Trial Outcomes & Findings for Pharmacokinetics and Pharmacodynamics Study of Alogliptin in Healthy Korean Participants (NCT NCT01391663)
NCT ID: NCT01391663
Last Updated: 2013-03-22
Results Overview
Maximum observed plasma concentration (Cmax) is the peak plasma concentration after administrations of a single dose and multiple doses of the study drug
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Day 1-4, Day 10
Results posted on
2013-03-22
Participant Flow
Participants took part in the study at a single investigative site in South Korea from 25 July 2011 to 02 September 2011.
Healthy Korean participants were enrolled in either alogliptin 12.5 mg, 25 mg or 50 mg once-daily (QD) treatment groups.
Participant milestones
| Measure |
Alogliptin 12.5 mg QD
Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 25 mg QD
Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 50 mg QD
Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
|
Placebo
Placebo tablets, orally, two tablets taken once daily for up to 7 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Alogliptin 12.5 mg QD
Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 25 mg QD
Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 50 mg QD
Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
|
Placebo
Placebo tablets, orally, two tablets taken once daily for up to 7 days.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Pharmacokinetics and Pharmacodynamics Study of Alogliptin in Healthy Korean Participants
Baseline characteristics by cohort
| Measure |
Alogliptin 12.5 mg QD
n=12 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 25 mg QD
n=12 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 50 mg QD
n=12 Participants
Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
|
Placebo
n=12 Participants
Placebo tablets, orally, two tablets taken once daily for up to 7 days.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
26.6 Years
STANDARD_DEVIATION 5.05 • n=5 Participants
|
23.5 Years
STANDARD_DEVIATION 2.75 • n=7 Participants
|
25.3 Years
STANDARD_DEVIATION 7.88 • n=5 Participants
|
25.8 Years
STANDARD_DEVIATION 2.17 • n=4 Participants
|
25.3 Years
STANDARD_DEVIATION 4.97 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Korean
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
48 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
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
|
|
Height
|
171.7 cm
STANDARD_DEVIATION 9.05 • n=5 Participants
|
170.3 cm
STANDARD_DEVIATION 8.52 • n=7 Participants
|
171.2 cm
STANDARD_DEVIATION 8.62 • n=5 Participants
|
168.9 cm
STANDARD_DEVIATION 8.11 • n=4 Participants
|
170.5 cm
STANDARD_DEVIATION 8.37 • n=21 Participants
|
|
Weight
|
65.33 kg
STANDARD_DEVIATION 8.76 • n=5 Participants
|
63.37 kg
STANDARD_DEVIATION 10.49 • n=7 Participants
|
62.84 kg
STANDARD_DEVIATION 9.78 • n=5 Participants
|
60.85 kg
STANDARD_DEVIATION 8.891 • n=4 Participants
|
63.10 kg
STANDARD_DEVIATION 9.34 • n=21 Participants
|
|
Body Mass Index (BMI)
|
22.17 kg/m2
STANDARD_DEVIATION 1.35 • n=5 Participants
|
21.67 kg/m2
STANDARD_DEVIATION 2.31 • n=7 Participants
|
21.53 kg/m2
STANDARD_DEVIATION 2.41 • n=5 Participants
|
21.00 kg/m2
STANDARD_DEVIATION 1.525 • n=4 Participants
|
21.59 kg/m2
STANDARD_DEVIATION 1.94 • n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1-4, Day 10Population: Healthy Korean Participants
Maximum observed plasma concentration (Cmax) is the peak plasma concentration after administrations of a single dose and multiple doses of the study drug
Outcome measures
| Measure |
Alogliptin 12.5 mg QD
n=12 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 25 mg QD
n=12 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 50 mg QD
n=12 Participants
Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
|
Placebo
n=12 Participants
Placebo tablets, orally, two tablets taken once daily for up to 7 days.
|
|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter
Day 1 (n=12; n=12; n=12; n=12)
|
55.28 ng/mL
Standard Deviation 10.700
|
114.08 ng/mL
Standard Deviation 36.611
|
246.00 ng/mL
Standard Deviation 89.699
|
NA ng/mL
Standard Deviation NA
No values were collected for placebo Arm
|
|
Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter
Day 10 (n=12; n=12; n=11; n=12)
|
75.38 ng/mL
Standard Deviation 14.708
|
154.83 ng/mL
Standard Deviation 34.842
|
335.36 ng/mL
Standard Deviation 61.983
|
NA ng/mL
Standard Deviation NA
No values were collected for placebo Arm
|
PRIMARY outcome
Timeframe: Day 1-4, Day 10.Population: Healthy Korean Participants
Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug
Outcome measures
| Measure |
Alogliptin 12.5 mg QD
n=12 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 25 mg QD
n=12 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 50 mg QD
n=12 Participants
Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
|
Placebo
n=12 Participants
Placebo tablets, orally, two tablets taken once daily for up to 7 days.
|
|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter
Day 1 (n=12; n=12; n=12; n=12)
|
1.49 hr
Interval 1.0 to 6.0
|
1.01 hr
Interval 0.52 to 3.033
|
3.00 hr
Interval 0.52 to 6.08
|
NA hr
No values were collected for placebo Arm
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter
Day 10 (n=12; n=12; n=11; n=12)
|
1.02 hr
Interval 0.97 to 6.0
|
2.00 hr
Interval 0.98 to 6.0
|
1.02 hr
Interval 0.48 to 4.0
|
NA hr
No values were collected for placebo Arm
|
PRIMARY outcome
Timeframe: Day 1-4Population: Healthy Korean Participants
Area under the plasma concentration-time curve from time 0 to infinity after administration of a single dose of the study drug.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD
n=12 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 25 mg QD
n=12 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 50 mg QD
n=12 Participants
Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
|
Placebo
n=12 Participants
Placebo tablets, orally, two tablets taken once daily for up to 7 days.
|
|---|---|---|---|---|
|
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter
|
895.28 ng·hr/mL
Standard Deviation 78.639
|
1674.88 ng·hr/mL
Standard Deviation 308.115
|
3306.68 ng·hr/mL
Standard Deviation 530.295
|
NA ng·hr/mL
Standard Deviation NA
No values were collected for placebo Arm
|
PRIMARY outcome
Timeframe: Day 1-4, Day 10.Population: Healthy Korean Participants
Area under the curve from 0 to 24 hours after administrations of a single dose and multiple doses of the study drug.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD
n=12 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 25 mg QD
n=12 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 50 mg QD
n=12 Participants
Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
|
Placebo
n=12 Participants
Placebo tablets, orally, two tablets taken once daily for up to 7 days.
|
|---|---|---|---|---|
|
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter.
Day 1 (n=12; n=12; n=12; n=12)
|
601.65 ng·hr/mL
Standard Deviation 77.520
|
1174.76 ng·hr/mL
Standard Deviation 184.062
|
2488.48 ng·hr/mL
Standard Deviation 408.016
|
NA ng·hr/mL
Standard Deviation NA
No values were collected for placebo Arm
|
|
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter.
Day 10 (n=12; n=12; n=11; n=12)
|
842.17 ng·hr/mL
Standard Deviation 84.110
|
1625.58 ng·hr/mL
Standard Deviation 397.301
|
3389.21 ng·hr/mL
Standard Deviation 406.082
|
NA ng·hr/mL
Standard Deviation NA
No values were collected for placebo Arm
|
PRIMARY outcome
Timeframe: Day 1-4Population: Healthy Korean Participants
Time required for half of the drug to be eliminated from the plasma after administration of a single dose of the study drug.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD
n=12 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 25 mg QD
n=12 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 50 mg QD
n=12 Participants
Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
|
Placebo
n=12 Participants
Placebo tablets, orally, two tablets taken once daily for up to 7 days.
|
|---|---|---|---|---|
|
Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter
|
20.67 hr
Standard Deviation 2.067
|
19.45 hr
Standard Deviation 3.433
|
17.00 hr
Standard Deviation 3.104
|
NA hr
Standard Deviation NA
No values were collected for placebo Arm
|
PRIMARY outcome
Timeframe: Day 1-4Population: Healthy Korean Participants
CL/F is apparent clearance of the drug from the plasma after administration of a single dose of the study drug.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD
n=12 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 25 mg QD
n=12 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 50 mg QD
n=12 Participants
Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
|
Placebo
n=12 Participants
Placebo tablets, orally, two tablets taken once daily for up to 7 days.
|
|---|---|---|---|---|
|
Oral Clearance (CL/F) Pharmacokinetic Parameter
|
14.06 L/hr
Standard Deviation 1.241
|
15.30 L/hr
Standard Deviation 2.291
|
15.44 L/hr
Standard Deviation 2.214
|
NA L/hr
Standard Deviation NA
No values were collected for placebo Arm
|
Adverse Events
Alogliptin 12.5 mg QD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Alogliptin 25 mg QD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Alogliptin 50 mg QD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alogliptin 12.5 mg QD
n=12 participants at risk
Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 25 mg QD
n=12 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
|
Alogliptin 50 mg QD
n=12 participants at risk
Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
|
Placebo
n=12 participants at risk
Placebo tablets, orally, two tablets taken once daily for up to 7 days.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
|
General disorders
Feeling cold
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
|
General disorders
Thirst
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
|
Infections and infestations
Upper Respiratory Tract Infections
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) are adverse events (AEs) with an onset after the first dose of study drug (Day 1) and up to 30 ± 2 days after the last dose of study drug.
An AE is defined as any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product.
|
Additional Information
Sr. VP, Clinical Science
Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER