The purpose of this study is to assess the mass balance and to characterize the pharmacokinetics (PK) in plasma and urine, and of total radioactivity in plasma and whole blood following a single oral dose of \[14C\]-TAK-659 solution containing 60 to 80 micro curie (Ci) of total radioactivity in participants with advanced solid tumors and/or lymphomas.
The drug being tested in this study is called TAK-659. TAK-659 is being tested to treat people who have advanced solid tumor and/or lymphoma malignancies. This study will look at the quantitative characterization of the mass balance, metabolic pathways, and rates and routes of excretion of TAK-659. The study will enroll approximately 6 participants. The study will consist of 2 periods: absorption, distribution, metabolism, and excretion (ADME) study period and optional post-ADME study period. In ADME study period, participants will be assigned with \[14C\]-TAK-659 100 milligram (mg). After completion of ADME study period, participants may choose to continue in the optional post-ADME study period to receive TAK-659 100 mg. This single center trial will be conducted in Netherlands. The overall time to participate in ADME study period will be 14 days and if participants choose the option to continue in the post-ADME study period, the maximum duration of participation will be 12 months, unless in the opinion of the investigator and sponsor the participant would derive benefit from continued treatment beyond 12 months. Participants will be followed up to 28 days after last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
\[14C\]-TAK-659 solution.
TAK-659 tablets.
Cmax: Maximum Observed Plasma Concentration for TAK-659
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Cmax: Maximum Observed Plasma and Whole Blood Radioactivity for [14C]-TAK-659
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-659
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Tmax: Time to Reach the Maximum Plasma and Whole Blood Radioactivity for [14C]-TAK-659
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for TAK-659
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
AUClast: Area Under the Plasma and Whole Blood Radioactivity-time Curve from Time 0 to the Time of the Last Quantifiable Radioactivity for [14C]-TAK-659
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Ae urine,14C: Cumulative Amount of Radioactivity Excreted in Urine for [14C]-TAK-659
Time frame: Baseline up to 14 days
Ae feces, 14C: Cumulative Amount of Radioactivity Excreted in Feces for [14C]-TAK-659
Time frame: Baseline up to 14 days
Ae total: Total Cumulative Amount of Radioactivity Excreted in Urine and Feces for [14C]-TAK-659
Time frame: Baseline up to 14 days
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Ae urine: Cumulative Amount of TAK-659 Excreted in Urine
Time frame: Baseline up to 14 days
Percentage of Dose Excreted in Urine for TAK-659
Time frame: Baseline up to 14 days
Renal Clearance (CLR) of TAK-659
Time frame: Baseline up to 14 days
Percentage of TAK-659 Metabolites in Plasma
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 28 days after the last dose of study drug (Week 58)
Percentage of Participants with Grade 3 or Higher Adverse Events (AEs)
Time frame: Baseline up to 28 days after the last dose of study drug (Week 58)
Percentage of Participants with Drug Related AEs
Time frame: Baseline up to 28 days after the last dose of study drug (Week 58)
Percentage of Participants with Drug Related Grade 3 or Higher AEs
Time frame: Baseline up to 28 days after the last dose of study drug (Week 58)
Percentage of Participants with AEs Leading to Discontinuation of TAK-659
Time frame: Baseline up to 28 days after the last dose of study drug (Week 58)
Percentage of Participants who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Time frame: Baseline up to 28 days after the last dose of study drug (Week 58)
Percentage of Participants who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Time frame: Baseline up to 28 days after the last dose of study drug (Week 58)
Percentage of TAK-659 Metabolites in Urine and Feces
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose