Trial Outcomes & Findings for A Study to Determine the Bioequivalence of Alogliptin and Pioglitazone When Administered as Individual Tablets and as Fixed-Dose Combination (FDC)-SYR-322-4833 BL Tablets to Healthy Russian Participants (NCT NCT03501277)
NCT ID: NCT03501277
Last Updated: 2019-08-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Results posted on
2019-08-08
Participant Flow
Participants took part in the study at 1 investigative site in Russia from 26 May 2018 to 11 July 2018.
Healthy participants were enrolled in 1 of the 4 treatment sequences to receive: SYR-322-4833 BL (25 milligram \[mg\] + 15 mg) (Regimen A), alogliptin 25 mg + pioglitazone 15 mg (Regimen B), SYR-322-4833 (25 mg + 30 mg) (Regimen C), and alogliptin 25 mg + pioglitazone 30 mg (Regimen D).
Participant milestones
| Measure |
Sequence I: ABCD
SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) fixed dose combination (FDC) tablet, orally, once, on Day 1 of Period 1 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 2 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 3 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 4 (Regimen D).
|
Sequence II: BCDA
Alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 1 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 2 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 3 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 4 (Regimen A).
|
Sequence III: CDAB
SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 1 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 2 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 3 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 4 (Regimen B).
|
Sequence IV: DABC
Alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 1 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 2 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 3 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 4 (Regimen C).
|
|---|---|---|---|---|
|
Intervention Period 1 (4 Days)
STARTED
|
18
|
18
|
18
|
18
|
|
Intervention Period 1 (4 Days)
Safety Analysis Set
|
18
|
18
|
17
|
17
|
|
Intervention Period 1 (4 Days)
COMPLETED
|
18
|
18
|
17
|
17
|
|
Intervention Period 1 (4 Days)
NOT COMPLETED
|
0
|
0
|
1
|
1
|
|
Washout Period 1 (7 Days)
STARTED
|
18
|
18
|
17
|
17
|
|
Washout Period 1 (7 Days)
COMPLETED
|
18
|
18
|
17
|
17
|
|
Washout Period 1 (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Intervention Period 2 (4 Days)
STARTED
|
18
|
18
|
17
|
17
|
|
Intervention Period 2 (4 Days)
COMPLETED
|
18
|
18
|
17
|
16
|
|
Intervention Period 2 (4 Days)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Washout Period 2 (7 Days)
STARTED
|
18
|
18
|
17
|
16
|
|
Washout Period 2 (7 Days)
COMPLETED
|
18
|
18
|
17
|
16
|
|
Washout Period 2 (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Intervention Period 3 (4 Days)
STARTED
|
18
|
18
|
17
|
16
|
|
Intervention Period 3 (4 Days)
COMPLETED
|
18
|
18
|
17
|
15
|
|
Intervention Period 3 (4 Days)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Washout Period 3 (7 Days)
STARTED
|
18
|
18
|
17
|
15
|
|
Washout Period 3 (7 Days)
COMPLETED
|
18
|
18
|
17
|
15
|
|
Washout Period 3 (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Intervention Period 4 (4 Days)
STARTED
|
18
|
18
|
17
|
15
|
|
Intervention Period 4 (4 Days)
COMPLETED
|
18
|
18
|
17
|
15
|
|
Intervention Period 4 (4 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence I: ABCD
SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) fixed dose combination (FDC) tablet, orally, once, on Day 1 of Period 1 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 2 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 3 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 4 (Regimen D).
|
Sequence II: BCDA
Alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 1 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 2 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 3 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 4 (Regimen A).
|
Sequence III: CDAB
SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 1 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 2 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 3 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 4 (Regimen B).
|
Sequence IV: DABC
Alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 1 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 2 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 3 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 4 (Regimen C).
|
|---|---|---|---|---|
|
Intervention Period 1 (4 Days)
Other
|
0
|
0
|
1
|
0
|
|
Intervention Period 1 (4 Days)
Adverse Event
|
0
|
0
|
0
|
1
|
|
Intervention Period 2 (4 Days)
Adverse Event
|
0
|
0
|
0
|
1
|
|
Intervention Period 3 (4 Days)
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Determine the Bioequivalence of Alogliptin and Pioglitazone When Administered as Individual Tablets and as Fixed-Dose Combination (FDC)-SYR-322-4833 BL Tablets to Healthy Russian Participants
Baseline characteristics by cohort
| Measure |
Sequence I: ABCD
n=18 Participants
SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) fixed dose combination (FDC) tablet, orally, once, on Day 1 of Period 1 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 2 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 3 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 4 (Regimen D).
|
Sequence II: BCDA
n=18 Participants
Alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 1 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 2 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 3 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 4 (Regimen A).
|
Sequence III: CDAB
n=17 Participants
SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 1 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 2 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 3 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 4 (Regimen B).
|
Sequence IV: DABC
n=17 Participants
Alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 1 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 2 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 3 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 4 (Regimen C).
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
28.9 years
STANDARD_DEVIATION 7.95 • n=5 Participants
|
23.9 years
STANDARD_DEVIATION 4.60 • n=7 Participants
|
29.4 years
STANDARD_DEVIATION 8.46 • n=5 Participants
|
27.5 years
STANDARD_DEVIATION 6.36 • n=4 Participants
|
27.4 years
STANDARD_DEVIATION 7.18 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
37 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
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
70 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
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
70 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
Russia
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Weight
|
68.77 kilogram (kg)
STANDARD_DEVIATION 12.527 • n=5 Participants
|
69.86 kilogram (kg)
STANDARD_DEVIATION 12.409 • n=7 Participants
|
75.06 kilogram (kg)
STANDARD_DEVIATION 14.643 • n=5 Participants
|
71.22 kilogram (kg)
STANDARD_DEVIATION 15.894 • n=4 Participants
|
71.17 kilogram (kg)
STANDARD_DEVIATION 13.806 • n=21 Participants
|
|
Body mass index (BMI)
|
24.21 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.411 • n=5 Participants
|
24.06 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.959 • n=7 Participants
|
24.78 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.575 • n=5 Participants
|
24.89 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.628 • n=4 Participants
|
24.48 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.342 • n=21 Participants
|
|
Height
|
168.3 centimeter (cm)
STANDARD_DEVIATION 8.56 • n=5 Participants
|
169.9 centimeter (cm)
STANDARD_DEVIATION 8.02 • n=7 Participants
|
173.6 centimeter (cm)
STANDARD_DEVIATION 10.22 • n=5 Participants
|
168.4 centimeter (cm)
STANDARD_DEVIATION 9.44 • n=4 Participants
|
170.0 centimeter (cm)
STANDARD_DEVIATION 9.14 • n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The pharmacokinetic (PK) analysis set included all participants in the safety set who had sufficient plasma concentration data to facilitate the derivation of at least 1 PK parameter.
Outcome measures
| Measure |
Regimen A
n=70 Participants
SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
|
Regimen B
n=69 Participants
Alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
|
Regimen C
n=68 Participants
SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
|
Regimen D
n=70 Participants
Alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
|
|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Alogliptin and Pioglitazone
Alogliptin
|
165.3 nanogram per milliliter (ng/ml)
Standard Deviation 42.87
|
154.9 nanogram per milliliter (ng/ml)
Standard Deviation 44.71
|
162.3 nanogram per milliliter (ng/ml)
Standard Deviation 51.19
|
157.4 nanogram per milliliter (ng/ml)
Standard Deviation 44.24
|
|
Cmax: Maximum Observed Plasma Concentration for Alogliptin and Pioglitazone
Pioglitazone
|
678.3 nanogram per milliliter (ng/ml)
Standard Deviation 267.58
|
706.5 nanogram per milliliter (ng/ml)
Standard Deviation 254.12
|
1052.1 nanogram per milliliter (ng/ml)
Standard Deviation 478.13
|
1141.5 nanogram per milliliter (ng/ml)
Standard Deviation 509.78
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The PK analysis set included all participants in the safety set who had sufficient plasma concentration data to facilitate the derivation of at least 1 PK parameter.
Outcome measures
| Measure |
Regimen A
n=70 Participants
SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
|
Regimen B
n=69 Participants
Alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
|
Regimen C
n=68 Participants
SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
|
Regimen D
n=70 Participants
Alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
|
|---|---|---|---|---|
|
AUC(0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Alogliptin and Pioglitazone
Alogliptin
|
2197.3 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 340.92
|
2163.4 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 362.83
|
2194.7 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 379.27
|
2195.0 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 379.80
|
|
AUC(0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Alogliptin and Pioglitazone
Pioglitazone
|
5726.0 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 1826.18
|
5471.9 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 1766.76
|
10141.6 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 3611.38
|
9907.6 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 3495.57
|
Adverse Events
Regimen A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Regimen B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Regimen C
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Regimen D
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 |
Regimen A
n=70 participants at risk
SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
|
Regimen B
n=69 participants at risk
Alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
|
Regimen C
n=68 participants at risk
SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
|
Regimen D
n=70 participants at risk
Alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 1, 2, 3 or 4.
|
|---|---|---|---|---|
|
Immune system disorders
Allergic oedema
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
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.
|
1.4%
1/69 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/68 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/68 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/68 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/68 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
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.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/68 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
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.
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
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.
|
1.5%
1/68 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Syncope
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/68 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypotension
|
1.4%
1/70 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/68 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/70 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER