Trial Outcomes & Findings for A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954 (NCT NCT03296787)
NCT ID: NCT03296787
Last Updated: 2020-08-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion
Results posted on
2020-08-25
Participant Flow
Participants took part in the study at 4 investigative sites in Czech Republic and Hungary from 21 November 2017 to 09 August 2019.
Participants with normal renal function and renal impairment were enrolled in 1 of the 4 groups: A (healthy), C (moderate), D (severe), and E (end-stage renal disease \[ESRD\]) to receive TAK-954 0.2 milligram (mg). Based on available safety and pharmacokinetics (PK) data from Group C, participants were not enrolled in Group B (mild).
Participant milestones
| Measure |
Group A: Healthy Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 milligram per kilogram \[mg/kg\], intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
|
Group C: Moderate Renal Impairment
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 mg/kg, intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
|
Group D: Severe Renal Impairment Not Requiring Dialysis
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
|
Group E: ESRD Requiring Dialysis
TAK-954 0.2 mg, infusion, intravenously in fasted state, 1 hour after the end of dialysis, once on Day 1 of a 6-day Period 1, followed by a minimum 13-day washout period, further followed by TAK-954 0.2 mg, infusion, intravenously in fasted state, 2 hours before the start of dialysis, once on Day 1 of a 4-day Period 2 in participants with ESRD requiring dialysis.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
9
|
7
|
|
Overall Study
COMPLETED
|
8
|
8
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954
Baseline characteristics by cohort
| Measure |
Group A: Healthy Participants
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 milligram per kilogram \[mg/kg\], intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
|
Group C: Moderate Renal Impairment
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 mg/kg, intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
|
Group D: Severe Renal Impairment Not Requiring Dialysis
n=9 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
|
Group E: ESRD Requiring Dialysis
n=7 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, 1 hour after the end of dialysis, once on Day 1 of a 6-day Period 1, followed by a minimum 13-day washout period, further followed by TAK-954 0.2 mg, infusion, intravenously in fasted state, 2 hours before the start of dialysis, once on Day 1 of a 4-day Period 2 in participants with ESRD requiring dialysis.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57.0 years
STANDARD_DEVIATION 15.62 • n=5 Participants
|
70.6 years
STANDARD_DEVIATION 3.50 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 11.03 • n=5 Participants
|
52.6 years
STANDARD_DEVIATION 10.06 • n=4 Participants
|
60.9 years
STANDARD_DEVIATION 12.38 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Czech Republic
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Weight
|
79.95 kilogram (kg)
STANDARD_DEVIATION 7.773 • n=5 Participants
|
75.95 kilogram (kg)
STANDARD_DEVIATION 13.035 • n=7 Participants
|
76.22 kilogram (kg)
STANDARD_DEVIATION 14.457 • n=5 Participants
|
82.39 kilogram (kg)
STANDARD_DEVIATION 7.006 • n=4 Participants
|
78.43 kilogram (kg)
STANDARD_DEVIATION 11.072 • n=21 Participants
|
|
Body Mass Index (BMI)
|
26.88 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.051 • n=5 Participants
|
26.25 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.166 • n=7 Participants
|
27.33 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.272 • n=5 Participants
|
28.14 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.673 • n=4 Participants
|
27.13 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.765 • n=21 Participants
|
|
Height
|
173.25 centimeter (cm)
STANDARD_DEVIATION 9.706 • n=5 Participants
|
170.25 centimeter (cm)
STANDARD_DEVIATION 9.543 • n=7 Participants
|
166.89 centimeter (cm)
STANDARD_DEVIATION 9.519 • n=5 Participants
|
171.00 centimeter (cm)
STANDARD_DEVIATION 6.976 • n=4 Participants
|
170.22 centimeter (cm)
STANDARD_DEVIATION 8.965 • n=21 Participants
|
|
Creatine Clearance
|
107.11 milliliter per minute (mL/min)
STANDARD_DEVIATION 23.417 • n=5 Participants
|
46.20 milliliter per minute (mL/min)
STANDARD_DEVIATION 10.767 • n=7 Participants
|
23.20 milliliter per minute (mL/min)
STANDARD_DEVIATION 6.385 • n=5 Participants
|
10.54 milliliter per minute (mL/min)
STANDARD_DEVIATION 2.504 • n=4 Participants
|
47.16 milliliter per minute (mL/min)
STANDARD_DEVIATION 39.484 • n=21 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR)
|
89.93 milliliter per minute/1.73 square meter
STANDARD_DEVIATION 13.779 • n=5 Participants
|
41.68 milliliter per minute/1.73 square meter
STANDARD_DEVIATION 11.527 • n=7 Participants
|
18.13 milliliter per minute/1.73 square meter
STANDARD_DEVIATION 8.648 • n=5 Participants
|
6.93 milliliter per minute/1.73 square meter
STANDARD_DEVIATION 2.757 • n=4 Participants
|
39.52 milliliter per minute/1.73 square meter
STANDARD_DEVIATION 33.514 • n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusionPopulation: The PK set consisted of all participants who were enrolled and received at least 1 dose of trial drug and had at least 1 measurable TAK-954 plasma concentration. The outcome measure (OM) was planned to be assessed for the groups where blood samples were collected before the start of TAK-954 infusion and through 120 hours post-infusion.
Outcome measures
| Measure |
Group A: Healthy Participants
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 milligram per kilogram \[mg/kg\], intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
|
Group C: Moderate Renal Impairment
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 mg/kg, intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
|
Group D: Severe Renal Impairment Not Requiring Dialysis
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
|
|---|---|---|---|
|
Groups A, C and D; Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free)
TAK-954 (Total)
|
2.623 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 12.8
|
2.536 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 23.2
|
2.660 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 17.6
|
|
Groups A, C and D; Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free)
TAK-954 (Free)
|
0.1270 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 29.2
|
0.1282 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 22.5
|
0.1572 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 21.7
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at multiple time points (up to 72 hours) post-infusionPopulation: The PK set consisted of all participants who were enrolled and received at least 1 dose of trial drug and had at least 1 measurable TAK-954 plasma concentration. The OM was planned to be assessed for the groups where blood samples were collected before the start of TAK-954 infusion and through 120 hours post-infusion.
Outcome measures
| Measure |
Group A: Healthy Participants
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 milligram per kilogram \[mg/kg\], intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
|
Group C: Moderate Renal Impairment
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 mg/kg, intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
|
Group D: Severe Renal Impairment Not Requiring Dialysis
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
|
|---|---|---|---|
|
Groups A, C and D; AUC(0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for TAK-954 (Free and Total)
TAK-954 (Total)
|
22.25 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 19.1
|
24.91 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 22.9
|
28.62 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 18.1
|
|
Groups A, C and D; AUC(0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for TAK-954 (Free and Total)
TAK-954 (Free)
|
1.078 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 25.7
|
1.259 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 25.1
|
1.690 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 25.9
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusionPopulation: The PK set consisted of all participants who were enrolled and received at least 1 dose of trial drug and had at least 1 measurable TAK-954 plasma concentration. The OM was planned to be assessed for the groups where blood samples were collected before the start of TAK-954 infusion and through 120 hours post-infusion.
Outcome measures
| Measure |
Group A: Healthy Participants
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 milligram per kilogram \[mg/kg\], intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
|
Group C: Moderate Renal Impairment
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 mg/kg, intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
|
Group D: Severe Renal Impairment Not Requiring Dialysis
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
|
|---|---|---|---|
|
Groups A, C and D; AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 (Free and Total)
TAK-954 (Total)
|
24.39 h*ng/mL
Geometric Coefficient of Variation 17.7
|
30.00 h*ng/mL
Geometric Coefficient of Variation 20.0
|
34.28 h*ng/mL
Geometric Coefficient of Variation 19.3
|
|
Groups A, C and D; AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 (Free and Total)
TAK-954 (Free)
|
1.184 h*ng/mL
Geometric Coefficient of Variation 26.8
|
1.516 h*ng/mL
Geometric Coefficient of Variation 24.3
|
2.025 h*ng/mL
Geometric Coefficient of Variation 26.7
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusionPopulation: PK set:participants who enrolled and received at least 1 dose of trial drug and had at least 1 measurable TAK-954 plasma concentration. Here,"overall number of participants analyzed": participants who were evaluable for this OM. OM was planned to be assessed in groups where blood samples collected pre-TAK-954 infusion up to 120 hours post-infusion.
Outcome measures
| Measure |
Group A: Healthy Participants
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 milligram per kilogram \[mg/kg\], intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
|
Group C: Moderate Renal Impairment
n=7 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 mg/kg, intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
|
Group D: Severe Renal Impairment Not Requiring Dialysis
n=7 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
|
|---|---|---|---|
|
Groups A, C and D; AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 (Free and Total)
TAK-954 (Total)
|
25.43 h*ng/mL
Geometric Coefficient of Variation 16.8
|
34.90 h*ng/mL
Geometric Coefficient of Variation 16.2
|
38.59 h*ng/mL
Geometric Coefficient of Variation 23.9
|
|
Groups A, C and D; AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 (Free and Total)
TAK-954 (Free)
|
1.234 h*ng/mL
Geometric Coefficient of Variation 28.4
|
1.749 h*ng/mL
Geometric Coefficient of Variation 24.8
|
2.320 h*ng/mL
Geometric Coefficient of Variation 29.7
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusionPopulation: The PK set consisted of all participants who were enrolled and received at least 1 dose of trial drug and had at least 1 measurable TAK-954 plasma concentration.
Outcome measures
| Measure |
Group A: Healthy Participants
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 milligram per kilogram \[mg/kg\], intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
|
Group C: Moderate Renal Impairment
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 mg/kg, intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
|
Group D: Severe Renal Impairment Not Requiring Dialysis
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
|
|---|---|---|---|
|
Groups A, C and D; Ae: Amount of TAK-954 Excreted in Urine
|
0.03797 milligram (mg)
Standard Deviation 0.011633
|
0.01763 milligram (mg)
Standard Deviation 0.0087713
|
0.01190 milligram (mg)
Standard Deviation 0.0091124
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusionPopulation: The PK set consisted of all participants who were enrolled and received at least 1 dose of trial drug and had at least 1 measurable TAK-954 plasma concentration. Here, "overall number of participants analyzed" are the participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Group A: Healthy Participants
n=5 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 milligram per kilogram \[mg/kg\], intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
|
Group C: Moderate Renal Impairment
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 mg/kg, intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
|
Group D: Severe Renal Impairment Not Requiring Dialysis
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
|
|---|---|---|---|
|
Group E; Ae: Amount of TAK-954 Excreted in Urine in Period 1
|
0.0003489 mg
Standard Deviation 0.00021788
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusionPopulation: The PK set consisted of all participants who were enrolled and received at least 1 dose of trial drug and had at least 1 measurable TAK-954 plasma concentration. Here, "overall number of participants analyzed" are the participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Group A: Healthy Participants
n=4 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 milligram per kilogram \[mg/kg\], intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
|
Group C: Moderate Renal Impairment
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 mg/kg, intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
|
Group D: Severe Renal Impairment Not Requiring Dialysis
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
|
|---|---|---|---|
|
Group E; Ae: Amount of TAK-954 Excreted in Urine in Period 2
|
0.001240 mg
Standard Deviation 0.00062000
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusionPopulation: The PK set consisted of all participants who were enrolled and received at least 1 dose of trial drug and had at least 1 measurable TAK-954 plasma concentration.
Outcome measures
| Measure |
Group A: Healthy Participants
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 milligram per kilogram \[mg/kg\], intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
|
Group C: Moderate Renal Impairment
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 mg/kg, intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
|
Group D: Severe Renal Impairment Not Requiring Dialysis
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
|
|---|---|---|---|
|
Groups A, C and D; Fe: Fraction of TAK-954 Excreted in Urine
|
19.00 percentage of TAK-954 dose
Standard Deviation 5.8075
|
8.808 percentage of TAK-954 dose
Standard Deviation 4.3746
|
5.953 percentage of TAK-954 dose
Standard Deviation 4.5595
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusionPopulation: The PK set consisted of all participants who were enrolled and received at least 1 dose of trial drug and had at least 1 measurable TAK-954 plasma concentration. Here, "overall number of participants analyzed" are the participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Group A: Healthy Participants
n=5 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 milligram per kilogram \[mg/kg\], intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
|
Group C: Moderate Renal Impairment
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 mg/kg, intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
|
Group D: Severe Renal Impairment Not Requiring Dialysis
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
|
|---|---|---|---|
|
Group E; Fe: Fraction of TAK-954 Excreted in Urine in Period 1
|
0.1739 percentage of TAK-954 dose
Standard Deviation 0.10869
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusionPopulation: The PK set consisted of all participants who were enrolled and received at least 1 dose of trial drug and had at least 1 measurable TAK-954 plasma concentration. Here, "overall number of participants analyzed" are the participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Group A: Healthy Participants
n=4 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 milligram per kilogram \[mg/kg\], intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
|
Group C: Moderate Renal Impairment
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 mg/kg, intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
|
Group D: Severe Renal Impairment Not Requiring Dialysis
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
|
|---|---|---|---|
|
Group E; Fe: Fraction of TAK-954 Excreted in Urine in Period 2
|
0.6190 percentage of TAK-954 dose
Standard Deviation 0.30950
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusionPopulation: The PK set consisted of all participants who were enrolled and received at least 1 dose of study drug and had at least 1 measurable TAK-954 plasma concentration.
Outcome measures
| Measure |
Group A: Healthy Participants
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 milligram per kilogram \[mg/kg\], intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
|
Group C: Moderate Renal Impairment
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 mg/kg, intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
|
Group D: Severe Renal Impairment Not Requiring Dialysis
n=8 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
|
|---|---|---|---|
|
Groups A, C and D; CLR: Renal Clearance for TAK-954
|
2.629 liter per hour (L/h)
Standard Deviation 0.78762
|
1.255 liter per hour (L/h)
Standard Deviation 0.51478
|
0.6836 liter per hour (L/h)
Standard Deviation 0.56141
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusionPopulation: The PK set consisted of all participants who were enrolled and received at least 1 dose of trial drug and had at least 1 measurable TAK-954 plasma concentration. Here, "overall number of participants analyzed" are the participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Group A: Healthy Participants
n=5 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 milligram per kilogram \[mg/kg\], intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
|
Group C: Moderate Renal Impairment
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 mg/kg, intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
|
Group D: Severe Renal Impairment Not Requiring Dialysis
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
|
|---|---|---|---|
|
Group E; CLR: Renal Clearance for TAK-954 in Period 1
|
0.03192 L/h
Standard Deviation 0.017670
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusionPopulation: The PK set consisted of all participants who were enrolled and received at least 1 dose of trial drug and had at least 1 measurable TAK-954 plasma concentration. Here, "overall number of participants analyzed" are the participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Group A: Healthy Participants
n=4 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 milligram per kilogram \[mg/kg\], intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
|
Group C: Moderate Renal Impairment
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 mg/kg, intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
|
Group D: Severe Renal Impairment Not Requiring Dialysis
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
|
|---|---|---|---|
|
Group E; CLR: Renal Clearance for TAK-954 in Period 2
|
0.08330 L/h
Standard Deviation 0.041650
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at multiple time points (up to 4 hours) post-infusionPopulation: The PK set consisted of all participants who were enrolled and received at least 1 dose of trial drug and had at least 1 measurable TAK-954 plasma concentration.
Outcome measures
| Measure |
Group A: Healthy Participants
n=7 Participants
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 milligram per kilogram \[mg/kg\], intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
|
Group C: Moderate Renal Impairment
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 mg/kg, intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
|
Group D: Severe Renal Impairment Not Requiring Dialysis
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
|
|---|---|---|---|
|
Group E; CLD: Clearance of Dialysate for TAK-954 in Period 2
|
1.368 L/h
Geometric Coefficient of Variation 30.0
|
—
|
—
|
Adverse Events
Group A: Healthy Participants
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group C: Moderate Renal Impairment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group D: Severe Renal Impairment Not Requiring Dialysis
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group E: ESRD 1 Hour After Dialysis
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group E: ESRD 2 Hours Before Dialysis
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A: Healthy Participants
n=8 participants at risk
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different cytochrome P-450 (CYP) substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 milligram per kilogram \[mg/kg\], intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with normal renal function.
|
Group C: Moderate Renal Impairment
n=8 participants at risk
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1), followed by a minimum 13-day washout period, further followed by probe cocktail of different CYP substrates (caffeine 100 mg, oral \[CYP1A2\] + midazolam 0.025 mg/kg, intravenously \[CYP3A4\]), once on Day 1 of a 4-day period (Treatment 2) in participants with moderate renal impairment.
|
Group D: Severe Renal Impairment Not Requiring Dialysis
n=9 participants at risk
TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period (Treatment 1) in participants with severe renal impairment or ESRD without dialysis.
|
Group E: ESRD 1 Hour After Dialysis
n=7 participants at risk
TAK-954 0.2 mg, infusion, intravenously in fasted state, 1 hour after the end of dialysis, once on Day 1 of a 6-day Period 1 in participants with ESRD requiring dialysis.
|
Group E: ESRD 2 Hours Before Dialysis
n=7 participants at risk
TAK-954 0.2 mg, infusion, intravenously in fasted state, 2 hours before the start of dialysis, once on Day 1 of a 4-day Period 2 in participants with ESRD requiring dialysis.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Number of events 1 • Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug as Treatment 2 (up to Day 29) in Group A, C, and E), and Treatment 1 (up to Day 15) in for Group D
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. TEAEs includes adverse events occurred during Treatments 1 and 2 in Groups A and C, as planned.
|
12.5%
1/8 • Number of events 1 • Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug as Treatment 2 (up to Day 29) in Group A, C, and E), and Treatment 1 (up to Day 15) in for Group D
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. TEAEs includes adverse events occurred during Treatments 1 and 2 in Groups A and C, as planned.
|
22.2%
2/9 • Number of events 2 • Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug as Treatment 2 (up to Day 29) in Group A, C, and E), and Treatment 1 (up to Day 15) in for Group D
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. TEAEs includes adverse events occurred during Treatments 1 and 2 in Groups A and C, as planned.
|
14.3%
1/7 • Number of events 1 • Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug as Treatment 2 (up to Day 29) in Group A, C, and E), and Treatment 1 (up to Day 15) in for Group D
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. TEAEs includes adverse events occurred during Treatments 1 and 2 in Groups A and C, as planned.
|
28.6%
2/7 • Number of events 2 • Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug as Treatment 2 (up to Day 29) in Group A, C, and E), and Treatment 1 (up to Day 15) in for Group D
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. TEAEs includes adverse events occurred during Treatments 1 and 2 in Groups A and C, as planned.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug as Treatment 2 (up to Day 29) in Group A, C, and E), and Treatment 1 (up to Day 15) in for Group D
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. TEAEs includes adverse events occurred during Treatments 1 and 2 in Groups A and C, as planned.
|
12.5%
1/8 • Number of events 1 • Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug as Treatment 2 (up to Day 29) in Group A, C, and E), and Treatment 1 (up to Day 15) in for Group D
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. TEAEs includes adverse events occurred during Treatments 1 and 2 in Groups A and C, as planned.
|
0.00%
0/9 • Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug as Treatment 2 (up to Day 29) in Group A, C, and E), and Treatment 1 (up to Day 15) in for Group D
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. TEAEs includes adverse events occurred during Treatments 1 and 2 in Groups A and C, as planned.
|
0.00%
0/7 • Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug as Treatment 2 (up to Day 29) in Group A, C, and E), and Treatment 1 (up to Day 15) in for Group D
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. TEAEs includes adverse events occurred during Treatments 1 and 2 in Groups A and C, as planned.
|
0.00%
0/7 • Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug as Treatment 2 (up to Day 29) in Group A, C, and E), and Treatment 1 (up to Day 15) in for Group D
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. TEAEs includes adverse events occurred during Treatments 1 and 2 in Groups A and C, as planned.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug as Treatment 2 (up to Day 29) in Group A, C, and E), and Treatment 1 (up to Day 15) in for Group D
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. TEAEs includes adverse events occurred during Treatments 1 and 2 in Groups A and C, as planned.
|
12.5%
1/8 • Number of events 1 • Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug as Treatment 2 (up to Day 29) in Group A, C, and E), and Treatment 1 (up to Day 15) in for Group D
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. TEAEs includes adverse events occurred during Treatments 1 and 2 in Groups A and C, as planned.
|
0.00%
0/9 • Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug as Treatment 2 (up to Day 29) in Group A, C, and E), and Treatment 1 (up to Day 15) in for Group D
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. TEAEs includes adverse events occurred during Treatments 1 and 2 in Groups A and C, as planned.
|
0.00%
0/7 • Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug as Treatment 2 (up to Day 29) in Group A, C, and E), and Treatment 1 (up to Day 15) in for Group D
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. TEAEs includes adverse events occurred during Treatments 1 and 2 in Groups A and C, as planned.
|
0.00%
0/7 • Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug as Treatment 2 (up to Day 29) in Group A, C, and E), and Treatment 1 (up to Day 15) in for Group D
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. TEAEs includes adverse events occurred during Treatments 1 and 2 in Groups A and C, as planned.
|
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