| Primary | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) for TAK-954 | | The safety set included all participants who received at least one dose of the study drug (active or placebo). | Posted | | Count of Participants | | Participants | | Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52) | | | | ID | Title | Description |
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| OG000 | Treatment Dose: TAK-954 0.5 mg | TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3. | | OG001 | Treatment Dose: TAK-954 1 mg | TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3. | | OG002 | Treatment Dose: TAK-954 2 mg | TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2. |
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| Primary | Number of Participants With Clinically Significant Change From Baseline in Vital Signs for TAK-954 | | The safety set included all participants who received at least one dose of the study drug (active or placebo). | Posted | | Count of Participants | | Participants | | Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52) | | | | ID | Title | Description |
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| OG000 | Treatment Dose: TAK-954 0.5 mg | TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3. | | OG001 | Treatment Dose: TAK-954 1 mg | TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3. | | OG002 | Treatment Dose: TAK-954 2 mg | TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2. |
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| Primary | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) for TAK-954 | | The safety set included all participants who received at least one dose of the study drug (active or placebo). | Posted | | Count of Participants | | Participants | | Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52) | | | | ID | Title | Description |
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| OG000 | Treatment Dose: TAK-954 0.5 mg | TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3. | | OG001 | Treatment Dose: TAK-954 1 mg | TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3. | | OG002 | Treatment Dose: TAK-954 2 mg | TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2. |
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| Primary | Number of Participants With Clinically Notable Shifts From Baseline to Abnormal Post-dose in Clinical Laboratory Values for TAK-954 | | The safety set included all participants who received at least one dose of the study drug (active or placebo). | Posted | | Count of Participants | | Participants | | Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52) | | | | ID | Title | Description |
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| OG000 | Treatment Dose: TAK-954 0.5 mg | TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3. | | OG001 | Treatment Dose: TAK-954 1 mg | TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3. | | OG002 | Treatment Dose: TAK-954 2 mg | TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2. |
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| Primary | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 | | The pharmacokinetic (PK) set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations). | Posted | | Geometric Mean | Geometric Coefficient of Variation | picogram*hour per milliliter (pg*hr/mL) | | Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Treatment Dose: TAK-954 0.5 mg | TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3. | | OG001 | Treatment Dose: TAK-954 1 mg | TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3. | | OG002 | Treatment Dose: TAK-954 2 mg | TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2. |
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| Primary | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 | | The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations). | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg*hr/mL | | Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Treatment Dose: TAK-954 0.5 mg | TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3. | | OG001 | Treatment Dose: TAK-954 1 mg | TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3. | | OG002 | Treatment Dose: TAK-954 2 mg | TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2. |
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| Primary | Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-954 | | The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations). | Posted | | Geometric Mean | Geometric Coefficient of Variation | picogram per milliliter (pg/mL) | | Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Treatment Dose: TAK-954 0.5 mg | TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3. | | OG001 | Treatment Dose: TAK-954 1 mg | TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3. | | OG002 | Treatment Dose: TAK-954 2 mg | TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2. |
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| Primary | CL: Total Clearance After Intravenous Administration for TAK-954 | | The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations). | Posted | | Geometric Mean | Geometric Coefficient of Variation | liter per hour (L/hr) | | Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Treatment Dose: TAK-954 0.5 mg | TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3. | | OG001 | Treatment Dose: TAK-954 1 mg | TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3. | | OG002 | Treatment Dose: TAK-954 2 mg | TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2. |
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| Primary | Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-954 | | The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations). | Posted | | Geometric Mean | Geometric Coefficient of Variation | liter | | Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Treatment Dose: TAK-954 0.5 mg | TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3. | | OG001 | Treatment Dose: TAK-954 1 mg | TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3. | | OG002 | Treatment Dose: TAK-954 2 mg | TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2. |
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| Primary | Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 12 Hours Post-dose | | The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations). | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram | | Day 2 pre-dose and at multiple time points (up to 12 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Treatment Dose: TAK-954 0.5 mg | TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3. | | OG001 | Treatment Dose: TAK-954 1 mg | TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3. | | OG002 | Treatment Dose: TAK-954 2 mg | TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2. |
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| Primary | Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 24 Hours Post-dose | | The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations). PK-evaluable population where data at specified time points was available. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram | | Day 2 pre-dose and at multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Treatment Dose: TAK-954 0.5 mg | TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3. | | OG001 | Treatment Dose: TAK-954 1 mg | TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3. | | OG002 | Treatment Dose: TAK-954 2 mg | TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2. |
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| Primary | Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 36 Hours Post-dose | | The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations). | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram | | Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Treatment Dose: TAK-954 0.5 mg | TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3. | | OG001 | Treatment Dose: TAK-954 1 mg | TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3. | | OG002 | Treatment Dose: TAK-954 2 mg | TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2. |
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| Primary | Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 12 Hours Post-dose | | The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations). PK-evaluable population where data at specified time points was available. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage | | Day 2 pre-dose and at multiple time points (up to 12 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Treatment Dose: TAK-954 0.5 mg | TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3. | | OG001 | Treatment Dose: TAK-954 1 mg | TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3. | | OG002 | Treatment Dose: TAK-954 2 mg | TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2. |
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| Primary | Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 24 Hours Post-dose | | The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations). | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage | | Day 2 pre-dose and at multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Treatment Dose: TAK-954 0.5 mg | TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3. | | OG001 | Treatment Dose: TAK-954 1 mg | TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3. | | OG002 | Treatment Dose: TAK-954 2 mg | TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2. |
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| Primary | Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 36 Hours Post-dose | | The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations). | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage | | Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Treatment Dose: TAK-954 0.5 mg | TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3. | | OG001 | Treatment Dose: TAK-954 1 mg | TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3. | | OG002 | Treatment Dose: TAK-954 2 mg | TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2. |
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| Primary | CLR: Renal Clearance for TAK-954 | | The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations). | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/hr | | Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Treatment Dose: TAK-954 0.5 mg | TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3. | | OG001 | Treatment Dose: TAK-954 1 mg | TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3. | | OG002 | Treatment Dose: TAK-954 2 mg | TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2. |
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| Secondary | Number of Participants With First Stool of TAK-954 Within 36 Hours Post-dose on Day 2 | | The pharmacodynamic (PD) set included all participants who received at least one dose of the study drug (active or placebo) and had completed at least 1 PD sampling period and/or had at least 1 evaluable parameter. | Posted | | Count of Participants | | Participants | | Day 2 dosing and at multiple time points (up to 36 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Treatment Dose: TAK-954 0.5 mg | TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3. | | OG001 | Treatment Dose: TAK-954 1 mg | TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3. | | OG002 | Treatment Dose: TAK-954 2 mg | TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2. |
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| Secondary | Mean Number of Stools of TAK-954 Within 36 Hours Post-dose on Day 2 | | The PD set included all participants who received at least one dose of the study drug (active or placebo) and had completed at least 1 PD sampling period and/or had at least 1 evaluable parameter. | Posted | | Mean | Standard Deviation | stools | | Day 2 dosing and at multiple time points (up to 36 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Treatment Dose: TAK-954 0.5 mg | TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3. | | OG001 | Treatment Dose: TAK-954 1 mg | TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3. | | OG002 | Treatment Dose: TAK-954 2 mg | TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2. |
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| Secondary | Instances of Stool Type of TAK-954 Based on Bristol Stool Form Scale | Number of occurrences for each stool type was reported based on their type assessed from Bristol Stool form scale. The Bristol Stool Form Scale was used to assess the stool shape using a 7-point scale. Where, Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipation and a score of 6 or 7 indicates diarrhea. | The PD set included all participants who received at least one dose of the study drug (active or placebo) and had completed at least 1 PD sampling period and/or had at least 1 evaluable parameter. | Posted | | Number | | number of occurrences | | Day 2 dosing and at multiple time points (up to 36 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Treatment Dose: TAK-954 0.5 mg | TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3. | | OG001 | Treatment Dose: TAK-954 1 mg | TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3. | | OG002 |
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