A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the effect of varying degrees of renal function on the PK of TAK-954 following single-dose IV administration and to investigate the impact of hemodialysis on the PK of single IV doses of TAK-954.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Detailed Description
The drug being tested in this study is called TAK-954. This study will evaluate the effect of varying degrees of renal function on the PK of TAK-954 following single-dose IV administration and to investigate the impact of hemodialysis on the PK of single IV doses of TAK-954.
The study will enroll approximately up to 40 participants. Participants will be enrolled in one of the 5 treatment groups based on their renal impairment which will be determined based on Cockcroft and Gault (CG) equation as follows:
-
Group A TAK-954 0.2 mg: Healthy Participants
-
Group B TAK-954 0.2 mg: Mild Renal Impairment
-
Group C TAK-954 0.2 mg: Moderate Renal Impairment
-
Group D TAK-954 0.2 mg: Severe Renal Impairment or End-stage Renal Disease (ESRD) Without Hemodialysis
-
Group E TAK-954 0.2 mg: End-stage Renal Disease (ESRD) With Hemodialysis
All participants in groups A to D will receive a single dose of TAK-954 and two single doses in Group E.
Enrollment in Group B (Mild) and Group E (ESRD requiring dialysis) will be based on assessment of safety and available PK data from Group C and Group D respectively.
This multi-center trial will be conducted in Czech Republic and Hungary. The overall time to participate in this study is approximately 8 weeks. Participants in Groups A to D will remain confined to clinic for 3 days. For both treatments, participants in Group E requiring dialysis will remain confined to clinic for 3 days. All participants will make a final visit to the clinic 10-14 days after receiving their last dose for a follow-up assessment.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Group A TAK-954 0.2 mg: Healthy Participants Participants with normal renal function receive TAK-954 0.2 milligram (mg), infusion, intravenously in fasted state, once on Day 1 of a 6-day period. |
Drug: TAK-954
TAK-954 intravenous infusion.
|
Experimental: Group B TAK-954 0.2 mg: Mild Renal Impairment Participants receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period. |
Drug: TAK-954
TAK-954 intravenous infusion.
|
Experimental: Group C TAK-954 0.2 mg: Moderate Renal Impairment Participants receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period. |
Drug: TAK-954
TAK-954 intravenous infusion.
|
Experimental: Group D TAK-954 0.2 mg: Severe Renal Impairment Participants without hemodialysis or End-stage Renal Disease (ESRD) receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period. |
Drug: TAK-954
TAK-954 intravenous infusion.
|
Experimental: Group E TAK-954 0.2 mg: End-stage Renal Disease (ESRD) Participants with hemodialysis receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 4-day period followed by a minimum 13-day washout period, further followed by TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 4-day period. |
Drug: TAK-954
TAK-954 intravenous infusion.
|
Outcome Measures
Primary Outcome Measures
- Groups A, C and D; Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free) [Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion]
- 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) [Day 1 pre-infusion and at multiple time points (up to 72 hours) post-infusion]
- 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) [Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion]
- Groups A, C and D; AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 (Free and Total) [Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion]
- Groups A, C and D; Ae: Amount of TAK-954 Excreted in Urine [Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion]
- Group E; Ae: Amount of TAK-954 Excreted in Urine in Period 1 [Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion]
- Group E; Ae: Amount of TAK-954 Excreted in Urine in Period 2 [Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion]
- Groups A, C and D; Fe: Fraction of TAK-954 Excreted in Urine [Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion]
- Group E; Fe: Fraction of TAK-954 Excreted in Urine in Period 1 [Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion]
- Group E; Fe: Fraction of TAK-954 Excreted in Urine in Period 2 [Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion]
- Groups A, C and D; CLR: Renal Clearance for TAK-954 [Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion]
- Group E; CLR: Renal Clearance for TAK-954 in Period 1 [Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion]
- Group E; CLR: Renal Clearance for TAK-954 in Period 2 [Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion]
- Group E; CLD: Clearance of Dialysate for TAK-954 in Period 2 [Day 1 pre-infusion and at multiple time points (up to 4 hours) post-infusion]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
All participants: Male and female participants (non-childbearing potential) who are aged 18 to 75 years, inclusive, with a body mass index (BMI) between 18 to 35 kilogram per square meter (kg/m^2).
-
Group A: As much as possible, the healthy participants with normal renal function (creatinine clearance [CLcr] greater than or equal to [>=] 90 milliliter per minute [mL/min]) should be comparable to participants with renal impairment with respect to median age and weight (approximately 50 percent [%] of healthy participants on each side of the median age and weight of currently enrolled renally-impaired participants grouped together), sex, and race. This will be decided by the investigators in discussion with Takeda.
-
Groups B to E: Participants who have stable RI, defined as no clinically significant change in disease status, as documented by the participant's most recent CLcr assessment; serum creatinine must not vary more than approximately 30% from Screening to Day -1 to confirm stable disease. Participants should also be in good health commensurate with their renal status.
-
Group B: Participants with mild RI (CLcr 60 to less than [<] 90 mL/min).
-
Group C: Participants with moderate RI (CLcr 30 to <60 mL/min).
-
Group D: Participants with severe RI or ESRD but not requiring dialysis (CLcr <30 mL/min).
-
Group E: Participants with ESRD requiring dialysis (<15 mL/min requiring hemodialysis at least 3 times/week, and having been on the same dialysis treatment regimen for at least 1 month before trial entry).
- Participants should be on a stable drug regimen defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) before dosing with TAK-954.
Exclusion Criteria:
- All participants:
-
Are renal allograft recipients within 1 year of screening.
-
Have a history of gastrointestinal (GI) motility disorder or intestinal obstruction.
-
Have urinary incontinence without catheterization.
-
Group A: Participants who, in the discretion of the investigator, have a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases will be excluded from the trial.
-
Groups B to E:
-
Receive dialysis other than intermittent dialysis (except Group E).
-
Have renal disease secondary to hepatic disease (hepatorenal syndrome).
-
At the discretion of the investigators, have any significant hepatic, cardiac, or pulmonary disease or participants who are clinically nephrotic.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | PRA CZ, s.r.o | Praha 7 | Praha | Czechia | 170 00 |
2 | Fakultni Nemocnice Hradec Kralove | Hradec Kralove | Czechia | 500 05 | |
3 | PRA Magyarorszag Kft. | Budapest | Hungary | 1077 | |
4 | Szent Imre Egyetemi Oktatokorhaz Belgyogyazati Szakmak Matrix Intezet | Budapest | Hungary | 1115 |
Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Medical Director, Takeda
Study Documents (Full-Text)
More Information
Publications
None provided.- TAK-954-1007
- U1111-1196-9206
- 2017-000715-16
Study Results
Participant Flow
Recruitment Details | Participants took part in the study at 4 investigative sites in Czech Republic and Hungary from 21 November 2017 to 09 August 2019. |
---|---|
Pre-assignment Detail | 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). |
Arm/Group Title | Group A: Healthy Participants | Group C: Moderate Renal Impairment | Group D: Severe Renal Impairment Not Requiring Dialysis | Group E: ESRD Requiring Dialysis |
---|---|---|---|---|
Arm/Group Description | 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. | 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. | 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. | 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. |
Period Title: Overall Study | ||||
STARTED | 8 | 8 | 9 | 7 |
COMPLETED | 8 | 8 | 9 | 7 |
NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Group A: Healthy Participants | Group C: Moderate Renal Impairment | Group D: Severe Renal Impairment Not Requiring Dialysis | Group E: ESRD Requiring Dialysis | Total |
---|---|---|---|---|---|
Arm/Group Description | 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. | 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. | 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. | 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 of all reporting groups |
Overall Participants | 8 | 8 | 9 | 7 | 32 |
Age (years) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [years] |
57.0
(15.62)
|
70.6
(3.50)
|
62.2
(11.03)
|
52.6
(10.06)
|
60.9
(12.38)
|
Sex: Female, Male (Count of Participants) | |||||
Female |
3
37.5%
|
4
50%
|
4
44.4%
|
0
0%
|
11
34.4%
|
Male |
5
62.5%
|
4
50%
|
5
55.6%
|
7
100%
|
21
65.6%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||||
Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Not Hispanic or Latino |
8
100%
|
8
100%
|
9
100%
|
7
100%
|
32
100%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
White |
8
100%
|
8
100%
|
9
100%
|
7
100%
|
32
100%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (Count of Participants) | |||||
Czech Republic |
6
75%
|
6
75%
|
5
55.6%
|
3
42.9%
|
20
62.5%
|
Hungary |
2
25%
|
2
25%
|
4
44.4%
|
4
57.1%
|
12
37.5%
|
Weight (kilogram (kg)) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [kilogram (kg)] |
79.95
(7.773)
|
75.95
(13.035)
|
76.22
(14.457)
|
82.39
(7.006)
|
78.43
(11.072)
|
Body Mass Index (BMI) (kilogram per square meter (kg/m^2)) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [kilogram per square meter (kg/m^2)] |
26.88
(4.051)
|
26.25
(4.166)
|
27.33
(4.272)
|
28.14
(2.673)
|
27.13
(3.765)
|
Height (centimeter (cm)) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [centimeter (cm)] |
173.25
(9.706)
|
170.25
(9.543)
|
166.89
(9.519)
|
171.00
(6.976)
|
170.22
(8.965)
|
Creatine Clearance (milliliter per minute (mL/min)) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [milliliter per minute (mL/min)] |
107.11
(23.417)
|
46.20
(10.767)
|
23.20
(6.385)
|
10.54
(2.504)
|
47.16
(39.484)
|
Estimated Glomerular Filtration Rate (eGFR) (milliliter per minute/1.73 square meter) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [milliliter per minute/1.73 square meter] |
89.93
(13.779)
|
41.68
(11.527)
|
18.13
(8.648)
|
6.93
(2.757)
|
39.52
(33.514)
|
Outcome Measures
Title | Groups A, C and D; Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free) |
---|---|
Description | |
Time Frame | Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Group A: Healthy Participants | Group C: Moderate Renal Impairment | Group D: Severe Renal Impairment Not Requiring Dialysis |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 8 | 8 | 8 |
TAK-954 (Total) |
2.623
(12.8)
|
2.536
(23.2)
|
2.660
(17.6)
|
TAK-954 (Free) |
0.1270
(29.2)
|
0.1282
(22.5)
|
0.1572
(21.7)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Group A: Healthy Participants, Group C: Moderate Renal Impairment |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | TAK-954 (Total): An analysis of variance (ANOVA) were performed on log transformed Cmax (total TAK-954) to compare moderate renal impairment group with the normal renal function group. | |
Statistical Test of Hypothesis | p-Value | 0.7265 |
Comments | ||
Method | ANOVA | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Group A: Healthy Participants, Group D: Severe Renal Impairment Not Requiring Dialysis |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | TAK-954 (Total): An ANOVA were performed on log transformed Cmax (total TAK-954) to compare severe renal impairment group with the normal renal function group. | |
Statistical Test of Hypothesis | p-Value | 0.9839 |
Comments | ||
Method | ANOVA | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Group A: Healthy Participants, Group C: Moderate Renal Impairment |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | TAK-954 (Free): An ANOVA were performed on natural logarithm of Cmax (free TAK-954) to compare moderate renal impairment group with the normal renal function group. | |
Statistical Test of Hypothesis | p-Value | 0.9393 |
Comments | ||
Method | ANOVA | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Group A: Healthy Participants, Group D: Severe Renal Impairment Not Requiring Dialysis |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | TAK-954 (Free): An ANOVA were performed on natural logarithm of Cmax (free TAK-954) to compare severe renal impairment group with the normal renal function group. | |
Statistical Test of Hypothesis | p-Value | 0.1321 |
Comments | ||
Method | ANOVA | |
Comments |
Title | 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) |
---|---|
Description | |
Time Frame | Day 1 pre-infusion and at multiple time points (up to 72 hours) post-infusion |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Group A: Healthy Participants | Group C: Moderate Renal Impairment | Group D: Severe Renal Impairment Not Requiring Dialysis |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 8 | 8 | 8 |
TAK-954 (Total) |
22.25
(19.1)
|
24.91
(22.9)
|
28.62
(18.1)
|
TAK-954 (Free) |
1.078
(25.7)
|
1.259
(25.1)
|
1.690
(25.9)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Group A: Healthy Participants, Group C: Moderate Renal Impairment |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | TAK-954 (Total): An ANOVA were performed on log transformed AUC(0-72) (total TAK-954) to compare moderate renal impairment group with the normal renal function group. | |
Statistical Test of Hypothesis | p-Value | 0.3600 |
Comments | ||
Method | ANOVA | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Group A: Healthy Participants, Group D: Severe Renal Impairment Not Requiring Dialysis |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | TAK-954 (Total): An ANOVA were performed on log transformed AUC(0-72) (total TAK-954) to compare severe renal impairment group with the normal renal function group. | |
Statistical Test of Hypothesis | p-Value | 0.0816 |
Comments | ||
Method | ANOVA | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Group A: Healthy Participants, Group C: Moderate Renal Impairment |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC(0-72) (free TAK-954) to compare moderate renal impairment group with the normal renal function group. | |
Statistical Test of Hypothesis | p-Value | 0.2686 |
Comments | ||
Method | ANOVA | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Group A: Healthy Participants, Group D: Severe Renal Impairment Not Requiring Dialysis |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC(0-72) (free TAK-954) to compare severe renal impairment group with the normal renal function group. | |
Statistical Test of Hypothesis | p-Value | 0.0059 |
Comments | ||
Method | ANOVA | |
Comments |
Title | 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) |
---|---|
Description | |
Time Frame | Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Group A: Healthy Participants | Group C: Moderate Renal Impairment | Group D: Severe Renal Impairment Not Requiring Dialysis |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 8 | 8 | 8 |
TAK-954 (Total) |
24.39
(17.7)
|
30.00
(20.0)
|
34.28
(19.3)
|
TAK-954 (Free) |
1.184
(26.8)
|
1.516
(24.3)
|
2.025
(26.7)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Group A: Healthy Participants, Group C: Moderate Renal Impairment |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | TAK-954 (Total): An ANOVA were performed on log transformed AUClast (total TAK-954) to compare moderate renal impairment group with the normal renal function group. | |
Statistical Test of Hypothesis | p-Value | 0.0998 |
Comments | ||
Method | ANOVA | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Group A: Healthy Participants, Group D: Severe Renal Impairment Not Requiring Dialysis |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | TAK-954 (Total): An ANOVA were performed on log transformed AUClast (total TAK-954) to compare severe renal impairment group with the normal renal function group. | |
Statistical Test of Hypothesis | p-Value | 0.0155 |
Comments | ||
Method | ANOVA | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Group A: Healthy Participants, Group C: Moderate Renal Impairment |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | TAK-954 (Free): An ANOVA were performed on natural logarithm of AUClast (free TAK-954) to compare moderate renal impairment group with the normal renal function group. | |
Statistical Test of Hypothesis | p-Value | 0.0916 |
Comments | ||
Method | ANOVA | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Group A: Healthy Participants, Group D: Severe Renal Impairment Not Requiring Dialysis |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | TAK-954 (Free): An ANOVA were performed on natural logarithm of AUClast (free TAK-954) to compare severe renal impairment group with the normal renal function group. | |
Statistical Test of Hypothesis | p-Value | 0.0014 |
Comments | ||
Method | ANOVA | |
Comments |
Title | Groups A, C and D; AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 (Free and Total) |
---|---|
Description | |
Time Frame | Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Group A: Healthy Participants | Group C: Moderate Renal Impairment | Group D: Severe Renal Impairment Not Requiring Dialysis |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 8 | 7 | 7 |
TAK-954 (Total) |
25.43
(16.8)
|
34.90
(16.2)
|
38.59
(23.9)
|
TAK-954 (Free) |
1.234
(28.4)
|
1.749
(24.8)
|
2.320
(29.7)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Group A: Healthy Participants, Group C: Moderate Renal Impairment |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | TAK-954 (Total): An ANOVA were performed on log transformed AUC∞ (total TAK-954) to compare moderate renal impairment group with the normal renal function group. | |
Statistical Test of Hypothesis | p-Value | 0.0038 |
Comments | ||
Method | ANOVA | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Group A: Healthy Participants, Group D: Severe Renal Impairment Not Requiring Dialysis |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | TAK-954 (Total): An ANOVA were performed on log transformed AUC∞ (total TAK-954) to compare severe renal impairment group with the normal renal function group. | |
Statistical Test of Hypothesis | p-Value | 0.0004 |
Comments | ||
Method | ANOVA | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Group A: Healthy Participants, Group C: Moderate Renal Impairment |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC∞ (free TAK-954) to compare moderate renal impairment group with the normal renal function group. | |
Statistical Test of Hypothesis | p-Value | 0.0389 |
Comments | ||
Method | ANOVA | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Group A: Healthy Participants, Group D: Severe Renal Impairment Not Requiring Dialysis |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC∞ (free TAK-954) to compare severe renal impairment group with the normal renal function group. | |
Statistical Test of Hypothesis | p-Value | 0.0011 |
Comments | ||
Method | ANOVA | |
Comments |
Title | Groups A, C and D; Ae: Amount of TAK-954 Excreted in Urine |
---|---|
Description | |
Time Frame | Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Group A: Healthy Participants | Group C: Moderate Renal Impairment | Group D: Severe Renal Impairment Not Requiring Dialysis |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 8 | 8 | 8 |
Geometric Mean (Standard Deviation) [milligram (mg)] |
0.03797
(0.011633)
|
0.01763
(0.0087713)
|
0.01190
(0.0091124)
|
Title | Group E; Ae: Amount of TAK-954 Excreted in Urine in Period 1 |
---|---|
Description | |
Time Frame | Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Group E: ESRD Requiring Dialysis |
---|---|
Arm/Group Description | 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. |
Measure Participants | 5 |
Geometric Mean (Standard Deviation) [mg] |
0.0003489
(0.00021788)
|
Title | Group E; Ae: Amount of TAK-954 Excreted in Urine in Period 2 |
---|---|
Description | |
Time Frame | Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Group E: ESRD Requiring Dialysis |
---|---|
Arm/Group Description | 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. |
Measure Participants | 4 |
Geometric Mean (Standard Deviation) [mg] |
0.001240
(0.00062000)
|
Title | Groups A, C and D; Fe: Fraction of TAK-954 Excreted in Urine |
---|---|
Description | |
Time Frame | Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Group A: Healthy Participants | Group C: Moderate Renal Impairment | Group D: Severe Renal Impairment Not Requiring Dialysis |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 8 | 8 | 8 |
Geometric Mean (Standard Deviation) [percentage of TAK-954 dose] |
19.00
(5.8075)
|
8.808
(4.3746)
|
5.953
(4.5595)
|
Title | Group E; Fe: Fraction of TAK-954 Excreted in Urine in Period 1 |
---|---|
Description | |
Time Frame | Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Group E: ESRD Requiring Dialysis |
---|---|
Arm/Group Description | 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. |
Measure Participants | 5 |
Geometric Mean (Standard Deviation) [percentage of TAK-954 dose] |
0.1739
(0.10869)
|
Title | Group E; Fe: Fraction of TAK-954 Excreted in Urine in Period 2 |
---|---|
Description | |
Time Frame | Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Group E: ESRD Requiring Dialysis |
---|---|
Arm/Group Description | 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. |
Measure Participants | 4 |
Geometric Mean (Standard Deviation) [percentage of TAK-954 dose] |
0.6190
(0.30950)
|
Title | Groups A, C and D; CLR: Renal Clearance for TAK-954 |
---|---|
Description | |
Time Frame | Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Group A: Healthy Participants | Group C: Moderate Renal Impairment | Group D: Severe Renal Impairment Not Requiring Dialysis |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Measure Participants | 8 | 8 | 8 |
Geometric Mean (Standard Deviation) [liter per hour (L/h)] |
2.629
(0.78762)
|
1.255
(0.51478)
|
0.6836
(0.56141)
|
Title | Group E; CLR: Renal Clearance for TAK-954 in Period 1 |
---|---|
Description | |
Time Frame | Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Group E: ESRD Requiring Dialysis |
---|---|
Arm/Group Description | 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. |
Measure Participants | 5 |
Geometric Mean (Standard Deviation) [L/h] |
0.03192
(0.017670)
|
Title | Group E; CLR: Renal Clearance for TAK-954 in Period 2 |
---|---|
Description | |
Time Frame | Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Group E: ESRD Requiring Dialysis |
---|---|
Arm/Group Description | 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. |
Measure Participants | 4 |
Geometric Mean (Standard Deviation) [L/h] |
0.08330
(0.041650)
|
Title | Group E; CLD: Clearance of Dialysate for TAK-954 in Period 2 |
---|---|
Description | |
Time Frame | Day 1 pre-infusion and at multiple time points (up to 4 hours) post-infusion |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Group E: ESRD Requiring Dialysis |
---|---|
Arm/Group Description | 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. |
Measure Participants | 7 |
Geometric Mean (Geometric Coefficient of Variation) [L/h] |
1.368
(30.0)
|
Adverse Events
Time Frame | 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 | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | 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. | |||||||||
Arm/Group Title | Group A: Healthy Participants | Group C: Moderate Renal Impairment | Group D: Severe Renal Impairment Not Requiring Dialysis | Group E: ESRD 1 Hour After Dialysis | Group E: ESRD 2 Hours Before Dialysis | |||||
Arm/Group Description | 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. | 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. | 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. | 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. | 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. | |||||
All Cause Mortality |
||||||||||
Group A: Healthy Participants | Group C: Moderate Renal Impairment | Group D: Severe Renal Impairment Not Requiring Dialysis | Group E: ESRD 1 Hour After Dialysis | Group E: ESRD 2 Hours Before Dialysis | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | |||||
Serious Adverse Events |
||||||||||
Group A: Healthy Participants | Group C: Moderate Renal Impairment | Group D: Severe Renal Impairment Not Requiring Dialysis | Group E: ESRD 1 Hour After Dialysis | Group E: ESRD 2 Hours Before Dialysis | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | 0/7 (0%) | 0/7 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
Group A: Healthy Participants | Group C: Moderate Renal Impairment | Group D: Severe Renal Impairment Not Requiring Dialysis | Group E: ESRD 1 Hour After Dialysis | Group E: ESRD 2 Hours Before Dialysis | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/8 (12.5%) | 2/8 (25%) | 2/9 (22.2%) | 1/7 (14.3%) | 2/7 (28.6%) | |||||
Gastrointestinal disorders | ||||||||||
Diarrhoea | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 2/9 (22.2%) | 2 | 1/7 (14.3%) | 1 | 2/7 (28.6%) | 2 |
Nervous system disorders | ||||||||||
Headache | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 | 0/7 (0%) | 0 | 0/7 (0%) | 0 |
Depressed level of consciousness | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 | 0/7 (0%) | 0 | 0/7 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Medical Director |
---|---|
Organization | Takeda |
Phone | +1-877-825-3327 |
trialdisclosures@takeda.com |
- TAK-954-1007
- U1111-1196-9206
- 2017-000715-16