| Primary | Cumulative Percentage of Administered Radioactivity Recovered in Urine | | The pharmacokinetic (PK) analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available. | Posted | | Mean | Standard Deviation | percentage of radioactive dose | | Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| | | Title | Denominators | Categories |
|---|
| 0 to 264 hours | | | | 0 to 312 hours | |
| |
| Primary | Cumulative Percentage of Administered Radioactivity Recovered in Feces | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available. | Posted | | Mean | Standard Deviation | percentage of radioactive dose | | Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | Cumulative Percentage of Radioactivity in Urine and Feces Combined | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available. | Posted | | Mean | Standard Deviation | percentage of radioactive dose | | Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine and Feces Combined | Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery. | PK analysis set: All participants of safety set with sufficient data to facilitate at least 1 PK parameter from concentration time data. Single value is available for Metabolite (M) 16, M4, and M5 because they co-eluted under chromatographic conditions. Single sampling method used across participants, therefore there was no measure of dispersion. | Posted | | Number | | percentage of dose | | Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine | Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery. | PK analysis set: All participants of safety set with sufficient data to facilitate at least 1 PK parameter from concentration time data. Single value is available for Metabolite (M) 16, M4, and M5 because they co-eluted under chromatographic conditions. Single sampling method used across participants, therefore there was no measure of dispersion. | Posted | | Number | | Percentage of dose | | Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Feces | Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery. | PK analysis set: All participants of safety set with sufficient data to facilitate at least 1 PK parameter from concentration time data. Single value is available for Metabolite (M) 16, M4, and M5 because they co-eluted under chromatographic conditions. Single sampling method used across participants, therefore there was no measure of dispersion. | Posted | | Number | | percentage of dose | | Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | Mean Percent of Total Radioactivity in Plasma for TAK-954 and TAK-954 Metabolites | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. Data is reported for TAK-954. Data for metabolites are not reported because none exceeded greater than (>) 6% of the total plasma radioactivity. | Posted | | Mean | Standard Deviation | percentage of total radioactivity | | Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | Cumulative Percentage of Dose Excreted in Urine for TAK-954 | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available. | Posted | | Mean | Standard Deviation | percentage of dose | | Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | Cumulative Percentage of Dose Excreted in Feces for TAK-954 | The cumulative percentage of dose excreted in feces as TAK-954 derived from 0-168 hour sampling was normalized for 100% recovery. | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. Single sampling method used across participants, therefore there was no measure of dispersion. | Posted | | Number | | percentage of dose | | Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954 | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available. | Posted | | Mean | Standard Deviation | nanogram equivalent/milliliter(ng eq/mL) | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | Cmax: Maximum Observed Plasma and Whole Blood Concentrations of Radioactivity for [14C]-TAK-954 | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. | Posted | | Geometric Mean | Full Range | ng eq/mL | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | Cmax: Maximum Observed Plasma Concentration for TAK-954 and TAK-954 Metabolites | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. PK data for TAK-954 metabolite THRX913682 could not be evaluated since its plasma levels were less than (<) lower limit of quantification. | Posted | | Geometric Mean | Full Range | nanogram per milliliter (ng/mL) | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | 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-954 | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. | Posted | | Geometric Mean | Full Range | h*ng eq/mL | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 and TAK-954 Metabolites | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. PK data for TAK-954 metabolite THRX913682 could not be evaluated since its plasma levels were < lower limit of quantification. | Posted | | Geometric Mean | Full Range | hour*nanogram per milliliter (h*ng/mL) | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | AUC∞: Area Under the Plasma and Whole Blood Radioactivity-time Curve From Time 0 to Infinity for [14C]-TAK-954 | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. | Posted | | Geometric Mean | Full Range | h*ng eq/mL | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 and TAK-954 Metabolites | | The PK analysis set. PK data for metabolites could not be evaluated since metabolites were < lower limit of quantification and apparent terminal elimination portion of the concentration-time curve could not be characterized. | Posted | | Geometric Mean | Full Range | h*ng/mL | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | Tmax: Time to Reach the Maximum Plasma and Whole Blood Radioactivity for [14C]-TAK-954 | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. | Posted | | Median | Full Range | hour | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-954 and TAK-954 Metabolites | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. PK data for TAK-954 metabolite (THRX913682) could not be evaluated since metabolites were < lower limit of quantification. | Posted | | Geometric Mean | Full Range | hour | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | t1/2z: Terminal Disposition Phase Half-life of Radioactivity in Plasma and Whole Blood for [14C]-TAK-954 | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. | Posted | | Geometric Mean | Full Range | hour | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | t1/2z: Terminal Disposition Phase Half-life in Plasma for TAK-954 and TAK-954 Metabolites | | The PK analysis set. PK data for metabolites could not be evaluated since metabolites were < lower limit of quantification and apparent terminal elimination portion of the concentration-time curve could not be characterized. | Posted | | Geometric Mean | Full Range | hour | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | CL: Total Clearance After Intravenous Administration for [14C]-TAK-954 | | No participant was analyzed since this outcome measure was not planned to be assessed but added in the protocol summary by error. | Posted | | | | | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| | | |
| Primary | CL: Total Clearance of TAK-954 After Intravenous Administration of [14C]-TAK-954 | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. | Posted | | Geometric Mean | Full Range | L/h | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for [14C]-TAK-954 | | No participant was analyzed since this outcome measure was not planned to be assessed but added in the protocol summary by error. | Posted | | | | | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| | |
| Primary | Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-954 | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. | Posted | | Geometric Mean | Full Range | liter | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | Aet Urine: Amount of Total Radioactivity Excreted in Urine From Time 0 to Time t for [14C]-TAK-954 | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. | Posted | | Mean | Standard Deviation | microgram equivalent (mcg eq) | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | Aet Urine: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-954 | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. | Posted | | Mean | Standard Deviation | microgram (mcg) | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | Aet Feces: Amount of Total Radioactivity Excreted in Feces From Time 0 to Time t for [14C]-TAK-954 | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. | Posted | | Mean | Standard Deviation | mcg eq | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | Fet Urine: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-954 | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. | Posted | | Mean | Standard Deviation | percentage of dose | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | Fet Urine: Fraction of Total Radioactivity Excreted in Urine From Time 0 to Time t for [14C]-TAK-954 | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. | Posted | | Mean | Standard Deviation | percentage of dose | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Primary | Fet Feces: Fraction of Radioactivity Excreted in Feces From Time 0 to Time t for [14C]-TAK-954 | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. | Posted | | Mean | Standard Deviation | percentage of dose | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Secondary | Ratio of Total Radioactivity in Whole Blood to Plasma | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available. | Posted | | Mean | Standard Deviation | ratio | | Day 1 pre-dose and at multiple time points (up to 264 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Secondary | Ratio of AUC∞: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 to Total Radioactivity in Plasma TAK-954 | | The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. | Posted | | Mean | Standard Deviation | ratio | | Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| |
| Secondary | Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) | | The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug. | Posted | | Number | | percentage of participants | | Baseline up to Day 31 | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| | |
| Secondary | Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation of [14C]-TAK-954 | | The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug. | Posted | | Number | | percentage of participants | | Baseline up to Day 15 | | | | ID | Title | Description |
|---|
| OG000 | [14C]-TAK-954 0.5 mg | [14C]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1. |
| | |