at least once post-dose (Multiple dose Part)
Up to 9 days
Descriptive statistics (mean, SD, median, minimum and maximum) of changes from baseline for body weight measurements at least once post-dose (Single dose Part)
Up to 8 days
Descriptive statistics (mean, SD, median, minimum and maximum) of changes from baseline for body weight measurements at least once post-dose (Multiple dose Part)
Up to 9 days
Percentage of participants with abnormal and clinically significant judged by investigator for electrocardiogram measurements at least once post-dose (Single dose Part)
The percentage of participants with abnormal and clinically significant judged by investigator, electrocardiogram measurements during the study period.
Up to 8 days
Percentage of participants with abnormal and clinically significant judged by investigator for electrocardiogram measurements at least once post-dose (Multiple dose Part)
The percentage of participants with abnormal and clinically significant judged by investigator, electrocardiogram measurements during the study period.
Up to 9 days
Percentage of participants with significantly abnormal (epileptiform) judged by investigator for electroencephalogram measurements at least once post-dose (Single dose Part)
The percentage of participants with significantly abnormal (epileptiform) judged by investigator, electroencephalogram measurements during the study period.
Up to 1 day
Percentage of participants with significantly abnormal (epileptiform) judged by investigator for electroencephalogram measurements at least once post-dose (Multiple dose Part)
The percentage of participants with significantly abnormal (epileptiform) judged by investigator, electroencephalogram measurements during the study period.
Up to 7 days
Percentage of participants who meet the markedly abnormal criteria for safety laboratory tests at least once post-dose (Single dose Part)
The percentage of participants with any markedly abnormal, standard safety laboratory values, including hematology and serum chemistries during the study period.
Up to 8 days
Percentage of participants who meet the markedly abnormal criteria for safety laboratory tests at least once post-dose (Multiple dose Part)
The percentage of participants with any markedly abnorma, standard safety laboratory values, including hematology and serum chemistries during the study period.
Up to 9 days
Descriptive statistics (mean, SD, median, minimum and maximum) of observed value for Stimulant relapse risk scale (excerpt) (Single dose Part)
Up to 8 days
Descriptive statistics (mean, SD, median, minimum and maximum) of observed value for Stimulant relapse risk scale (excerpt) (Multiple dose Part )
Up to 9 days

Secondary Outcomes (3)

Descriptive statistics (mean, SD, median, minimum and maximum) of pharmacokinetic parameters (AUC(0-168), AUC(0-tlqc), Cmax, Tmax, AUC(0-inf), T1/2, CL/F, Vz/F and MR) for unchanged TAK-137 and its metabolite M-I in plasma (Single dose Part)
Days 1-8
Descriptive statistics (mean, SD, median, min. and max.) of pharmacokinetic parameters for unchanged TAK-137 and its metabolite M-I in plasma (Multiple dose Part)
Days 1-9
Descriptive statistics (mean, SD, median, minimum and maximum) of pharmacokinetic parameters (Fe and CLr) for unchanged TAK-137 and its metabolite M-I in urine (Single dose Part)
Days 1-4 (Prior to administration and 0-24, 24-48, 48-72 hours after administration)

Study Arms (6)

Cohort 1: TAK-137 5 mg, TAK-137 placebo

OTHER

Single-dose administration in a fasting state

Drug: TAK-137 5 mg tablet, TAK-137 placebo tablet

Cohort 2: TAK-137 10 mg, TAK-137 placebo tablet

OTHER

Single-dose administration in a fasting state

Drug: TAK-137 5 mg tablet, TAK-137 placebo tablet

Cohort 3: TAK-137 20 mg or TAK-137 2 mg + TAK-137 placebo

OTHER

Single-dose administration in a fasting state

Drug: TAK-137 5 mg tablet, TAK-137 placebo tablet or TAK-137 0.5 mg tablet, TAK-137 placebo tablet

Interventions

TAK-137 5 mg tablet, TAK-137 placebo tabletDrug

Cohort 1: TAK-137 5 mg, TAK-137 placebo

TAK-137 5 mg tablet, TAK-137 placebo tabletDrug

Cohort 2: TAK-137 10 mg, TAK-137 placebo tablet

Eligibility Criteria

Age25 Years - 45 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Participant eligibility is determined according to the following criteria prior to entry into the study:
In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.

Sponsors & Collaborators

Takeda
Industrylead

Study Sites (1)

Kagoshima, Kagoshima-ken, Japan

MeSH Terms

Interventions

TAK-137Tablets

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

General Manager
Takeda
STUDY DIRECTOR

Enrollment

0 participants (actual enrollment reported by the registry).

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

October 28, 2014

First Posted

December 23, 2014

Study Start

November 2014

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Any participant who meets any of the following criteria will not qualify for entry into the study:
The participant has received any investigational drugs within 30 days prior to the first study drug administration.
The participant has received TAK-137 in a previous clinical study.
The participant is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.
The participant has previously had a seizure or convulsion (lifetime), including absence seizure and febrile convulsion
The participant has a history of psychiatric disorders.
The participant has a known hypersensitivity to medication(s) or food(s).
The participant has positive results in the urine drug screening test at screening.
The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the screening or is unwilling to agree to abstain from alcohol and drugs throughout the study period.
The participant has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products during the screening period, or requires such medication or food during the study.
The participant intends to donate sperm from the signing of ICF to 12 weeks after the last dose.
The participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent \[more than once per week\] occurrence of heartburn, or any surgical intervention, \[e.g. gastrectomy, cholecystectomy, etc.\]).
The subject has a history of cancer.
The subject has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, or serological reactions for syphilis at screening.
+9 more criteria

A Phase 1, Single and Multiple Dose Study of TAK-137

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (14)

Secondary Outcomes (3)

Study Arms (6)

Cohort 1: TAK-137 5 mg, TAK-137 placebo

Cohort 2: TAK-137 10 mg, TAK-137 placebo tablet

Cohort 3: TAK-137 20 mg or TAK-137 2 mg + TAK-137 placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Cohort 4: TAK-137 5mg, TAK-137 placebo

Cohort 5: TAK-137 10 mg, TAK-137 placebo

Cohort 6: TAK-137 15 mg, TAK-137 placebo

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (14)

Secondary Outcomes (3)

Study Arms (6)

Cohort 1: TAK-137 5 mg, TAK-137 placebo

Cohort 2: TAK-137 10 mg, TAK-137 placebo tablet

Cohort 3: TAK-137 20 mg or TAK-137 2 mg + TAK-137 placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Cohort 4: TAK-137 5mg, TAK-137 placebo

Cohort 5: TAK-137 10 mg, TAK-137 placebo

Cohort 6: TAK-137 15 mg, TAK-137 placebo

You may not qualify if:

Source record

Locations