| Primary | Period 1: Percent Absolute Bioavailability (%F) for TAK-935 | Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma TAK-935 as [Actual Dose (IV) x Area Under the Concentration-time Curve from Time 0 to Infinity {AUCinf} (oral)] / [Actual Dose (oral) x AUCinf (IV)] x 100. | Pharmacokinetic (PK) Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-935 3×100 mg tablets and 50 μg IV dose in Treatment Period 1 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percent absolute bioavailability | | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1 | | | | ID | Title | Description |
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| OG000 | TAK-935 300 mg + [14C]TAK-935 50 μg | TAK-935 3×100 mg tablets, orally, followed by [14C]TAK-935 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1. |
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| Primary | Period 2: Total Radioactivity Expressed as Cumulative Percentage of Dose of [14C]TAK-935 Excreted in Urine and Feces Combined [Combined Cum%Dose] | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage of dose | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine (CumAe[u]) | | Analysis Population Description: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mg equivalents (eq) of parent drug | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Feces (CumAe[f]) | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mg eq of parent drug | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine and Feces Combined (Combined CumAe) | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mg eq of parent drug | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Urine (Cum%Dose[u]) | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage of dose | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Feces (Cum%Dose[f]) | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage of dose | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: Cmax: Maximum Observed Plasma Concentration of TAK-935 | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-935 | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Median | Full Range | hours (hr) | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: t(1/2)z: Terminal Disposition Phase Half-life of TAK-935 in Plasma | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. Overall number analyzed is the number of participants with data available for analysis. | Posted | | Median | Full Range | hr | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935 | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. Overall number analyzed is the number of participants with data available for analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-935 | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-935 | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: Cmax: Maximum Observed Plasma Radioactivity Concentration | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng eq/mL | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: Tmax: Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax) | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Median | Inter-Quartile Range | hr | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Radioactivity Concentration | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Median | Full Range | hr | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: AUC0-inf: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng eq*hr/mL | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: AUC0-t: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Time t | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng eq*hr/mL | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: AUC0-last: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng eq*hr/mL | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: Cmax: Maximum Observed Whole Blood Radioactivity Concentration | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng eq/g | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: Tmax: Time to Reach the Maximum Whole Blood Radioactivity Concentration (Cmax) | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Median | Full Range | hr | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Whole Blood Radioactivity Concentration | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Median | Full Range | hr | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: AUC0-inf: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanograms (ng) eq*hr/g | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: AUC0-t: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to t | | The data for TAK-935 concentration in whole blood were not collected therefore AUC0-t cannot be determined and not available. | Posted | | | | | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: AUC0-last: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng eq*hr/g | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: CLR: Renal Clearance for TAK-935 in Urine | Renal clearance (CLr) is the volume of plasma entering the kidney that is completely cleared of drug per unit of time. | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/hr | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: Aet1-t2: Amount of TAK-935 Excreted in the Urine in Each Collection Interval | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2, with data available for analysis at the given timepoint were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mg eq | | 0-12, 12-24, 24-48, 48-72, 72-96, 96-120 hours post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Primary | Period 2: Whole Blood to Plasma Partitioning Ratio: Change From Baseline in Percentage of [14C]TAK-935 Radioactivity in Whole Blood Relative to Plasma | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. Number analyzed are the number of participants with data available for analysis at the given timepoint. | Posted | | Mean | Standard Deviation | ratio | | 0.17, 0.42, 0.75, 1.5, 2.5, 4.5, 8, 12, and 24 hours post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Secondary | Period 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]TAK-935 | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received [14C]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | picograms (pg) eq /mL | | Day 1: At the end of infusion (at 15 minutes post dose) in Treatment Period 1 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 50 μg | [14C]TAK-935 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-935 oral dose, followed by a Washout Period of at least 7 days. |
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| Secondary | Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-935 After Oral Administration | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-935 3×100 mg tablets in Treatment Period 1 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1 | | | | ID | Title | Description |
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| OG000 | TAK-935 300 mg | TAK-935 3×100 mg tablets, orally, once on Day 1 of Treatment Period 1. |
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| Secondary | Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-935 After Oral Administration | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-935 3×100 mg tablets in Treatment Period 1 were evaluated for this outcome measure. | Posted | | Median | Full Range | hr | | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1 | | | | ID | Title | Description |
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| OG000 | TAK-935 300 mg | TAK-935 3×100 mg tablets, orally, once on Day 1 of Treatment Period 1. |
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| Secondary | Period 1: AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935 After Oral Administration | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-935 3×100 mg tablets in Treatment Period 1 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1 | | | | ID | Title | Description |
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| OG000 | TAK-935 300 mg | TAK-935 3×100 mg tablets, orally, once on Day 1 of Treatment Period 1. |
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| Secondary | Period 1: AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]TAK-935 After IV Administration | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received [14C]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg eq*hr/mL | | Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose in Treatment Period 1 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 50 μg | [14C]TAK-935 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-935 oral dose, followed by a Washout Period of at least 7 days. |
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| Secondary | Period 1: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to t After Oral Administration | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-935 3×100 mg tablets in Treatment Period 1 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1 | | | | ID | Title | Description |
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| OG000 | TAK-935 300 mg | TAK-935 3×100 mg tablets, orally, once on Day 1 of Treatment Period 1. |
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| Secondary | Period 1: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-935 After IV Administration | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received [14C]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg eq*hr/mL | | Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose in Treatment Period 1 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 50 μg | [14C]TAK-935 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-935 oral dose, followed by a Washout Period of at least 7 days. |
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| Secondary | Period 1: AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-935 After Oral Administration | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-935 3×100 mg tablets in Treatment Period 1 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1 | | | | ID | Title | Description |
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| OG000 | TAK-935 300 mg | TAK-935 3×100 mg tablets, orally, once on Day 1 of Treatment Period 1. |
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| Secondary | Period 1: AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]TAK-935 After IV Administration | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received [14C]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg eq*hr/mL | | Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose in Treatment Period 1 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 50 μg | [14C]TAK-935 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-935 oral dose, followed by a Washout Period of at least 7 days. |
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| Secondary | Period 1: t(1/2)z: Terminal Disposition Half-life for TAK-935 After Oral Administration in Plasma | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-935 3×100 mg tablets in Treatment Period 1 were evaluated for this outcome measure. | Posted | | Median | Full Range | hr | | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose | | | | ID | Title | Description |
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| OG000 | TAK-935 300 mg | TAK-935 3×100 mg tablets, orally, once on Day 1 of Treatment Period 1. |
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| Secondary | Period 1: t(1/2)z: Terminal Disposition Half-life for [14C]TAK-935 After IV Administration in Plasma | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received [14C]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure. | Posted | | Median | Full Range | hr | | Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 50 μg | [14C]TAK-935 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-935 oral dose, followed by a Washout Period of at least 7 days. |
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| Secondary | Period 1: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine (CumAe[u]) After IV Administration | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received [14C]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure. Overall number analyzed is the number of participants with data available for analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | µg eq | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 50 μg | [14C]TAK-935 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-935 oral dose, followed by a Washout Period of at least 7 days. |
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| Secondary | Period 1: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Feces (CumAe[f]) After IV Administration | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received [14C]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | µg eq | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 50 μg | [14C]TAK-935 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-935 oral dose, followed by a Washout Period of at least 7 days. |
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| Secondary | Period 1: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine and Feces Combined (Combined CumAe) After IV Administration | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received [14C]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure. Overall number analyzed is the number of participants with data available for analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | µg eq | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 50 μg | [14C]TAK-935 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-935 oral dose, followed by a Washout Period of at least 7 days. |
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| Secondary | Period 1: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Urine (Cum%Dose[u]) After IV Administration | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received [14C]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage of dose | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 50 μg | [14C]TAK-935 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-935 oral dose, followed by a Washout Period of at least 7 days. |
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| Secondary | Period 1: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Feces (%Dose[f]) After IV Administration | | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received [14C]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage of dose | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 50 μg | [14C]TAK-935 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-935 oral dose, followed by a Washout Period of at least 7 days. |
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| Secondary | Period 2: Metabolic Profile of TAK-935 in Plasma After Oral Administration of [14C]TAK-935 | The metabolic profile of TAK-935 after oral administration of [14C]TAK-935 was done to assess the presence of TAK-935 and various metabolites (M1 to M9) in plasma in at least one sample using radiometric detection and/or liquid chromatography mass spectroscopy (LCMS). The presence of any metabolite is indicated as '1' and absence is indicated as '0'. Only categories with value '1' are reported. | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Number | | sample positive | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg (Plasma) | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Secondary | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | The metabolic profile of TAK-935 after oral administration of [14C]TAK-935 was done to assess the presence of TAK-935 and various metabolites (M1 to M9) in urine and feces in at least one sample using radiometric detection and/or LCMS. The presence of any metabolite is indicated as '1' and absence is indicated as '0'. Data is reported separately for urine and feces. | PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of [14C]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. | Posted | | Number | | sample positive | | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | | | | ID | Title | Description |
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| OG000 | [14C]TAK-935 300 mg (Urine) | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. | | OG001 | [14C]TAK-935 300 mg (Feces) | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Secondary | Percentage of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) | 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 (example, 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 TEAE is defined as an AE that is starting or worsening at the time of or after study drug administration. | Safety Population included all participants who received at least one dose of the study drug. As prespecified in the protocol data for adverse events was collected and reported for Period 1 and Period 2. | Posted | | Number | | percentage of participants | | From first dose up to 30 days after last dose of study drug (up to approximately 40 days) | | | | ID | Title | Description |
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| OG000 | TAK-935 300 mg + [14C]TAK-935 50 μg | TAK-935 3×100 mg tablets, orally, followed by [14C]TAK-935 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1. | | OG001 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Secondary | Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | | Safety Population included all participants who received at least one dose of the study drug. As prespecified in the protocol data for this outcome measure was collected and reported for Period 1 and Period 2. | Posted | | Number | | percentage of participants | | From first dose up to 30 days after last dose of study drug (up to approximately 40 days) | | | | ID | Title | Description |
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| OG000 | TAK-935 300 mg + [14C]TAK-935 50 μg | TAK-935 3×100 mg tablets, orally, followed by [14C]TAK-935 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1. | | OG001 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Secondary | Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Vital Sign Parameters | Vital Signs included blood pressure (systolic and diastolic), heart rate (HR), respiratory rate, and temperature. | Safety Population included all participants who received at least one dose of the study drug. As prespecified in the protocol data for this outcome measure was collected and reported for Period 1 and Period 2. | Posted | | Number | | percentage of participants | | From first dose up to 30 days after last dose of study drug (up to approximately 40 days) | | | | ID | Title | Description |
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| OG000 | TAK-935 300 mg + [14C]TAK-935 50 μg | TAK-935 3×100 mg tablets, orally, followed by [14C]TAK-935 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1. | | OG001 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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| Secondary | Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Laboratory Parameters | The laboratory parameters included tests for serum chemistry, hematology, coagulation, and urinalysis. | Safety Population included all participants who received at least one dose of the study drug. As prespecified in the protocol data for this outcome measure was collected and reported for Period 1 and Period 2. | Posted | | Number | | percentage of participants | | From first dose up to 30 days after last dose of study drug (up to approximately 40 days) | | | | ID | Title | Description |
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| OG000 | TAK-935 300 mg + [14C]TAK-935 50 μg | TAK-935 3×100 mg tablets, orally, followed by [14C]TAK-935 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1. | | OG001 | [14C]TAK-935 300 mg | [14C]TAK-935 300 mg (approximately 100 μCi), solution, orally, under fasted state, once on Day 1 of Treatment Period 2. |
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