The aim of this study is to understand how TAK-994 is processed by the body. This study will require participants to stay at the clinical research unit for 3 weeks to be monitored after receiving TAK-994.
The drug being tested in this study is called TAK-994. TAK-994 is being tested in healthy male participants. This study will characterize how TAK -994 is absorbed, metabolize, excreted by the body, after single oral administration by collecting plasma, urine, and feces samples for testing. The study will enroll approximately 6 participants. The study consists of 2 parts: Part A and Part B. In Part A, all participants will receive TAK-994 as tablet and \[14C\]TAK-994 as intravenous infusion. In Part B, all participants will receive a single dose of \[14C\]TAK-994 as an oral suspension. This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 67 days, including a 28-day screening period plus approximately 30 days for follow up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
6
TAK-994 tablet.
\[14C\]TAK-994 intravenous infusion.
\[14C\]TAK-994 oral suspension.
Celerion
Lincoln, Nebraska, United States
Part A: Percent Absolute Bioavailability (%F) for TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Part B: Percentage of Total Radioactivity (TRA) in Urine (Cum Percent [%] Dose [UR]) Relative to the Administered Radioactive Dose
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Part B: Percentage of TRA in Feces (Cum%Dose[FE]) Relative to the Administered Radioactive Dose
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Part B: Percentage of TRA Recovered in in the Urine and Feces Combined (Combined Cum%Dose) Relative to the Administered Radioactive Dose
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Part A, Ceoi: Plasma Concentration at the end of Infusion for [14C]TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Part A, CL: Total Clearance for [14C]TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Part A, Vss: Volume of Distribution at Steady State After Intravenous Administration for [14C]TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Part A, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-994 and [14C]TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
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Part A, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-994 and [14C]TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Part A, t(1/2z): Terminal Disposition Half-life for TAK-994 and [14C]TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Part A, Cmax: Maximum Observed Plasma Concentration for TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Part A, Tmax: Time to Reach the Maximum Plasma Concentration for TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Part B, Cmax: Maximum Observed Plasma Concentration for TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Part B, Tmax: Time to Reach the Maximum Plasma Concentration for TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Part B, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Part B, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Part B, t(1/2z): Terminal Disposition Half-life for TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Part B, Cmax: Maximum Observed Plasma and Whole Blood TRA Concentration for TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Part B, Tmax: Time to Reach the Maximum Plasma and Whole Blood TRA Concentration (Cmax) for TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Part B, AUClast: Area Under the Plasma and Whole Blood TRA Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Part B, AUC∞: Area Under the Plasma and Whole Blood TRA Concentration-time Curve From Time 0 to Infinity for TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Part B, AUCt: Area Under the Plasma and Whole Blood TRA Concentration-time Curve From Time 0 to Time t for TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Part B, t(1/2z): Terminal Disposition Phase Half-life of Plasma and Whole Blood TRA Concentration for TAK-994
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose