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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1166-3774 | Registry Identifier | WHO | |
| JapicCTI-152790 | Registry Identifier | JapicCTI |
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The purpose of this study is to examine the effects of renal and hepatic impairment on TAK-272 pharmacokinetics with a single oral administration of TAK-272 in participants with renal or hepatic impairment.
This study is a phase I, open-label, parallel-group, comparative study to evaluate the effects of renal or hepatic impairment on pharmacokinetics of TAK-272 with a single oral administration of TAK-272 in participants with renal or hepatic impairment as compared with participants with normal renal and hepatic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with normal renal function: TAK-272 40 mg | Active Comparator | Fasted single oral administration of TAK-272 40 milligram (mg) |
|
| Participants with mild renal impairment: TAK-272 40 mg | Experimental | Fasted single oral administration of TAK-272 40 mg |
|
| Participants with moderate renal impairment: TAK-272 40 mg | Experimental | Fasted single oral administration of TAK-272 40 mg |
|
| Participants with severe renal impairment: TAK-272 40 mg | Experimental | Fasted single oral administration of TAK-272 40 mg |
|
| Hemodialysis participants: TAK-272 40 mg | Experimental | Fasted single oral administration of TAK-272 40 mg |
|
| Participants with normal hepatic function: TAK-272 40 mg | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-272 | Drug | TAK-272 tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Free Form of TAK-272 (TAK-272F) and Its Metabolite M-I | Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose | |
| Cmax: Maximum Observed Plasma Concentration for TAK-272F and Its Metabolite M-I | Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose | |
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-272F and Its Metabolite M-I | Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose | |
| AUClast,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration for TAK-272F | AUClast,u is the area under the concentration-time curve of the unbound drug in plasma over the time interval from 0 to time of last quantifiable post-dose of TAK-272. | Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose |
| Cmax,u: Maximum Unbound Plasma Concentration for TAK-272F | Cmax,u is the peak unbound plasma concentration of a drug after administration, obtained directly from the unbound plasma concentration-time curve. | Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose |
| AUC∞,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for TAK-272F |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | Baseline up to Day 8 of each Cohort | |
| Number of Participants With TEAE Related to Vital Signs | Number of participants with TEAE related to vital signs was reported in this outcome measure. The related event to report was only "Blood Pressure Decreased" throughout this study. |
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Inclusion Criteria:
All participants
In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements.
Signs and dates a written, informed consent form prior to the initiation of any study procedures.
Is either male or female and aged 20 to 85 years, inclusive, at the time of informed consent.
Weighs at least 45 kilogram (kg) for males and 40 kg for females and have a body mass index (BMI) of less than (<) 35.0 kilogram per square meter (kg/m^2) at screening and Day 1.
A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent until 12 weeks after study drug administration.
A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of informed consent until 1 month after the completion of the study.
Participants with normal renal or hepatic function (Cohorts 1R and 1H)
Estimated glomerular filtration rate (eGFR) is greater than or equal to (>=) 90 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) at screening.
Based on the participant's medical history, clinical laboratory values, and physical examination findings, the investigator or subinvestigator judges the participant to be in good health (hypertension, type 2 diabetes, and hypercholesteremia or dyslipidemia are controlled, if present).
Is within +/-10 years of the mean age and +/-20 percent (%) of the mean weight for the 24 participants with renal impairment and 12 participants with hepatic impairment administered the study drug.
Participants with renal impairment (Cohorts 2R, 3R, 4R, 5R)
Falls into any of the following categories:
For non-hemodialysis participants, difference in eGFR obtained between 3 months and 7 days before screening from eGFR at screening is less than or equal to (<=) 30%.
Participants with hepatic impairment (Cohorts 2H, 3H)
In observations during the screening period, those diagnosed with hepatic impairment corresponding to any of the following Child-Pugh classes:
Is diagnosed by the investigator or subinvestigator with hepatic impairment that has remained stable during the 3 months before screening.
Exclusion Criteria:
All participants
Has received any investigational product within 16 weeks (112 days) prior to the start of study drug administration.
Has received TAK-272 in a previous clinical study.
Is an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
Has a history of cancer. This does not include individuals who have been in remission for at least 1 year prior to the start of screening and who are judged by the investigator or subinvestigator to have had no recurrence during the study.
Has a known hypersensitivity or allergy to any component of the TAK-272 formulation or renin inhibitors.
Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
Has any positive urine drug test result at screening (including test for alcohol) if a non-hemodialysis participant.
Has taken any excluded medication or food product listed in the Excluded Medications and Dietary Products section during the period in which excluded medication use is prohibited, or needs to take any excluded medication or food product during the study.
Previously has undergone kidney or liver transplantation.
Has poor peripheral venous access.
Has undergone whole blood collection of 800 milliliter (mL) or more within 52 weeks (364 days) prior to the start of study drug administration.
Has undergone whole blood collection of 200 mL or more within 4 weeks (28 days) or 400 mL or more within 12 weeks (84 days) for males and 16 weeks (112 days) for females prior to the start of study drug administration.
Has undergone blood component collection within 2 weeks (14 days) prior to the start of study drug administration.
Has onset of myocardial infarction or coronary revascularization within 6 months before screening.
Has a history of abdominal surgery (excluding laparoscopic cholecystectomy or appendectomy without complications) or chest or non-peripheral vascular surgery within 6 months before screening.
Has onset of acute disease (example, renal and urinary tract disease) within 30 days before screening.
Has clinically significant abnormal electrocardiogram (ECG) in the screening period or the pretreatment examination.
Has clinically significant hyperkalemia.
If female, the participant is pregnant or lactating or intending to become pregnant before, during or within 1 month after participating in this study, or intending to donate ova during such time period.
If male, the participant intends to donate sperm during the course of this study or for 12 weeks thereafter.
In the opinion of the investigator or subinvestigator, is unlikely to comply with protocol or is unsuitable for any other reason.
Participants with normal renal and hepatic function (Cohorts 1R and 1H)
Has uncontrolled, clinically significant hepatic, renal, neurologic, cardiovascular, blood, pulmonary, metabolic, gastrointestinal, urologic or endocrine disease, immune disease, infection or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
Has clinical laboratory results at screening suggestive of a clinically significant underlying disease other than controlled hypertension, type 2 diabetes, hypercholesteremia, or dyslipidemia.
Systolic blood pressure is <80 millimeter of mercury (mmHg) at screening, in the pretreatment examination, or in the examination prior to the start of study drug administration and has repeated instances of the findings listed below, suggesting the presence of hypotension:
- Dizziness postural, facial pallor, cold sweats.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is >2.0 times higher than the upper limit of normal at screening.
Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen/antibody, or serological reactions for syphilis at screening.
Participants with renal impairment (Cohorts 2R, 3R, 4R, 5R)
Has uncontrolled, clinically significant hepatic, neurologic, cardiovascular, blood, pulmonary, metabolic, gastrointestinal, urologic or endocrine disease, immune disease, infection or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
Sitting systolic blood pressure is <110 mmHg at screening, in the pretreatment examination, or in the examination before administration on Day 1.
ALT or AST is >2.0 times higher than the upper limit of normal at screening.
Has a positive test result for HBsAg, HCV antibody, HIV antigen/antibody, or serological reactions for syphilis at screening.
Participants with hepatic impairment (Cohorts 2H, 3H)
Has uncontrolled, clinically significant renal, neurologic, cardiovascular, blood, pulmonary, metabolic, gastrointestinal, urologic or endocrine disease, immune disease, infection or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
Has ascites requiring invasive treatment.
Systolic blood pressure is <80 mmHg at screening, in the pretreatment examination, or in the examination prior to the start of study drug administration and has repeated instances of the findings listed below, suggesting the presence of hypotension:
- Dizziness postural, facial pallor, cold sweats.
eGFR is <60 mL/min/1.73 m^2 at screening.
Has a positive test result for HIV antigen/antibody or the participant has a positive test result for serological reactions for syphilis and syphilis is judged not to have been cured at screening.
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| Name | Affiliation | Role |
|---|---|---|
| General Manager | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kurume | Fukuoka | Japan | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30194585 | Derived | Shimasaki Y, Sakaki M, Itou M, Kobayashi T, Aso M, Kagawa T, Saiki T, Matsuno K, Sano Y, Shimizu K, Kuroda S, Koumura E. Pharmacokinetics and Safety After a Single Dose of Imarikiren in Subjects with Renal or Hepatic Impairment. Clin Drug Investig. 2018 Nov;38(11):1041-1051. doi: 10.1007/s40261-018-0695-4. |
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Participants with normal renal (1R) and hepatic (1H) function; those who had historical diagnosis of renal (mild [2R], moderate [3R], severe or end-stage renal failure with no hemodialysis [4R], end-stage renal failure [with hemodialysis] [5R]); hepatic impairment (mild [2H] and moderate [3H]) were enrolled to receive TAK-272 40 milligram (mg).
Participants took part in the study at 4 investigative sites in Japan from 1 March 2015 to 10 June 2016.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1R: Normal Renal Function | Participants with normal renal function (estimated glomerular filtration rate [eGFR] greater than or equal to [>=] 90 milliliter per minute per 1.73 square meter [mL/min/1.73 m^2]) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. |
| FG001 | Cohort 2R: Mild Renal Impairment | Participants with mild renal impairment (eGFR >=60, less than [<] 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. |
| FG002 | Cohort 3R: Moderate Renal Impairment | Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. |
| FG003 | Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis) | Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. |
| FG004 | Cohort 5R: End-stage Renal Failure (Hemodialysis) | Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (dialysis on Day 1 after dosing). After Part 1 follow-up period, then the same participants received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-dialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day of follow up in Part 1. |
| FG005 | Cohort 1H: Normal Hepatic Function | Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. |
| FG006 | Cohort 2H: Mild Hepatic Impairment | Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time [PT] or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity. |
| FG007 | Cohort 3H: Moderate Hepatic Impairment | Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The plasma pharmacokinetic (PK) set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1R: Normal Renal Function | Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. |
| BG001 | Cohort 2R: Mild Renal Impairment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Free Form of TAK-272 (TAK-272F) and Its Metabolite M-I | The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK. | Posted | Geometric Mean | Standard Deviation | nanogram*hour per milliliter (ng*hr/mL) | Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose |
|
Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 8 of each Cohort
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1R: Normal Renal Function | Participants with normal renal function (eGFR>=90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
Not provided
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
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| ID | Term |
|---|---|
| C000628410 | imarikiren hydrochloride |
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Fasted single oral administration of TAK-272 40 mg |
|
| Participants with mild hepatic impairment: TAK-272 40 mg | Experimental | Fasted single oral administration of TAK-272 40 mg |
|
| Participants with moderate hepatic impairment: TAK-272 40 mg | Experimental | Fasted single oral administration of TAK-272 40 mg |
|
AUC∞,u is the area under the concentration-time curve of the unbound drug in plasma over the time interval from 0 to infinity of TAK-272. |
| Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-272F and Its Metabolite M-I | Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose |
| Apparent Clearance (CL/F) for TAK-272F | Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose |
| CLu/F: Apparent Clearance for Unbound Drug After Extravascular Administration for TAK-272F | CLu/F is the apparent clearance for unbound drug after extravascular administration of TAK-272. | Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose |
| Cumulative Urinary Excretion Ratio of TAK-272F and Its Metabolite M-I From 0 to 72 Hours Post-dose in Cohorts 1R, 2R, 3R, 4R, 1H, 2H and 3H | Urinary excretion ratio (percentage [%] of dose) of TAK-272 and its metabolite M-I in urine was calculated for each participant. | Day 1: Pre-dose and at multiple time points (4, 8, 12, 24, 36, 48, 72 hours post dose; up to 72 hours) post-dose |
| Plasma Protein Binding Rate of TAK-272F in Cohorts 1R, 2R, 3R, 4R, 5R, 1H, 2H and 3H | Plasma protein binding rate was the percentage of unbound fraction of TAK-272F in plasma protein. | Baseline |
| Excretion Ratio of TAK-272F in Dialysate in Cohort 5R | Excretion ratio (% of dose) of TAK-272F in dialysis fluid was calculated for each participant. | Day 1: Pre-dose, up to 6 hours post-dose |
| Baseline up to Day 8 of each Cohort |
| Number of Participants With TEAE Related to Body Weight | Number of participants with TEAE related to body weight was reported in this outcome measure. There were no events to report as TEAE related to body weight throughout this study. | Baseline up to Day 8 of each Cohort |
| Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECG) | Number of participants with TEAE related to ECG was reported in this outcome measure. There were no events to report as TEAE related to ECG throughout this study. | Baseline up to Day 8 of each Cohort |
| Number of Participants With TEAE Related to Laboratory Tests | Number of participants with TEAE related to laboratory tests was reported in this outcome measure. The related event to report was only "Alanine Aminotransferase Increased" throughout this study. | Baseline up to Day 8 of each Cohort |
| Moriya |
| Ibaragi |
| Japan |
| Sagamihara | Kanagawa | Japan |
| Shinagawa | Tokyo | Japan |
Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. |
| BG002 | Cohort 3R: Moderate Renal Impairment | Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. |
| BG003 | Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis) | Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. |
| BG004 | Cohort 5R: End-stage Renal Failure (Hemodialysis) | Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (dialysis on Day 1 after dosing). After Part 1 follow-up period, then the same participants received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-dialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day of follow up in Part 1. |
| BG005 | Cohort 1H: Normal Hepatic Function | Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. |
| BG006 | Cohort 2H: Mild Hepatic Impairment | Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity. |
| BG007 | Cohort 3H: Moderate Hepatic Impairment | Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeter (cm) |
|
| Weight | Mean | Standard Deviation | kilogram (kg) |
|
| Body Mass Index | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
|
| Smoking Classification | Count of Participants | Participants |
|
| Alcohol Classification | Count of Participants | Participants |
|
| Caffeine Classification | Participants who were answered Yes or No for a question "Take Caffeine in Daily Life?" were reported. | Count of Participants | Participants |
|
| Estimated Glomerular Filtration Rate (eGFR) | Mean | Standard Deviation | mL/min/1.73 m^2 |
|
| Alpha1 Acid Glycoprotein (AGP) | Mean | Standard Deviation | milligram per deciliter (mg/dL) |
|
| OG001 |
| Cohort 2R: Mild Renal Impairment |
Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. |
| OG002 | Cohort 3R: Moderate Renal Impairment | Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. |
| OG003 | Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis) | Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. |
| OG004 | Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis) | Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing). |
| OG005 | Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis) | Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1. |
| OG006 | Cohort 1H: Normal Hepatic Function | Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. |
| OG007 | Cohort 2H: Mild Hepatic Impairment | Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity. |
| OG008 | Cohort 3H: Moderate Hepatic Impairment | Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity. |
|
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| Primary | Cmax: Maximum Observed Plasma Concentration for TAK-272F and Its Metabolite M-I | The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK. | Posted | Geometric Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose |
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| Primary | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-272F and Its Metabolite M-I | The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose |
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| Primary | AUClast,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration for TAK-272F | AUClast,u is the area under the concentration-time curve of the unbound drug in plasma over the time interval from 0 to time of last quantifiable post-dose of TAK-272. | The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose |
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| Primary | Cmax,u: Maximum Unbound Plasma Concentration for TAK-272F | Cmax,u is the peak unbound plasma concentration of a drug after administration, obtained directly from the unbound plasma concentration-time curve. | The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK. | Posted | Geometric Mean | Standard Deviation | ng/mL | Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose |
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| Primary | AUC∞,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for TAK-272F | AUC∞,u is the area under the concentration-time curve of the unbound drug in plasma over the time interval from 0 to infinity of TAK-272. | The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose |
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| Primary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-272F and Its Metabolite M-I | The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK. | Posted | Median | Full Range | hour | Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose |
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| Primary | Apparent Clearance (CL/F) for TAK-272F | The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK. | Posted | Mean | Standard Deviation | liter per hour (L/hr) | Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose |
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| Primary | CLu/F: Apparent Clearance for Unbound Drug After Extravascular Administration for TAK-272F | CLu/F is the apparent clearance for unbound drug after extravascular administration of TAK-272. | The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK. | Posted | Mean | Standard Deviation | L/hr | Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose |
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| Primary | Cumulative Urinary Excretion Ratio of TAK-272F and Its Metabolite M-I From 0 to 72 Hours Post-dose in Cohorts 1R, 2R, 3R, 4R, 1H, 2H and 3H | Urinary excretion ratio (percentage [%] of dose) of TAK-272 and its metabolite M-I in urine was calculated for each participant. | The urine PK analysis population where urinary excretion data on Day 1 was available. The urine PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for urine PK. | Posted | Mean | Standard Deviation | percentage of dose | Day 1: Pre-dose and at multiple time points (4, 8, 12, 24, 36, 48, 72 hours post dose; up to 72 hours) post-dose |
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| Primary | Plasma Protein Binding Rate of TAK-272F in Cohorts 1R, 2R, 3R, 4R, 5R, 1H, 2H and 3H | Plasma protein binding rate was the percentage of unbound fraction of TAK-272F in plasma protein. | The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK. | Posted | Mean | Standard Deviation | % of unbound fraction of TAK-272F | Baseline |
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| Primary | Excretion Ratio of TAK-272F in Dialysate in Cohort 5R | Excretion ratio (% of dose) of TAK-272F in dialysis fluid was calculated for each participant. | The dialysate PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for dialysate PK. | Posted | Mean | Standard Deviation | percentage of dose | Day 1: Pre-dose, up to 6 hours post-dose |
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| Secondary | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | The safety analysis set included all participants who were treated with at least 1 dose of study drug. | Posted | Number | participants | Baseline up to Day 8 of each Cohort |
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| Secondary | Number of Participants With TEAE Related to Vital Signs | Number of participants with TEAE related to vital signs was reported in this outcome measure. The related event to report was only "Blood Pressure Decreased" throughout this study. | The safety analysis set included all participants who were treated with at least 1 dose of study drug. | Posted | Number | participants | Baseline up to Day 8 of each Cohort |
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| Secondary | Number of Participants With TEAE Related to Body Weight | Number of participants with TEAE related to body weight was reported in this outcome measure. There were no events to report as TEAE related to body weight throughout this study. | The safety analysis set included all participants who were treated with at least 1 dose of study drug. | Posted | Number | participants | Baseline up to Day 8 of each Cohort |
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| Secondary | Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECG) | Number of participants with TEAE related to ECG was reported in this outcome measure. There were no events to report as TEAE related to ECG throughout this study. | The safety analysis set included all participants who were treated with at least 1 dose of study drug. | Posted | Number | participants | Baseline up to Day 8 of each Cohort |
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| Secondary | Number of Participants With TEAE Related to Laboratory Tests | Number of participants with TEAE related to laboratory tests was reported in this outcome measure. The related event to report was only "Alanine Aminotransferase Increased" throughout this study. | The safety analysis set included all participants who were treated with at least 1 dose of study drug. | Posted | Number | participants | Baseline up to Day 8 of each Cohort |
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| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | Cohort 2R: Mild Renal Impairment | Participants with mild renal impairment (eGFR >=60,< 90 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. | 0 | 6 | 1 | 6 |
| EG002 | Cohort 3R: Moderate Renal Impairment | Participants with moderate renal impairment (eGFR >=30, <60 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. | 0 | 6 | 1 | 6 |
| EG003 | Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis) | Participants with severe or end-stage renal failure undergoing no hemodialysis (eGFR <30 mL/min/1.73 m^2) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. | 0 | 6 | 2 | 6 |
| EG004 | Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis) | Part 1 is hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 1 (hemodialysis on Day 1 after dosing). | 0 | 6 | 2 | 6 |
| EG005 | Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis) | Part 2 is non-hemodialysis part in the Cohort 5R. Participants with hemodialysis received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period in Part 2 (non-hemodialysis on Day 1). Participants who completed Cohort 5R-Part 1 started Part 2 after completion of 2-day follow up period in Part 1. | 0 | 6 | 1 | 6 |
| EG006 | Cohort 1H: Normal Hepatic Function | Participants with normal hepatic function received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. | 0 | 6 | 1 | 6 |
| EG007 | Cohort 2H: Mild Hepatic Impairment | Participants with mild hepatic impairment (Child-Pugh class A score of 5-6) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity. | 0 | 6 | 1 | 6 |
| EG008 | Cohort 3H: Moderate Hepatic Impairment | Participants with moderate hepatic impairment (Child-Pugh class B score of 7-9) received TAK-272 40 mg, tablets, orally in fasted state, once on Day 1 of a 6-day treatment period with 2-day follow-up period. The Child-Pugh classification assesses the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, PT or INR, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity. | 0 | 6 | 3 | 6 |
| Gastroduodenal ulcer | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| Dumping syndrome | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| Blood pressure decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
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Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| M-I |
|
TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.
| LS Mean Cohort Ratio (%) |
| 77.04 |
| 2-Sided |
| 95 |
| 50.72 |
| 117.03 |
| Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 206.41 | 2-Sided | 95 | 135.88 | 313.54 | Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 143.11 | 2-Sided | 95 | 94.21 | 217.39 | Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 85.31 | 2-Sided | 95 | 51.03 | 142.61 | Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 131.63 | 2-Sided | 95 | 78.74 | 220.04 | Superiority or Other |
| M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 70.38 | 2-Sided | 95 | 40.42 | 122.53 | Superiority or Other |
| M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 55.03 | 2-Sided | 95 | 31.61 | 95.81 | Superiority or Other |
| M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 125.96 | 2-Sided | 95 | 72.35 | 219.30 | Superiority or Other |
| M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 103.93 | 2-Sided | 95 | 59.70 | 180.95 | Superiority or Other |
| M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 91.97 | 2-Sided | 95 | 49.45 | 171.06 | Superiority or Other |
| M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 139.33 | 2-Sided | 95 | 74.91 | 259.15 | Superiority or Other |
| M-I |
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TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.
| LS Mean Cohort Ratio (%) |
| 118.43 |
| 2-Sided |
| 95 |
| 81.70 |
| 171.68 |
| Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 272.83 | 2-Sided | 95 | 188.21 | 395.50 | Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 184.13 | 2-Sided | 95 | 127.02 | 266.91 | Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 101.64 | 2-Sided | 95 | 69.04 | 149.64 | Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 136.59 | 2-Sided | 95 | 92.78 | 201.09 | Superiority or Other |
| M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 59.17 | 2-Sided | 95 | 33.99 | 102.99 | Superiority or Other |
| M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 97.04 | 2-Sided | 95 | 55.75 | 168.90 | Superiority or Other |
| M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 260.03 | 2-Sided | 95 | 149.39 | 452.60 | Superiority or Other |
| M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 319.06 | 2-Sided | 95 | 183.31 | 555.34 | Superiority or Other |
| M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 130.07 | 2-Sided | 95 | 81.66 | 207.18 | Superiority or Other |
| M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 192.63 | 2-Sided | 95 | 120.94 | 306.83 | Superiority or Other |
TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.
| LS Mean Cohort Ratio (%) |
| 97.39 |
| 2-Sided |
| 95 |
| 64.77 |
| 146.46 |
| Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 111.60 | 2-Sided | 95 | 74.21 | 167.82 | Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 138.79 | 2-Sided | 95 | 92.29 | 208.70 | Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 135.18 | 2-Sided | 95 | 87.91 | 207.87 | Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 323.75 | 2-Sided | 95 | 210.54 | 497.85 | Superiority or Other |
TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.
| LS Mean Cohort Ratio (%) |
| 63.70 |
| 2-Sided |
| 95 |
| 39.73 |
| 102.12 |
| Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 84.45 | 2-Sided | 95 | 52.67 | 135.38 | Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 108.54 | 2-Sided | 95 | 67.70 | 174.01 | Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 113.25 | 2-Sided | 95 | 69.62 | 184.24 | Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 312.89 | 2-Sided | 95 | 192.34 | 509.00 | Superiority or Other |
TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.
| LS Mean Cohort Ratio (%) |
| 98.01 |
| 2-Sided |
| 95 |
| 65.17 |
| 147.41 |
| Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 111.68 | 2-Sided | 95 | 74.25 | 167.96 | Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 139.70 | 2-Sided | 95 | 92.88 | 210.11 | Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 135.08 | 2-Sided | 95 | 87.75 | 207.92 | Superiority or Other |
| TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data. | LS Mean Cohort Ratio (%) | 325.28 | 2-Sided | 95 | 211.32 | 500.70 | Superiority or Other |
| M-I |
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| M-I |
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