Trial Outcomes & Findings for Phase I Open-label Study to Evaluate Pharmacokinetics of TAK-272 in Participants With Renal or Hepatic Impairment (NCT NCT02367872)
NCT ID: NCT02367872
Last Updated: 2017-11-06
Results Overview
COMPLETED
PHASE1
48 participants
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
2017-11-06
Participant Flow
Participants took part in the study at 4 investigative sites in Japan from 1 March 2015 to 10 June 2016.
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).
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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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Overall Study
STARTED
|
6
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6
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6
|
6
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6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I Open-label Study to Evaluate Pharmacokinetics of TAK-272 in Participants With Renal or Hepatic Impairment
Baseline characteristics by cohort
| Measure |
Cohort 1R: Normal Renal Function
n=6 Participants
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.
|
Cohort 2R: Mild Renal Impairment
n=6 Participants
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.
|
Cohort 3R: Moderate Renal Impairment
n=6 Participants
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.
|
Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)
n=6 Participants
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.
|
Cohort 5R: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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.
|
Cohort 1H: Normal Hepatic Function
n=6 Participants
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.
|
Cohort 2H: Mild Hepatic Impairment
n=6 Participants
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.
|
Cohort 3H: Moderate Hepatic Impairment
n=6 Participants
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.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 5.61 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 8.94 • n=7 Participants
|
70.2 years
STANDARD_DEVIATION 5.53 • n=5 Participants
|
69.5 years
STANDARD_DEVIATION 5.89 • n=4 Participants
|
71.2 years
STANDARD_DEVIATION 6.91 • n=21 Participants
|
61.0 years
STANDARD_DEVIATION 5.73 • n=10 Participants
|
61.0 years
STANDARD_DEVIATION 10.41 • n=115 Participants
|
61.5 years
STANDARD_DEVIATION 8.96 • n=6 Participants
|
65.0 years
STANDARD_DEVIATION 8.23 • n=6 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
14 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
34 Participants
n=6 Participants
|
|
Region of Enrollment
Japan
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
48 Participants
n=6 Participants
|
|
Height
|
157.3 centimeter (cm)
STANDARD_DEVIATION 10.91 • n=5 Participants
|
163.7 centimeter (cm)
STANDARD_DEVIATION 9.18 • n=7 Participants
|
167.7 centimeter (cm)
STANDARD_DEVIATION 5.32 • n=5 Participants
|
159.0 centimeter (cm)
STANDARD_DEVIATION 8.63 • n=4 Participants
|
160.8 centimeter (cm)
STANDARD_DEVIATION 5.56 • n=21 Participants
|
161.2 centimeter (cm)
STANDARD_DEVIATION 5.64 • n=10 Participants
|
160.0 centimeter (cm)
STANDARD_DEVIATION 10.20 • n=115 Participants
|
161.5 centimeter (cm)
STANDARD_DEVIATION 11.40 • n=6 Participants
|
161.4 centimeter (cm)
STANDARD_DEVIATION 8.54 • n=6 Participants
|
|
Weight
|
57.58 kilogram (kg)
STANDARD_DEVIATION 6.328 • n=5 Participants
|
59.80 kilogram (kg)
STANDARD_DEVIATION 11.726 • n=7 Participants
|
69.87 kilogram (kg)
STANDARD_DEVIATION 5.654 • n=5 Participants
|
56.48 kilogram (kg)
STANDARD_DEVIATION 9.392 • n=4 Participants
|
60.83 kilogram (kg)
STANDARD_DEVIATION 6.982 • n=21 Participants
|
62.25 kilogram (kg)
STANDARD_DEVIATION 6.275 • n=10 Participants
|
65.08 kilogram (kg)
STANDARD_DEVIATION 11.760 • n=115 Participants
|
69.73 kilogram (kg)
STANDARD_DEVIATION 23.171 • n=6 Participants
|
62.70 kilogram (kg)
STANDARD_DEVIATION 11.674 • n=6 Participants
|
|
Body Mass Index
|
23.42 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.807 • n=5 Participants
|
22.12 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.289 • n=7 Participants
|
24.88 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.082 • n=5 Participants
|
22.22 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.588 • n=4 Participants
|
23.62 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.242 • n=21 Participants
|
24.03 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.935 • n=10 Participants
|
25.33 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.389 • n=115 Participants
|
26.03 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 5.581 • n=6 Participants
|
23.96 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.303 • n=6 Participants
|
|
Smoking Classification
Never smoked
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
20 Participants
n=6 Participants
|
|
Smoking Classification
Current smoker
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
10 Participants
n=6 Participants
|
|
Smoking Classification
Ex-smoker
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
18 Participants
n=6 Participants
|
|
Alcohol Classification
Drinks every day
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
|
Alcohol Classification
Drinks a few days per week
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
9 Participants
n=6 Participants
|
|
Alcohol Classification
Drinks a few days per month
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
|
Alcohol Classification
Never drinks
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
26 Participants
n=6 Participants
|
|
Caffeine Classification
Yes
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
38 Participants
n=6 Participants
|
|
Caffeine Classification
No
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
10 Participants
n=6 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR)
|
114.8 mL/min/1.73 m^2
STANDARD_DEVIATION 26.03 • n=5 Participants
|
80.7 mL/min/1.73 m^2
STANDARD_DEVIATION 17.70 • n=7 Participants
|
54.8 mL/min/1.73 m^2
STANDARD_DEVIATION 9.50 • n=5 Participants
|
16.3 mL/min/1.73 m^2
STANDARD_DEVIATION 7.61 • n=4 Participants
|
4.5 mL/min/1.73 m^2
STANDARD_DEVIATION 0.55 • n=21 Participants
|
115.2 mL/min/1.73 m^2
STANDARD_DEVIATION 14.55 • n=10 Participants
|
93.7 mL/min/1.73 m^2
STANDARD_DEVIATION 21.63 • n=115 Participants
|
100.8 mL/min/1.73 m^2
STANDARD_DEVIATION 16.49 • n=6 Participants
|
72.6 mL/min/1.73 m^2
STANDARD_DEVIATION 43.41 • n=6 Participants
|
|
Alpha1 Acid Glycoprotein (AGP)
|
64.97 milligram per deciliter (mg/dL)
STANDARD_DEVIATION 12.065 • n=5 Participants
|
48.65 milligram per deciliter (mg/dL)
STANDARD_DEVIATION 4.809 • n=7 Participants
|
70.30 milligram per deciliter (mg/dL)
STANDARD_DEVIATION 14.936 • n=5 Participants
|
114.45 milligram per deciliter (mg/dL)
STANDARD_DEVIATION 25.029 • n=4 Participants
|
82.77 milligram per deciliter (mg/dL)
STANDARD_DEVIATION 7.104 • n=21 Participants
|
55.80 milligram per deciliter (mg/dL)
STANDARD_DEVIATION 17.694 • n=10 Participants
|
51.18 milligram per deciliter (mg/dL)
STANDARD_DEVIATION 16.328 • n=115 Participants
|
41.12 milligram per deciliter (mg/dL)
STANDARD_DEVIATION 20.282 • n=6 Participants
|
66.15 milligram per deciliter (mg/dL)
STANDARD_DEVIATION 26.757 • n=6 Participants
|
PRIMARY outcome
Timeframe: 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-dosePopulation: 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.
Outcome measures
| Measure |
Cohort 1R: Normal Renal Function
n=6 Participants
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.
|
Cohort 2R: Mild Renal Impairment
n=6 Participants
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.
|
Cohort 3R: Moderate Renal Impairment
n=6 Participants
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.
|
Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)
n=6 Participants
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.
|
Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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).
|
Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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.
|
Cohort 1H: Normal Hepatic Function
n=6 Participants
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.
|
Cohort 2H: Mild Hepatic Impairment
n=6 Participants
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.
|
Cohort 3H: Moderate Hepatic Impairment
n=6 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
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
TAK-272F
|
2951 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 391.70
|
1507 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 952.72
|
3481 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 797.67
|
8053 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 2964.7
|
4579 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 1091.2
|
5409 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 1343.0
|
2269 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 366.43
|
2307 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 750.08
|
3085 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 1551.3
|
|
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
M-I
|
50.66 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 27.097
|
31.58 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 13.765
|
47.22 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 18.319
|
138.9 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 89.619
|
104.3 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 20.684
|
132.3 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 40.166
|
33.95 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 13.432
|
38.18 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 14.860
|
60.01 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 27.427
|
PRIMARY outcome
Timeframe: 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-dosePopulation: 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.
Outcome measures
| Measure |
Cohort 1R: Normal Renal Function
n=6 Participants
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.
|
Cohort 2R: Mild Renal Impairment
n=6 Participants
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.
|
Cohort 3R: Moderate Renal Impairment
n=6 Participants
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.
|
Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)
n=6 Participants
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.
|
Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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).
|
Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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.
|
Cohort 1H: Normal Hepatic Function
n=6 Participants
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.
|
Cohort 2H: Mild Hepatic Impairment
n=6 Participants
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.
|
Cohort 3H: Moderate Hepatic Impairment
n=6 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-272F and Its Metabolite M-I
TAK-272F
|
753.5 nanogram per milliliter (ng/mL)
Standard Deviation 211.81
|
432.2 nanogram per milliliter (ng/mL)
Standard Deviation 248.57
|
580.5 nanogram per milliliter (ng/mL)
Standard Deviation 312.90
|
1555 nanogram per milliliter (ng/mL)
Standard Deviation 303.45
|
1061 nanogram per milliliter (ng/mL)
Standard Deviation 222.54
|
1078 nanogram per milliliter (ng/mL)
Standard Deviation 417.38
|
522.8 nanogram per milliliter (ng/mL)
Standard Deviation 111.65
|
446.0 nanogram per milliliter (ng/mL)
Standard Deviation 198.78
|
688.1 nanogram per milliliter (ng/mL)
Standard Deviation 339.69
|
|
Cmax: Maximum Observed Plasma Concentration for TAK-272F and Its Metabolite M-I
M-I
|
20.08 nanogram per milliliter (ng/mL)
Standard Deviation 11.909
|
14.13 nanogram per milliliter (ng/mL)
Standard Deviation 7.0952
|
11.05 nanogram per milliliter (ng/mL)
Standard Deviation 7.9919
|
25.30 nanogram per milliliter (ng/mL)
Standard Deviation 13.442
|
19.86 nanogram per milliliter (ng/mL)
Standard Deviation 5.6056
|
20.87 nanogram per milliliter (ng/mL)
Standard Deviation 3.5431
|
12.45 nanogram per milliliter (ng/mL)
Standard Deviation 8.8158
|
11.45 nanogram per milliliter (ng/mL)
Standard Deviation 6.2582
|
17.34 nanogram per milliliter (ng/mL)
Standard Deviation 6.6026
|
PRIMARY outcome
Timeframe: 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-dosePopulation: 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.
Outcome measures
| Measure |
Cohort 1R: Normal Renal Function
n=6 Participants
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.
|
Cohort 2R: Mild Renal Impairment
n=6 Participants
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.
|
Cohort 3R: Moderate Renal Impairment
n=6 Participants
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.
|
Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)
n=6 Participants
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.
|
Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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).
|
Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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.
|
Cohort 1H: Normal Hepatic Function
n=6 Participants
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.
|
Cohort 2H: Mild Hepatic Impairment
n=6 Participants
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.
|
Cohort 3H: Moderate Hepatic Impairment
n=6 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-272F and Its Metabolite M-I
TAK-272F
|
2971 ng*hr/mL
Standard Deviation 393.33
|
1527 ng*hr/mL
Standard Deviation 953.59
|
3519 ng*hr/mL
Standard Deviation 812.10
|
8106 ng*hr/mL
Standard Deviation 3004.0
|
4647 ng*hr/mL
Standard Deviation 1101.8
|
5471 ng*hr/mL
Standard Deviation 1342.1
|
2289 ng*hr/mL
Standard Deviation 368.39
|
2326 ng*hr/mL
Standard Deviation 746.40
|
3126 ng*hr/mL
Standard Deviation 1575.2
|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-272F and Its Metabolite M-I
M-I
|
62.32 ng*hr/mL
Standard Deviation 32.579
|
36.87 ng*hr/mL
Standard Deviation 15.778
|
60.47 ng*hr/mL
Standard Deviation 21.246
|
162.0 ng*hr/mL
Standard Deviation 99.759
|
129.6 ng*hr/mL
Standard Deviation 23.022
|
198.8 ng*hr/mL
Standard Deviation 95.110
|
38.84 ng*hr/mL
Standard Deviation 15.615
|
50.52 ng*hr/mL
Standard Deviation 16.916
|
74.82 ng*hr/mL
Standard Deviation 31.470
|
PRIMARY outcome
Timeframe: 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-dosePopulation: 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.
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.
Outcome measures
| Measure |
Cohort 1R: Normal Renal Function
n=6 Participants
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.
|
Cohort 2R: Mild Renal Impairment
n=6 Participants
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.
|
Cohort 3R: Moderate Renal Impairment
n=6 Participants
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.
|
Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)
n=6 Participants
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.
|
Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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).
|
Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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.
|
Cohort 1H: Normal Hepatic Function
n=6 Participants
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.
|
Cohort 2H: Mild Hepatic Impairment
n=6 Participants
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.
|
Cohort 3H: Moderate Hepatic Impairment
n=6 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
AUClast,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration for TAK-272F
|
138.7 ng*hr/mL
Standard Deviation 72.422
|
83.51 ng*hr/mL
Standard Deviation 40.288
|
135.0 ng*hr/mL
Standard Deviation 16.105
|
154.7 ng*hr/mL
Standard Deviation 55.009
|
162.9 ng*hr/mL
Standard Deviation 40.127
|
192.4 ng*hr/mL
Standard Deviation 55.731
|
107.7 ng*hr/mL
Standard Deviation 17.583
|
145.5 ng*hr/mL
Standard Deviation 82.297
|
348.5 ng*hr/mL
Standard Deviation 102.16
|
PRIMARY outcome
Timeframe: 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-dosePopulation: 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.
Cmax,u is the peak unbound plasma concentration of a drug after administration, obtained directly from the unbound plasma concentration-time curve.
Outcome measures
| Measure |
Cohort 1R: Normal Renal Function
n=6 Participants
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.
|
Cohort 2R: Mild Renal Impairment
n=6 Participants
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.
|
Cohort 3R: Moderate Renal Impairment
n=6 Participants
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.
|
Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)
n=6 Participants
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.
|
Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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).
|
Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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.
|
Cohort 1H: Normal Hepatic Function
n=6 Participants
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.
|
Cohort 2H: Mild Hepatic Impairment
n=6 Participants
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.
|
Cohort 3H: Moderate Hepatic Impairment
n=6 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cmax,u: Maximum Unbound Plasma Concentration for TAK-272F
|
35.38 ng/mL
Standard Deviation 20.053
|
23.92 ng/mL
Standard Deviation 12.222
|
22.54 ng/mL
Standard Deviation 10.180
|
29.88 ng/mL
Standard Deviation 5.8353
|
37.76 ng/mL
Standard Deviation 11.566
|
38.41 ng/mL
Standard Deviation 22.002
|
24.82 ng/mL
Standard Deviation 7.1225
|
28.11 ng/mL
Standard Deviation 17.659
|
77.66 ng/mL
Standard Deviation 23.421
|
PRIMARY outcome
Timeframe: 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-dosePopulation: 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.
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.
Outcome measures
| Measure |
Cohort 1R: Normal Renal Function
n=6 Participants
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.
|
Cohort 2R: Mild Renal Impairment
n=6 Participants
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.
|
Cohort 3R: Moderate Renal Impairment
n=6 Participants
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.
|
Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)
n=6 Participants
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.
|
Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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).
|
Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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.
|
Cohort 1H: Normal Hepatic Function
n=6 Participants
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.
|
Cohort 2H: Mild Hepatic Impairment
n=6 Participants
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.
|
Cohort 3H: Moderate Hepatic Impairment
n=6 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC∞,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for TAK-272F
|
139.3 ng*hr/mL
Standard Deviation 73.070
|
84.51 ng*hr/mL
Standard Deviation 40.355
|
136.5 ng*hr/mL
Standard Deviation 16.537
|
155.5 ng*hr/mL
Standard Deviation 56.099
|
165.1 ng*hr/mL
Standard Deviation 39.885
|
194.6 ng*hr/mL
Standard Deviation 55.238
|
108.5 ng*hr/mL
Standard Deviation 17.885
|
146.5 ng*hr/mL
Standard Deviation 82.800
|
352.9 ng*hr/mL
Standard Deviation 103.09
|
PRIMARY outcome
Timeframe: 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-dosePopulation: 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.
Outcome measures
| Measure |
Cohort 1R: Normal Renal Function
n=6 Participants
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.
|
Cohort 2R: Mild Renal Impairment
n=6 Participants
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.
|
Cohort 3R: Moderate Renal Impairment
n=6 Participants
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.
|
Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)
n=6 Participants
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.
|
Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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).
|
Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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.
|
Cohort 1H: Normal Hepatic Function
n=6 Participants
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.
|
Cohort 2H: Mild Hepatic Impairment
n=6 Participants
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.
|
Cohort 3H: Moderate Hepatic Impairment
n=6 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-272F and Its Metabolite M-I
TAK-272F
|
0.7500 hour
Interval 0.5 to 1.5
|
0.5000 hour
Interval 0.5 to 1.5
|
1.000 hour
Interval 0.5 to 3.0
|
1.000 hour
Interval 0.5 to 1.5
|
0.7250 hour
Interval 0.417 to 0.95
|
0.9815 hour
Interval 0.45 to 1.43
|
1.000 hour
Interval 0.5 to 1.0
|
0.5170 hour
Interval 0.5 to 1.0
|
0.5000 hour
Interval 0.5 to 0.5
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-272F and Its Metabolite M-I
M-I
|
0.7500 hour
Interval 0.5 to 1.0
|
0.7500 hour
Interval 0.5 to 1.5
|
0.7500 hour
Interval 0.5 to 1.5
|
1.000 hour
Interval 0.5 to 1.5
|
0.7250 hour
Interval 0.417 to 0.95
|
0.9250 hour
Interval 0.45 to 1.42
|
1.000 hour
Interval 0.5 to 1.0
|
1.000 hour
Interval 0.5 to 1.0
|
0.5000 hour
Interval 0.5 to 1.0
|
PRIMARY outcome
Timeframe: 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-dosePopulation: 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.
Outcome measures
| Measure |
Cohort 1R: Normal Renal Function
n=6 Participants
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.
|
Cohort 2R: Mild Renal Impairment
n=6 Participants
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.
|
Cohort 3R: Moderate Renal Impairment
n=6 Participants
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.
|
Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)
n=6 Participants
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.
|
Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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).
|
Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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.
|
Cohort 1H: Normal Hepatic Function
n=6 Participants
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.
|
Cohort 2H: Mild Hepatic Impairment
n=6 Participants
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.
|
Cohort 3H: Moderate Hepatic Impairment
n=6 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) for TAK-272F
|
13.57 liter per hour (L/hr)
Standard Deviation 1.8565 • Interval 0.5 to 1.5
|
28.05 liter per hour (L/hr)
Standard Deviation 9.3870 • Interval 0.5 to 1.5
|
11.63 liter per hour (L/hr)
Standard Deviation 2.6246 • Interval 0.5 to 3.0
|
5.290 liter per hour (L/hr)
Standard Deviation 2.3246 • Interval 0.5 to 1.5
|
8.955 liter per hour (L/hr)
Standard Deviation 3.0987
|
7.535 liter per hour (L/hr)
Standard Deviation 2.1430
|
17.68 liter per hour (L/hr)
Standard Deviation 3.1682
|
17.83 liter per hour (L/hr)
Standard Deviation 5.0433
|
13.70 liter per hour (L/hr)
Standard Deviation 5.1084
|
PRIMARY outcome
Timeframe: 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-dosePopulation: 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.
CLu/F is the apparent clearance for unbound drug after extravascular administration of TAK-272.
Outcome measures
| Measure |
Cohort 1R: Normal Renal Function
n=6 Participants
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.
|
Cohort 2R: Mild Renal Impairment
n=6 Participants
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.
|
Cohort 3R: Moderate Renal Impairment
n=6 Participants
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.
|
Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)
n=6 Participants
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.
|
Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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).
|
Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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.
|
Cohort 1H: Normal Hepatic Function
n=6 Participants
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.
|
Cohort 2H: Mild Hepatic Impairment
n=6 Participants
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.
|
Cohort 3H: Moderate Hepatic Impairment
n=6 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
CLu/F: Apparent Clearance for Unbound Drug After Extravascular Administration for TAK-272F
|
315.7 L/hr
Standard Deviation 152.20 • Interval 0.5 to 1.0
|
500.8 L/hr
Standard Deviation 163.96 • Interval 0.5 to 1.5
|
294.7 L/hr
Standard Deviation 34.938 • Interval 0.5 to 1.5
|
271.5 L/hr
Standard Deviation 100.55 • Interval 0.5 to 1.5
|
247.8 L/hr
Standard Deviation 60.579
|
210.2 L/hr
Standard Deviation 46.940
|
372.8 L/hr
Standard Deviation 66.949
|
301.8 L/hr
Standard Deviation 139.68
|
117.3 L/hr
Standard Deviation 33.417
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose and at multiple time points (4, 8, 12, 24, 36, 48, 72 hours post dose; up to 72 hours) post-dosePopulation: 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.
Urinary excretion ratio (percentage \[%\] of dose) of TAK-272 and its metabolite M-I in urine was calculated for each participant.
Outcome measures
| Measure |
Cohort 1R: Normal Renal Function
n=6 Participants
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.
|
Cohort 2R: Mild Renal Impairment
n=6 Participants
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.
|
Cohort 3R: Moderate Renal Impairment
n=5 Participants
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.
|
Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)
n=6 Participants
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.
|
Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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).
|
Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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.
|
Cohort 1H: Normal Hepatic Function
n=6 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
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
TAK-272F
|
13.227 percentage of dose
Standard Deviation 1.3321
|
10.710 percentage of dose
Standard Deviation 3.2216
|
12.820 percentage of dose
Standard Deviation 2.6621
|
4.947 percentage of dose
Standard Deviation 3.3152
|
13.980 percentage of dose
Standard Deviation 5.0380
|
15.205 percentage of dose
Standard Deviation 2.6194
|
21.222 percentage of dose
Standard Deviation 4.9429
|
—
|
—
|
|
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
M-I
|
0.558 percentage of dose
Standard Deviation 0.2596
|
0.477 percentage of dose
Standard Deviation 0.2017
|
0.284 percentage of dose
Standard Deviation 0.0598
|
0.072 percentage of dose
Standard Deviation 0.0462
|
0.453 percentage of dose
Standard Deviation 0.1515
|
0.557 percentage of dose
Standard Deviation 0.1672
|
0.788 percentage of dose
Standard Deviation 0.3352
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
Plasma protein binding rate was the percentage of unbound fraction of TAK-272F in plasma protein.
Outcome measures
| Measure |
Cohort 1R: Normal Renal Function
n=6 Participants
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.
|
Cohort 2R: Mild Renal Impairment
n=6 Participants
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.
|
Cohort 3R: Moderate Renal Impairment
n=6 Participants
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.
|
Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)
n=6 Participants
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.
|
Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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).
|
Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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.
|
Cohort 1H: Normal Hepatic Function
n=6 Participants
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.
|
Cohort 2H: Mild Hepatic Impairment
n=6 Participants
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Plasma Protein Binding Rate of TAK-272F in Cohorts 1R, 2R, 3R, 4R, 5R, 1H, 2H and 3H
|
5.298 % of unbound fraction of TAK-272F
Standard Deviation 3.1279
|
5.597 % of unbound fraction of TAK-272F
Standard Deviation 0.88260
|
3.970 % of unbound fraction of TAK-272F
Standard Deviation 0.88091
|
1.948 % of unbound fraction of TAK-272F
Standard Deviation 0.35549
|
3.598 % of unbound fraction of TAK-272F
Standard Deviation 0.59734
|
4.800 % of unbound fraction of TAK-272F
Standard Deviation 0.77095
|
7.177 % of unbound fraction of TAK-272F
Standard Deviation 4.0484
|
12.82 % of unbound fraction of TAK-272F
Standard Deviation 6.5481
|
—
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose, up to 6 hours post-dosePopulation: 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.
Excretion ratio (% of dose) of TAK-272F in dialysis fluid was calculated for each participant.
Outcome measures
| Measure |
Cohort 1R: Normal Renal Function
n=6 Participants
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.
|
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.
|
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.
|
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.
|
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).
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Excretion Ratio of TAK-272F in Dialysate in Cohort 5R
|
3.110 percentage of dose
Standard Deviation 0.8911
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 8 of each CohortPopulation: The safety analysis set included all participants who were treated with at least 1 dose of study drug.
Outcome measures
| Measure |
Cohort 1R: Normal Renal Function
n=6 Participants
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.
|
Cohort 2R: Mild Renal Impairment
n=6 Participants
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.
|
Cohort 3R: Moderate Renal Impairment
n=6 Participants
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.
|
Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)
n=6 Participants
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.
|
Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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).
|
Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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.
|
Cohort 1H: Normal Hepatic Function
n=6 Participants
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.
|
Cohort 2H: Mild Hepatic Impairment
n=6 Participants
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.
|
Cohort 3H: Moderate Hepatic Impairment
n=6 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 8 of each CohortPopulation: The safety analysis set included all participants who were treated with at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Cohort 1R: Normal Renal Function
n=6 Participants
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.
|
Cohort 2R: Mild Renal Impairment
n=6 Participants
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.
|
Cohort 3R: Moderate Renal Impairment
n=6 Participants
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.
|
Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)
n=6 Participants
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.
|
Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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).
|
Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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.
|
Cohort 1H: Normal Hepatic Function
n=6 Participants
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.
|
Cohort 2H: Mild Hepatic Impairment
n=6 Participants
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.
|
Cohort 3H: Moderate Hepatic Impairment
n=6 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAE Related to Vital Signs
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 8 of each CohortPopulation: The safety analysis set included all participants who were treated with at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Cohort 1R: Normal Renal Function
n=6 Participants
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.
|
Cohort 2R: Mild Renal Impairment
n=6 Participants
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.
|
Cohort 3R: Moderate Renal Impairment
n=6 Participants
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.
|
Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)
n=6 Participants
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.
|
Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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).
|
Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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.
|
Cohort 1H: Normal Hepatic Function
n=6 Participants
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.
|
Cohort 2H: Mild Hepatic Impairment
n=6 Participants
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.
|
Cohort 3H: Moderate Hepatic Impairment
n=6 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAE Related to Body Weight
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 8 of each CohortPopulation: The safety analysis set included all participants who were treated with at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Cohort 1R: Normal Renal Function
n=6 Participants
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.
|
Cohort 2R: Mild Renal Impairment
n=6 Participants
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.
|
Cohort 3R: Moderate Renal Impairment
n=6 Participants
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.
|
Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)
n=6 Participants
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.
|
Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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).
|
Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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.
|
Cohort 1H: Normal Hepatic Function
n=6 Participants
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.
|
Cohort 2H: Mild Hepatic Impairment
n=6 Participants
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.
|
Cohort 3H: Moderate Hepatic Impairment
n=6 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECG)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 8 of each CohortPopulation: The safety analysis set included all participants who were treated with at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Cohort 1R: Normal Renal Function
n=6 Participants
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.
|
Cohort 2R: Mild Renal Impairment
n=6 Participants
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.
|
Cohort 3R: Moderate Renal Impairment
n=6 Participants
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.
|
Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)
n=6 Participants
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.
|
Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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).
|
Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)
n=6 Participants
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.
|
Cohort 1H: Normal Hepatic Function
n=6 Participants
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.
|
Cohort 2H: Mild Hepatic Impairment
n=6 Participants
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.
|
Cohort 3H: Moderate Hepatic Impairment
n=6 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAE Related to Laboratory Tests
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
Adverse Events
Cohort 1R: Normal Renal Function
Cohort 2R: Mild Renal Impairment
Cohort 3R: Moderate Renal Impairment
Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)
Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)
Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)
Cohort 1H: Normal Hepatic Function
Cohort 2H: Mild Hepatic Impairment
Cohort 3H: Moderate Hepatic Impairment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1R: Normal Renal Function
n=6 participants at risk
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.
|
Cohort 2R: Mild Renal Impairment
n=6 participants at risk
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.
|
Cohort 3R: Moderate Renal Impairment
n=6 participants at risk
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.
|
Cohort 4R: Severe or End-stage Renal Failure(Non-hemodialysis)
n=6 participants at risk
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.
|
Cohort 5R-Part 1: End-stage Renal Failure (Hemodialysis)
n=6 participants at risk
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).
|
Cohort 5R-Part 2: End-stage Renal Failure (Hemodialysis)
n=6 participants at risk
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.
|
Cohort 1H: Normal Hepatic Function
n=6 participants at risk
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.
|
Cohort 2H: Mild Hepatic Impairment
n=6 participants at risk
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.
|
Cohort 3H: Moderate Hepatic Impairment
n=6 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
|
Injury, poisoning and procedural complications
Dumping syndrome
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER