Trial Outcomes & Findings for Pharmacokinetics, Pharmacodynamics, and Safety of Alogliptin in Children, Adolescents and Adults With Type 2 Diabetes Mellitus (NCT NCT00957268)
NCT ID: NCT00957268
Last Updated: 2015-01-29
Results Overview
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
46 participants
Primary outcome timeframe
1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose
Results posted on
2015-01-29
Participant Flow
Participants took part in the study at 6 investigative sites in the United States from 17 Sep 2009 to 22 Nov 2013.
Participants aged 10 to 65 with a diagnosis of type 2 diabetes mellitus were enrolled in 1 of 5 treatment groups and received 12.5 or 25 mg alogliptin once.
Participant milestones
| Measure |
Alogliptin 12.5 mg (Age 10 to < 14 Years)
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 10 to < 14 Years)
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 12.5 mg (Age 14 to < 18 Years)
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 14 to < 18 Years)
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 18 to 65 Years)
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
8
|
7
|
22
|
|
Overall Study
COMPLETED
|
5
|
4
|
7
|
7
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Alogliptin 12.5 mg (Age 10 to < 14 Years)
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 10 to < 14 Years)
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 12.5 mg (Age 14 to < 18 Years)
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 14 to < 18 Years)
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 18 to 65 Years)
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
|---|---|---|---|---|---|
|
Overall Study
Voluntary Withdrawal
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Pharmacokinetics, Pharmacodynamics, and Safety of Alogliptin in Children, Adolescents and Adults With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Alogliptin 12.5 mg (Age 10 to < 14 Years)
n=5 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 10 to < 14 Years)
n=4 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 12.5 mg (Age 14 to < 18 Years)
n=8 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 18 to 65 Years)
n=22 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
12.4 years
STANDARD_DEVIATION 0.89 • n=5 Participants
|
12.0 years
STANDARD_DEVIATION 0.82 • n=7 Participants
|
15.4 years
STANDARD_DEVIATION 0.92 • n=5 Participants
|
15.1 years
STANDARD_DEVIATION 0.69 • n=4 Participants
|
51.3 years
STANDARD_DEVIATION 8.24 • n=21 Participants
|
31.96 years
STANDARD_DEVIATION 19.67 • n=10 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
7 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic or Latino
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
6 participants
n=4 Participants
|
18 participants
n=21 Participants
|
39 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian Black or African American
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
15 participants
n=21 Participants
|
32 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
2 participants
n=4 Participants
|
7 participants
n=21 Participants
|
14 participants
n=10 Participants
|
|
Height
|
162.4 cm
STANDARD_DEVIATION 8.56 • n=5 Participants
|
165.8 cm
STANDARD_DEVIATION 8.88 • n=7 Participants
|
168.6 cm
STANDARD_DEVIATION 5.71 • n=5 Participants
|
168.9 cm
STANDARD_DEVIATION 9.03 • n=4 Participants
|
167.5 cm
STANDARD_DEVIATION 9.81 • n=21 Participants
|
167.2 cm
STANDARD_DEVIATION 8.73 • n=10 Participants
|
|
Weight
|
86.62 kg
STANDARD_DEVIATION 13.979 • n=5 Participants
|
98.90 kg
STANDARD_DEVIATION 11.957 • n=7 Participants
|
116.28 kg
STANDARD_DEVIATION 33.163 • n=5 Participants
|
103.71 kg
STANDARD_DEVIATION 17.103 • n=4 Participants
|
92.25 kg
STANDARD_DEVIATION 16.454 • n=21 Participants
|
97.14 kg
STANDARD_DEVIATION 21.409 • n=10 Participants
|
|
Body Mass Index (BMI)
|
33.22 kg/m^2
STANDARD_DEVIATION 4.621 • n=5 Participants
|
36.16 kg/m^2
STANDARD_DEVIATION 3.422 • n=7 Participants
|
40.92 kg/m^2
STANDARD_DEVIATION 9.190 • n=5 Participants
|
36.46 kg/m^2
STANDARD_DEVIATION 6.764 • n=4 Participants
|
32.84 kg/m^2
STANDARD_DEVIATION 4.490 • n=21 Participants
|
35.01 kg/m^2
STANDARD_DEVIATION 6.439 • n=10 Participants
|
|
Smoking Status
Never Smoked
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
7 participants
n=4 Participants
|
14 participants
n=21 Participants
|
38 participants
n=10 Participants
|
|
Smoking Status
Current Smoker
|
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
|
0 participants
n=10 Participants
|
|
Smoking Status
Ex-smoker
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
8 participants
n=21 Participants
|
8 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dosePopulation: Pharmacokinetic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable plasma concentration of alogliptin.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
Alogliptin 12.5 mg (Age 10 to < 14 Years)
n=5 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 10 to < 14 Years)
n=4 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 12.5 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 18 to 65 Years)
n=22 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Alogliptin
|
57.82 ng/mL
Standard Deviation 31.5546
|
101.38 ng/mL
Standard Deviation 23.4277
|
44.24 ng/mL
Standard Deviation 16.7907
|
96.74 ng/mL
Standard Deviation 28.3818
|
136.50 ng/mL
Standard Deviation 34.2169
|
PRIMARY outcome
Timeframe: 1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dosePopulation: Pharmacokinetic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable plasma concentration of alogliptin.
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Outcome measures
| Measure |
Alogliptin 12.5 mg (Age 10 to < 14 Years)
n=5 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 10 to < 14 Years)
n=4 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 12.5 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 18 to 65 Years)
n=22 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
|---|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alogliptin
|
3.24 hr
Standard Deviation 1.1060
|
2.04 hr
Standard Deviation 0.0462
|
5.58 hr
Standard Deviation 8.2052
|
2.86 hr
Standard Deviation 1.4707
|
2.09 hr
Standard Deviation 1.1566
|
PRIMARY outcome
Timeframe: 1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dosePopulation: Pharmacokinetic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable plasma concentration of alogliptin.
AUC(0-inf) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau\]), where tau is the length of the dosing interval in this study).
Outcome measures
| Measure |
Alogliptin 12.5 mg (Age 10 to < 14 Years)
n=5 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 10 to < 14 Years)
n=4 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 12.5 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 18 to 65 Years)
n=22 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
|---|---|---|---|---|---|
|
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alogliptin
|
789.29 ng•hr/mL
Standard Deviation 144.0995
|
1221.98 ng•hr/mL
Standard Deviation 128.0268
|
688.63 ng•hr/mL
Standard Deviation 188.7887
|
1318.41 ng•hr/mL
Standard Deviation 123.6279
|
1704.02 ng•hr/mL
Standard Deviation 270.6604
|
SECONDARY outcome
Timeframe: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dosePopulation: Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.
The area under the plasma effect-time curve from time 0 to 24 hours post-dose (AUEC\[0-24\]) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.
Outcome measures
| Measure |
Alogliptin 12.5 mg (Age 10 to < 14 Years)
n=5 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 10 to < 14 Years)
n=4 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 12.5 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 18 to 65 Years)
n=22 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition
|
1569.633 Percentage inhibition•hr
Standard Deviation 115.9662
|
1698.852 Percentage inhibition•hr
Standard Deviation 74.1622
|
1557.788 Percentage inhibition•hr
Standard Deviation 179.5170
|
1854.391 Percentage inhibition•hr
Standard Deviation 63.7486
|
1890.012 Percentage inhibition•hr
Standard Deviation 71.4549
|
SECONDARY outcome
Timeframe: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dosePopulation: Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.
The maximum observed effect (Emax) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.
Outcome measures
| Measure |
Alogliptin 12.5 mg (Age 10 to < 14 Years)
n=5 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 10 to < 14 Years)
n=4 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 12.5 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 18 to 65 Years)
n=22 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
|---|---|---|---|---|---|
|
Maximum Observed Effect (Emax) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition
|
83.660 Percentage inhibition
Standard Deviation 4.1446
|
89.300 Percentage inhibition
Standard Deviation 2.6420
|
81.643 Percentage inhibition
Standard Deviation 5.9267
|
90.429 Percentage inhibition
Standard Deviation 1.7327
|
92.650 Percentage inhibition
Standard Deviation 2.0068
|
SECONDARY outcome
Timeframe: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dosePopulation: Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.
The time to reach the maximum observed effect of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.
Outcome measures
| Measure |
Alogliptin 12.5 mg (Age 10 to < 14 Years)
n=5 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 10 to < 14 Years)
n=4 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 12.5 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 18 to 65 Years)
n=22 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
|---|---|---|---|---|---|
|
Time to Reach the Maximum Observed Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibition
|
4.050 hr
Interval 2.0 to 4.08
|
2.080 hr
Interval 2.0 to 4.0
|
4.000 hr
Interval 2.0 to 4.03
|
4.000 hr
Interval 3.97 to 4.12
|
2.000 hr
Interval 2.0 to 4.07
|
SECONDARY outcome
Timeframe: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dosePopulation: Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.
The observed effect at 24 hours post-dose (E24) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.
Outcome measures
| Measure |
Alogliptin 12.5 mg (Age 10 to < 14 Years)
n=5 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 10 to < 14 Years)
n=4 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 12.5 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 18 to 65 Years)
n=21 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
|---|---|---|---|---|---|
|
Observed Effect at 24 Hours Post-dose (E24) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition
|
52.000 Percentage inhibition
Standard Deviation 10.2976
|
57.375 Percentage inhibition
Standard Deviation 5.1292
|
55.400 Percentage inhibition
Standard Deviation 9.0239
|
70.400 Percentage inhibition
Standard Deviation 5.7660
|
72.843 Percentage inhibition
Standard Deviation 5.2949
|
SECONDARY outcome
Timeframe: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dosePopulation: Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.
The area under the plasma effect-time curve from time 0 to 24 hours post-dose (AUEC\[0-24\]) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.
Outcome measures
| Measure |
Alogliptin 12.5 mg (Age 10 to < 14 Years)
n=5 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 10 to < 14 Years)
n=4 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 12.5 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 18 to 65 Years)
n=21 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration
|
117.842 pmol•hr/L
Standard Deviation 92.8964
|
120.055 pmol•hr/L
Standard Deviation 60.6825
|
168.099 pmol•hr/L
Standard Deviation 116.2830
|
122.948 pmol•hr/L
Standard Deviation 98.3822
|
278.669 pmol•hr/L
Standard Deviation 102.3304
|
SECONDARY outcome
Timeframe: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dosePopulation: Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.
The maximum observed effect (Emax) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.
Outcome measures
| Measure |
Alogliptin 12.5 mg (Age 10 to < 14 Years)
n=5 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 10 to < 14 Years)
n=4 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 12.5 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 18 to 65 Years)
n=21 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
|---|---|---|---|---|---|
|
Maximum Observed Effect (Emax) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration
|
11.700 pmol/L
Standard Deviation 4.6357
|
7.475 pmol/L
Standard Deviation 3.8767
|
16.500 pmol/L
Standard Deviation 15.0423
|
9.129 pmol/L
Standard Deviation 6.6668
|
23.843 pmol/L
Standard Deviation 12.1143
|
SECONDARY outcome
Timeframe: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dosePopulation: Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.
The time to reach the maximum observed effect of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.
Outcome measures
| Measure |
Alogliptin 12.5 mg (Age 10 to < 14 Years)
n=5 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 10 to < 14 Years)
n=4 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 12.5 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 18 to 65 Years)
n=21 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
|---|---|---|---|---|---|
|
Time to Reach the Maximum Observed Effect of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration
|
8.170 hr
Interval 8.03 to 12.0
|
11.985 hr
Interval 8.0 to 12.0
|
11.920 hr
Interval 8.0 to 12.0
|
8.020 hr
Interval 4.0 to 24.0
|
12.000 hr
Interval 2.33 to 24.02
|
SECONDARY outcome
Timeframe: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dosePopulation: Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.
The observed effect at 24 hours post-dose (E24) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.
Outcome measures
| Measure |
Alogliptin 12.5 mg (Age 10 to < 14 Years)
n=5 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 10 to < 14 Years)
n=4 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 12.5 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 14 to < 18 Years)
n=7 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 18 to 65 Years)
n=21 Participants
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
|---|---|---|---|---|---|
|
Observed Effect at 24 Hours Post-dose (E24) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration
|
2.500 pmol/L
Standard Deviation 5.3282
|
4.575 pmol/L
Standard Deviation 3.6372
|
4.214 pmol/L
Standard Deviation 5.2737
|
4.329 pmol/L
Standard Deviation 6.2203
|
5.419 pmol/L
Standard Deviation 6.2064
|
Adverse Events
Alogliptin 12.5 mg (Age 10 to < 14 Years)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Alogliptin 25 mg (Age 10 to < 14 Years)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Alogliptin 12.5 mg (Age 14 to < 18 Years)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Alogliptin 25 mg (Age 14 to < 18 Years)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Alogliptin 25 mg (Age 18 to 65 Years)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alogliptin 12.5 mg (Age 10 to < 14 Years)
n=5 participants at risk
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 10 to < 14 Years)
n=4 participants at risk
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 12.5 mg (Age 14 to < 18 Years)
n=8 participants at risk
Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 14 to < 18 Years)
n=7 participants at risk
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
Alogliptin 25 mg (Age 18 to 65 Years)
n=22 participants at risk
Alogliptin 25 mg QD, tablets, orally, 1 dose only.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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.
|
25.0%
2/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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%
0/22
Safety set: All enrolled participants who received at least 1 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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%
0/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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.
|
4.5%
1/22
Safety set: All enrolled participants who received at least 1 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.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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.
|
12.5%
1/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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%
0/22
Safety set: All enrolled participants who received at least 1 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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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.
|
12.5%
1/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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.
|
9.1%
2/22
Safety set: All enrolled participants who received at least 1 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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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.
|
12.5%
1/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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%
0/22
Safety set: All enrolled participants who received at least 1 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.
|
|
General disorders
Fatigue
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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%
0/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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.
|
9.1%
2/22
Safety set: All enrolled participants who received at least 1 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.
|
|
General disorders
Pyrexia
|
20.0%
1/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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%
0/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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%
0/22
Safety set: All enrolled participants who received at least 1 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.
|
|
Infections and infestations
Viral infection
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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.
|
12.5%
1/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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%
0/22
Safety set: All enrolled participants who received at least 1 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 creatine phosphokinase increased
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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%
0/8
Safety set: All enrolled participants who received at least 1 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.
|
14.3%
1/7
Safety set: All enrolled participants who received at least 1 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%
0/22
Safety set: All enrolled participants who received at least 1 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
Haematocrit decreased
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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%
0/8
Safety set: All enrolled participants who received at least 1 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.
|
14.3%
1/7
Safety set: All enrolled participants who received at least 1 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%
0/22
Safety set: All enrolled participants who received at least 1 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
Haemoglobin decreased
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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%
0/8
Safety set: All enrolled participants who received at least 1 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.
|
14.3%
1/7
Safety set: All enrolled participants who received at least 1 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%
0/22
Safety set: All enrolled participants who received at least 1 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
Neutrophil count decreased
|
20.0%
1/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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%
0/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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%
0/22
Safety set: All enrolled participants who received at least 1 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%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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.
|
12.5%
1/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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.
|
18.2%
4/22
Safety set: All enrolled participants who received at least 1 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
Presyncope
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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.
|
12.5%
1/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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%
0/22
Safety set: All enrolled participants who received at least 1 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.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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.
|
25.0%
1/4
Safety set: All enrolled participants who received at least 1 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%
0/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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%
0/22
Safety set: All enrolled participants who received at least 1 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.
|
|
General disorders
Nodule
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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%
0/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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.
|
4.5%
1/22
Safety set: All enrolled participants who received at least 1 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.
|
|
General disorders
Tenderness
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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%
0/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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.
|
4.5%
1/22
Safety set: All enrolled participants who received at least 1 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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%
0/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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.
|
4.5%
1/22
Safety set: All enrolled participants who received at least 1 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.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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%
0/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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.
|
4.5%
1/22
Safety set: All enrolled participants who received at least 1 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.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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%
0/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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.
|
4.5%
1/22
Safety set: All enrolled participants who received at least 1 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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%
0/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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.
|
4.5%
1/22
Safety set: All enrolled participants who received at least 1 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
Dysgeusia
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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%
0/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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.
|
4.5%
1/22
Safety set: All enrolled participants who received at least 1 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
Tremor
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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%
0/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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.
|
4.5%
1/22
Safety set: All enrolled participants who received at least 1 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.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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%
0/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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.
|
4.5%
1/22
Safety set: All enrolled participants who received at least 1 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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/5
Safety set: All enrolled participants who received at least 1 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%
0/4
Safety set: All enrolled participants who received at least 1 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%
0/8
Safety set: All enrolled participants who received at least 1 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%
0/7
Safety set: All enrolled participants who received at least 1 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.
|
4.5%
1/22
Safety set: All enrolled participants who received at least 1 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 therefrom 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