Trial Outcomes & Findings for A Study in Healthy Subjects to Assess Drug Availability of 4 Different Formulations of Verinurad and Allopurinol (NCT NCT04550234)
NCT ID: NCT04550234
Last Updated: 2023-05-10
Results Overview
The AUCinf of verinurad, allopurinol and oxypurinol were assessed in fasted state as PK parameters
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Day 1, Day 2, Day 3 and Day 4 of each Treatment Period
Results posted on
2023-05-10
Participant Flow
The study was conducted between 13 April 2021 to 15 July 2021.
Subjects who met all the inclusion and none of the exclusion criteria were randomized at single center. The screening period was from Day -28 to Day -3. Informed consent form (ICF) was signed prior to screening procedures. All the study assessments were performed as per the schedule of assessment.
Participant milestones
| Measure |
Treatment Sequence 12345
Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \[Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state; Treatment 2: verinurad/allopurinol FDC capsule, fasted state; Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state; Treatment 5: verinurad prolonged release gelatin capsule, fasted state\] on Day 1 separated by at least 5 days washout between IMP administration.
|
Treatment Sequence 23451
Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \[Treatment 2: verinurad/allopurinol FDC capsule, fasted state; Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state; Treatment 5: verinurad prolonged release gelatin capsule, fasted state; Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state\] on Day 1 separated by at least 5 days washout between IMP administration.
|
Treatment Sequence 34512
Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \[Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state; Treatment 5: verinurad prolonged release gelatin capsule, fasted state; Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state; Treatment 2: verinurad/allopurinol FDC capsule, fasted state\] on Day 1 separated by at least 5 days washout between IMP administration.
|
Treatment Sequence 45123
Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \[Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state; Treatment 5: verinurad prolonged release gelatin capsule, fasted state; Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state; Treatment 2: verinurad/allopurinol FDC capsule, fasted state\] on Day 1 separated by at least 5 days washout between IMP administration.
|
Treatment Sequence 51234
Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \[Treatment 5: verinurad prolonged release gelatin capsule, fasted state; Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state; Treatment 2: verinurad/allopurinol FDC capsule, fasted state; Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state\] on Day 1 separated by at least 5 days washout between IMP administration.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Subjects to Assess Drug Availability of 4 Different Formulations of Verinurad and Allopurinol
Baseline characteristics by cohort
| Measure |
Treatment Sequence 12345
n=5 Participants
Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \[Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state; Treatment 2: verinurad/allopurinol FDC capsule, fasted state; Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state; Treatment 5: verinurad prolonged release gelatin capsule, fasted state\] on Day 1 separated by at least 5 days washout between IMP administration.
|
Treatment Sequence 23451
n=5 Participants
Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \[Treatment 2: verinurad/allopurinol FDC capsule, fasted state; Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state; Treatment 5: verinurad prolonged release gelatin capsule, fasted state; Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state\] on Day 1 separated by at least 5 days washout between IMP administration.
|
Treatment Sequence 34512
n=5 Participants
Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \[Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state; Treatment 5: verinurad prolonged release gelatin capsule, fasted state; Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state; Treatment 2: verinurad/allopurinol FDC capsule, fasted state\] on Day 1 separated by at least 5 days washout between IMP administration.
|
Treatment Sequence 45123
n=5 Participants
Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \[Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state; Treatment 5: verinurad prolonged release gelatin capsule, fasted state; Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state; Treatment 2: verinurad/allopurinol FDC capsule, fasted state\] on Day 1 separated by at least 5 days washout between IMP administration.
|
Treatment Sequence 51234
n=5 Participants
Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \[Treatment 5: verinurad prolonged release gelatin capsule, fasted state; Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state; Treatment 2: verinurad/allopurinol FDC capsule, fasted state; Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state\] on Day 1 separated by at least 5 days washout between IMP administration.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
31.4 Years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
34.2 Years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
26.0 Years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
33.0 Years
STANDARD_DEVIATION 4.7 • n=4 Participants
|
38.4 Years
STANDARD_DEVIATION 10.6 • n=21 Participants
|
32.6 Years
STANDARD_DEVIATION 8.0 • n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 2, Day 3 and Day 4 of each Treatment PeriodPopulation: The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration. Here, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.
The AUCinf of verinurad, allopurinol and oxypurinol were assessed in fasted state as PK parameters
Outcome measures
| Measure |
Treatment 1
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1
|
Treatment 2
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1
|
Treatment 3
Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1
|
Treatment 4
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1
|
Treatment 5
Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1
|
|---|---|---|---|---|---|
|
AUCinf: Area Under Plasma Concentration-time Curve From 0 to Infinity in Fasted Condition
Verinurad
|
180.4 hour*nanogram/millilitre
Geometric Coefficient of Variation 48.87
|
195.2 hour*nanogram/millilitre
Geometric Coefficient of Variation 48.63
|
—
|
—
|
—
|
|
AUCinf: Area Under Plasma Concentration-time Curve From 0 to Infinity in Fasted Condition
Allopurinol
|
4486 hour*nanogram/millilitre
Geometric Coefficient of Variation 37.86
|
4332 hour*nanogram/millilitre
Geometric Coefficient of Variation 46.40
|
—
|
—
|
—
|
|
AUCinf: Area Under Plasma Concentration-time Curve From 0 to Infinity in Fasted Condition
Oxypurinol
|
170100 hour*nanogram/millilitre
Geometric Coefficient of Variation 19.07
|
167900 hour*nanogram/millilitre
Geometric Coefficient of Variation 24.10
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1, Day 2, Day 3 and Day 4 of each Treatment PeriodPopulation: The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration. Here, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.
The AUClast of verinurad, allopurinol and oxypurinol were assessed in fasted condition as PK parameters
Outcome measures
| Measure |
Treatment 1
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1
|
Treatment 2
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1
|
Treatment 3
Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1
|
Treatment 4
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1
|
Treatment 5
Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1
|
|---|---|---|---|---|---|
|
AUClast: Area Under Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration in Fasted Condition
Verinurad
|
169.3 hour*nanogram/milliliter
Geometric Coefficient of Variation 47.82
|
185.0 hour*nanogram/milliliter
Geometric Coefficient of Variation 49.64
|
—
|
—
|
—
|
|
AUClast: Area Under Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration in Fasted Condition
Allopurinol
|
4407 hour*nanogram/milliliter
Geometric Coefficient of Variation 37.98
|
4251 hour*nanogram/milliliter
Geometric Coefficient of Variation 46.91
|
—
|
—
|
—
|
|
AUClast: Area Under Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration in Fasted Condition
Oxypurinol
|
157100 hour*nanogram/milliliter
Geometric Coefficient of Variation 16.84
|
153100 hour*nanogram/milliliter
Geometric Coefficient of Variation 21.35
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1, Day 2, Day 3 and Day 4 of each Treatment PeriodPopulation: The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration. Here, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.
The Cmax of verinurad, allopurinol and oxypurinol were assessed in fasted state as PK parameters
Outcome measures
| Measure |
Treatment 1
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1
|
Treatment 2
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1
|
Treatment 3
Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1
|
Treatment 4
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1
|
Treatment 5
Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1
|
|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Drug Concentration in Fasted State
Verinurad
|
26.62 nanogram/millilitre
Geometric Coefficient of Variation 50.71
|
34.95 nanogram/millilitre
Geometric Coefficient of Variation 61.87
|
—
|
—
|
—
|
|
Cmax: Maximum Observed Plasma Drug Concentration in Fasted State
Allopurinol
|
1526 nanogram/millilitre
Geometric Coefficient of Variation 37.98
|
1471 nanogram/millilitre
Geometric Coefficient of Variation 42.92
|
—
|
—
|
—
|
|
Cmax: Maximum Observed Plasma Drug Concentration in Fasted State
Oxypurinol
|
6376 nanogram/millilitre
Geometric Coefficient of Variation 16.67
|
6066 nanogram/millilitre
Geometric Coefficient of Variation 21.61
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3 and Day 4 of each Treatment PeriodPopulation: The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration. Here, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.
The Cmax of verinurad, allopurinol and oxypurinol were assessed as PK parameters
Outcome measures
| Measure |
Treatment 1
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1
|
Treatment 2
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1
|
Treatment 3
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1
|
Treatment 4
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1
|
Treatment 5
n=25 Participants
Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1
|
|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Drug Concentration
Verinurad
|
26.62 nanogram/millilitre
Geometric Coefficient of Variation 50.71
|
34.95 nanogram/millilitre
Geometric Coefficient of Variation 61.87
|
20.18 nanogram/millilitre
Geometric Coefficient of Variation 70.96
|
13.86 nanogram/millilitre
Geometric Coefficient of Variation 68.98
|
35.35 nanogram/millilitre
Geometric Coefficient of Variation 44.84
|
|
Cmax: Maximum Observed Plasma Drug Concentration
Allopurinol
|
1526 nanogram/millilitre
Geometric Coefficient of Variation 37.98
|
1471 nanogram/millilitre
Geometric Coefficient of Variation 42.92
|
1079 nanogram/millilitre
Geometric Coefficient of Variation 68.87
|
1627 nanogram/millilitre
Geometric Coefficient of Variation 43.71
|
NA nanogram/millilitre
Geometric Coefficient of Variation NA
As, subjects received only verinurad, hence this is not applicable
|
|
Cmax: Maximum Observed Plasma Drug Concentration
Oxypurinol
|
6376 nanogram/millilitre
Geometric Coefficient of Variation 16.67
|
6066 nanogram/millilitre
Geometric Coefficient of Variation 21.61
|
5269 nanogram/millilitre
Geometric Coefficient of Variation 19.91
|
5709 nanogram/millilitre
Geometric Coefficient of Variation 21.21
|
NA nanogram/millilitre
Geometric Coefficient of Variation NA
As, subjects received only verinurad, hence this is not applicable
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3 and Day 4 of each Treatment PeriodPopulation: The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration. Here, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.
The AUCinf of verinurad, allopurinol and oxypurinol were assessed as PK parameters
Outcome measures
| Measure |
Treatment 1
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1
|
Treatment 2
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1
|
Treatment 3
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1
|
Treatment 4
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1
|
Treatment 5
n=25 Participants
Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1
|
|---|---|---|---|---|---|
|
AUCinf: Area Under Plasma Concentration-time Curve From 0 to Infinity
Oxypurinol
|
170100 hour*nanogram/millilitre
Geometric Coefficient of Variation 19.07
|
167900 hour*nanogram/millilitre
Geometric Coefficient of Variation 24.10
|
153200 hour*nanogram/millilitre
Geometric Coefficient of Variation 24.22
|
153300 hour*nanogram/millilitre
Geometric Coefficient of Variation 22.74
|
NA hour*nanogram/millilitre
Geometric Coefficient of Variation NA
As, subjects received only verinurad, hence this is not applicable
|
|
AUCinf: Area Under Plasma Concentration-time Curve From 0 to Infinity
Verinurad
|
180.4 hour*nanogram/millilitre
Geometric Coefficient of Variation 48.87
|
195.2 hour*nanogram/millilitre
Geometric Coefficient of Variation 48.63
|
200.1 hour*nanogram/millilitre
Geometric Coefficient of Variation 54.89
|
138.4 hour*nanogram/millilitre
Geometric Coefficient of Variation 64.06
|
187.8 hour*nanogram/millilitre
Geometric Coefficient of Variation 40.22
|
|
AUCinf: Area Under Plasma Concentration-time Curve From 0 to Infinity
Allopurinol
|
4486 hour*nanogram/millilitre
Geometric Coefficient of Variation 37.86
|
4332 hour*nanogram/millilitre
Geometric Coefficient of Variation 46.40
|
3551 hour*nanogram/millilitre
Geometric Coefficient of Variation 37.17
|
4114 hour*nanogram/millilitre
Geometric Coefficient of Variation 35.79
|
NA hour*nanogram/millilitre
Geometric Coefficient of Variation NA
As, subjects received only verinurad, hence this is not applicable
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3 and Day 4 of each Treatment PeriodPopulation: The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration. Here, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.
The AUClast of verinurad, allopurinol and oxypurinol were assessed as PK parameters
Outcome measures
| Measure |
Treatment 1
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1
|
Treatment 2
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1
|
Treatment 3
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1
|
Treatment 4
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1
|
Treatment 5
n=25 Participants
Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1
|
|---|---|---|---|---|---|
|
AUClast: Area Under Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration
Allopurinol
|
4407 hour*nanogram/milliliter
Geometric Coefficient of Variation 37.98
|
4251 hour*nanogram/milliliter
Geometric Coefficient of Variation 46.91
|
3512 hour*nanogram/milliliter
Geometric Coefficient of Variation 45.13
|
4030 hour*nanogram/milliliter
Geometric Coefficient of Variation 35.80
|
NA hour*nanogram/milliliter
Geometric Coefficient of Variation NA
As, subjects received only verinurad, hence this is not applicable
|
|
AUClast: Area Under Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration
Oxypurinol
|
157100 hour*nanogram/milliliter
Geometric Coefficient of Variation 16.84
|
153100 hour*nanogram/milliliter
Geometric Coefficient of Variation 21.35
|
139200 hour*nanogram/milliliter
Geometric Coefficient of Variation 21.05
|
140100 hour*nanogram/milliliter
Geometric Coefficient of Variation 19.57
|
NA hour*nanogram/milliliter
Geometric Coefficient of Variation NA
As, subjects received only verinurad, hence this is not applicable
|
|
AUClast: Area Under Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration
Verinurad
|
169.3 hour*nanogram/milliliter
Geometric Coefficient of Variation 47.82
|
185.0 hour*nanogram/milliliter
Geometric Coefficient of Variation 49.64
|
190.3 hour*nanogram/milliliter
Geometric Coefficient of Variation 55.76
|
129.9 hour*nanogram/milliliter
Geometric Coefficient of Variation 65.65
|
176.4 hour*nanogram/milliliter
Geometric Coefficient of Variation 39.80
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3 and Day 4 of each Treatment PeriodPopulation: The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration. Here, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.
The tmax of verinurad, allopurinol and oxypurinol were assessed as PK parameters
Outcome measures
| Measure |
Treatment 1
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1
|
Treatment 2
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1
|
Treatment 3
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1
|
Treatment 4
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1
|
Treatment 5
n=25 Participants
Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1
|
|---|---|---|---|---|---|
|
Tmax: Time to Reach Maximum Observed Plasma Concentration Following Drug Administration
Oxypurinol
|
4.00 hour
Interval 1.0 to 6.0
|
4.00 hour
Interval 2.12 to 8.02
|
6.02 hour
Interval 1.0 to 12.03
|
4.00 hour
Interval 0.52 to 10.02
|
NA hour
As, subjects received only verinurad, hence this is not applicable
|
|
Tmax: Time to Reach Maximum Observed Plasma Concentration Following Drug Administration
Verinurad
|
5.00 hour
Interval 3.0 to 6.02
|
4.00 hour
Interval 2.0 to 5.08
|
9.98 hour
Interval 3.0 to 12.03
|
5.03 hour
Interval 4.0 to 10.02
|
4.00 hour
Interval 2.0 to 6.0
|
|
Tmax: Time to Reach Maximum Observed Plasma Concentration Following Drug Administration
Allopurinol
|
1.50 hour
Interval 0.5 to 3.02
|
1.50 hour
Interval 0.5 to 4.02
|
3.00 hour
Interval 0.5 to 10.0
|
1.50 hour
Interval 0.5 to 5.0
|
NA hour
As, subjects received only verinurad, hence this is not applicable
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3 and Day 4 of each Treatment PeriodPopulation: The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration. Here, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.
The tlag of verinurad, allopurinol and oxypurinol were assessed as PK parameters
Outcome measures
| Measure |
Treatment 1
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1
|
Treatment 2
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1
|
Treatment 3
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1
|
Treatment 4
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1
|
Treatment 5
n=25 Participants
Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1
|
|---|---|---|---|---|---|
|
Tlag: Time Delay Between Drug Administration and First Observed Concentration in Plasma
Verinurad
|
0.00 hour
Interval 0.0 to 0.5
|
0.00 hour
Interval 0.0 to 1.0
|
1.00 hour
Interval 0.0 to 2.02
|
1.02 hour
Interval 0.0 to 2.0
|
0.00 hour
Interval 0.0 to 0.5
|
|
Tlag: Time Delay Between Drug Administration and First Observed Concentration in Plasma
Allopurinol
|
0.00 hour
Interval 0.0 to 0.5
|
0.00 hour
Interval 0.0 to 1.0
|
1.02 hour
Interval 0.0 to 4.0
|
0.00 hour
Interval 0.0 to 1.02
|
NA hour
As, subjects received only verinurad, hence this is not applicable
|
|
Tlag: Time Delay Between Drug Administration and First Observed Concentration in Plasma
Oxypurinol
|
0.00 hour
Interval 0.0 to 0.0
|
0.00 hour
Interval 0.0 to 0.0
|
0.00 hour
Interval 0.0 to 1.0
|
0.00 hour
Interval 0.0 to 0.0
|
NA hour
As, subjects received only verinurad, hence this is not applicable
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3 and Day 4 of each Treatment PeriodPopulation: The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration. Here, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.
The t½λz of verinurad, allopurinol and oxypurinol were assessed as PK parameters
Outcome measures
| Measure |
Treatment 1
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1
|
Treatment 2
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1
|
Treatment 3
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1
|
Treatment 4
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1
|
Treatment 5
n=25 Participants
Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1
|
|---|---|---|---|---|---|
|
t½λz: Half-life Associated With Terminal Slope (λz) of Semi-logarithmic Concentration-time Curve
Verinurad
|
15.57 hour
Geometric Coefficient of Variation 53.19
|
14.17 hour
Geometric Coefficient of Variation 58.62
|
13.69 hour
Geometric Coefficient of Variation 57.74
|
13.77 hour
Geometric Coefficient of Variation 61.38
|
14.71 hour
Geometric Coefficient of Variation 61.15
|
|
t½λz: Half-life Associated With Terminal Slope (λz) of Semi-logarithmic Concentration-time Curve
Allopurinol
|
1.164 hour
Geometric Coefficient of Variation 21.78
|
1.142 hour
Geometric Coefficient of Variation 19.13
|
1.696 hour
Geometric Coefficient of Variation 56.37
|
1.085 hour
Geometric Coefficient of Variation 24.91
|
NA hour
Geometric Coefficient of Variation NA
As, subjects received only verinurad, hence this is not applicable
|
|
t½λz: Half-life Associated With Terminal Slope (λz) of Semi-logarithmic Concentration-time Curve
Oxypurinol
|
19.06 hour
Geometric Coefficient of Variation 19.81
|
20.45 hour
Geometric Coefficient of Variation 22.87
|
20.14 hour
Geometric Coefficient of Variation 23.18
|
20.21 hour
Geometric Coefficient of Variation 23.00
|
NA hour
Geometric Coefficient of Variation NA
As, subjects received only verinurad, hence this is not applicable
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3 and Day 4 of each Treatment PeriodPopulation: The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration. Here, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.
The λz of verinurad, allopurinol and oxypurinol were assessed as PK parameters
Outcome measures
| Measure |
Treatment 1
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1
|
Treatment 2
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1
|
Treatment 3
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1
|
Treatment 4
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1
|
Treatment 5
n=25 Participants
Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1
|
|---|---|---|---|---|---|
|
λz: Terminal Elimination Rate Constant
Verinurad
|
0.04437 per hour
Geometric Coefficient of Variation 55.10
|
0.04876 per hour
Geometric Coefficient of Variation 65.26
|
0.04957 per hour
Geometric Coefficient of Variation 61.83
|
0.05063 per hour
Geometric Coefficient of Variation 57.34
|
0.04651 per hour
Geometric Coefficient of Variation 60.92
|
|
λz: Terminal Elimination Rate Constant
Allopurinol
|
0.5951 per hour
Geometric Coefficient of Variation 21.96
|
0.6065 per hour
Geometric Coefficient of Variation 18.98
|
0.4075 per hour
Geometric Coefficient of Variation 57.03
|
0.6384 per hour
Geometric Coefficient of Variation 25.11
|
NA per hour
Geometric Coefficient of Variation NA
As, subjects received only verinurad, hence this is not applicable
|
|
λz: Terminal Elimination Rate Constant
Oxypurinol
|
0.03653 per hour
Geometric Coefficient of Variation 19.58
|
0.03309 per hour
Geometric Coefficient of Variation 24.22
|
0.03512 per hour
Geometric Coefficient of Variation 23.12
|
0.03425 per hour
Geometric Coefficient of Variation 24.67
|
NA per hour
Geometric Coefficient of Variation NA
As, subjects received only verinurad, hence this is not applicable
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3 and Day 4 of each Treatment PeriodPopulation: The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration. Here, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.
The CL/F of verinurad and allopurinol were assessed as PK parameters
Outcome measures
| Measure |
Treatment 1
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1
|
Treatment 2
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1
|
Treatment 3
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1
|
Treatment 4
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1
|
Treatment 5
n=25 Participants
Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1
|
|---|---|---|---|---|---|
|
CL/F: Apparent Total Body Clearance of Drug Clearance of Drug From Plasma After Extravascular Administration
Verinurad
|
66.54 Liter/hour
Geometric Coefficient of Variation 48.87
|
61.46 Liter/hour
Geometric Coefficient of Variation 48.63
|
59.97 Liter/hour
Geometric Coefficient of Variation 54.90
|
86.73 Liter/hour
Geometric Coefficient of Variation 64.06
|
63.90 Liter/hour
Geometric Coefficient of Variation 40.22
|
|
CL/F: Apparent Total Body Clearance of Drug Clearance of Drug From Plasma After Extravascular Administration
Allopurinol
|
66.88 Liter/hour
Geometric Coefficient of Variation 37.85
|
69.25 Liter/hour
Geometric Coefficient of Variation 46.40
|
84.47 Liter/hour
Geometric Coefficient of Variation 37.17
|
72.93 Liter/hour
Geometric Coefficient of Variation 35.78
|
NA Liter/hour
Geometric Coefficient of Variation NA
As, subjects received only verinurad, hence this is not applicable
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3 and Day 4 of each Treatment PeriodPopulation: The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration. Here, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.
The MRTinf of verinurad and allopurinol were assessed as PK parameters
Outcome measures
| Measure |
Treatment 1
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1
|
Treatment 2
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1
|
Treatment 3
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1
|
Treatment 4
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1
|
Treatment 5
n=25 Participants
Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1
|
|---|---|---|---|---|---|
|
MRTinf: Mean Residence Time of the Unchanged Drug in the Systemic Circulation From Zero to Infinity
Verinurad
|
18.99 hour
Geometric Coefficient of Variation 41.94
|
15.28 hour
Geometric Coefficient of Variation 43.14
|
18.91 hour
Geometric Coefficient of Variation 40.50
|
18.19 hour
Geometric Coefficient of Variation 38.37
|
15.94 hour
Geometric Coefficient of Variation 52.27
|
|
MRTinf: Mean Residence Time of the Unchanged Drug in the Systemic Circulation From Zero to Infinity
Allopurinol
|
2.629 hour
Geometric Coefficient of Variation 18.88
|
2.950 hour
Geometric Coefficient of Variation 23.30
|
4.626 hour
Geometric Coefficient of Variation 43.33
|
2.827 hour
Geometric Coefficient of Variation 37.87
|
NA hour
Geometric Coefficient of Variation NA
As, subjects received only verinurad, hence this is not applicable
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3 and Day 4 of each Treatment PeriodPopulation: The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration. Here, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.
The Vz/F of verinurad and allopurinol were assessed as PK parameters
Outcome measures
| Measure |
Treatment 1
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1
|
Treatment 2
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1
|
Treatment 3
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1
|
Treatment 4
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1
|
Treatment 5
n=25 Participants
Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1
|
|---|---|---|---|---|---|
|
Vz/F: Apparent Volume of Distribution During Terminal Phase After Extravascular Administration
Allopurinol
|
112.4 Liter
Geometric Coefficient of Variation 31.38
|
114.2 Liter
Geometric Coefficient of Variation 42.56
|
206.7 Liter
Geometric Coefficient of Variation 80.39
|
114.1 Liter
Geometric Coefficient of Variation 31.60
|
NA Liter
Geometric Coefficient of Variation NA
As, subjects received only verinurad, hence this is not applicable
|
|
Vz/F: Apparent Volume of Distribution During Terminal Phase After Extravascular Administration
Verinurad
|
1495 Liter
Geometric Coefficient of Variation 62.63
|
1256 Liter
Geometric Coefficient of Variation 69.76
|
1184 Liter
Geometric Coefficient of Variation 74.23
|
1723 Liter
Geometric Coefficient of Variation 89.59
|
1356 Liter
Geometric Coefficient of Variation 55.95
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3 and Day 4 of each Treatment PeriodPopulation: The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration. Here, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.
The Vss/F of verinurad and allopurinol were assessed as PK parameters
Outcome measures
| Measure |
Treatment 1
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1
|
Treatment 2
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1
|
Treatment 3
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1
|
Treatment 4
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1
|
Treatment 5
n=25 Participants
Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1
|
|---|---|---|---|---|---|
|
Vss/F: Apparent Volume of Distribution at Steady State Following Extravascular Administration
Verinurad
|
1264 Liter
Geometric Coefficient of Variation 55.42
|
939.3 Liter
Geometric Coefficient of Variation 62.63
|
1134 Liter
Geometric Coefficient of Variation 65.96
|
1578 Liter
Geometric Coefficient of Variation 76.33
|
1018 Liter
Geometric Coefficient of Variation 50.97
|
|
Vss/F: Apparent Volume of Distribution at Steady State Following Extravascular Administration
Allopurinol
|
175.8 Liter
Geometric Coefficient of Variation 37.01
|
204.3 Liter
Geometric Coefficient of Variation 38.33
|
390.7 Liter
Geometric Coefficient of Variation 65.33
|
206.1 Liter
Geometric Coefficient of Variation 45.73
|
NA Liter
Geometric Coefficient of Variation NA
As, subjects received only verinurad, hence this is not applicable
|
SECONDARY outcome
Timeframe: Day -1, Day 1, Day 2, Day 3 and Day 4 of each Treatment PeriodPopulation: The PD analysis set consisted of all subjects in the safety analysis set who received at least one of the verinurad and allopurinol (or verinurad alone for Treatment 5) doses and who had at least one quantifiable time-matched sUA concentration. Here, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.
The Emax, CB in serum uric acid (sUA) concentration (time-matched, Day -1) was assessed as PD parameter.
Outcome measures
| Measure |
Treatment 1
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1
|
Treatment 2
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1
|
Treatment 3
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1
|
Treatment 4
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1
|
Treatment 5
n=25 Participants
Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1
|
|---|---|---|---|---|---|
|
Emax, CB: Maximum Percentage Change From Baseline (CB)
|
-50.44 percentage (%)
Standard Deviation 8.304
|
-53.84 percentage (%)
Standard Deviation 9.947
|
-56.63 percentage (%)
Standard Deviation 9.618
|
-54.43 percentage (%)
Standard Deviation 8.895
|
-38.15 percentage (%)
Standard Deviation 9.724
|
SECONDARY outcome
Timeframe: Day -1, Day 1, Day 2, Day 3 and Day 4 of each Treatment PeriodPopulation: The PD analysis set consisted of all subjects in the safety analysis set who received at least one of the verinurad and allopurinol (or verinurad alone for Treatment 5) doses and who had at least one quantifiable time-matched sUA concentration. Here, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.
The tEmax, CB in serum uric acid (sUA) concentration (time-matched, Day -1) was assessed as PD parameter.
Outcome measures
| Measure |
Treatment 1
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1
|
Treatment 2
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1
|
Treatment 3
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1
|
Treatment 4
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1
|
Treatment 5
n=25 Participants
Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1
|
|---|---|---|---|---|---|
|
tEmax, CB: Time of Maximum Percentage CB Change From Baseline (CB)
|
8.00 hour
Interval 6.0 to 48.0
|
6.00 hour
Interval 6.0 to 48.0
|
12.00 hour
Interval 6.0 to 48.0
|
12.00 hour
Interval 8.0 to 12.0
|
12.00 hour
Interval 4.0 to 48.0
|
SECONDARY outcome
Timeframe: From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)Population: The safety analysis set included all subjects who received at least one dose of IMP and for whom any safety post-dose data were available. Here, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.
The safety of single doses of verinurad and allopurinol were assessed
Outcome measures
| Measure |
Treatment 1
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1
|
Treatment 2
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1
|
Treatment 3
n=25 Participants
Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1
|
Treatment 4
n=25 Participants
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1
|
Treatment 5
n=25 Participants
Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1
|
|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events
Any SAE with outcome of death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events
Any possibly related SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events
Any AE
|
8 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
|
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events
Any AE leading to discontinuation of IP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events
Any possibly related AE
|
3 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
Adverse Events
Treatment 1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Treatment 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment 3
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment 4
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment 5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment 1
n=25 participants at risk
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1
|
Treatment 2
n=25 participants at risk
Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1
|
Treatment 3
n=25 participants at risk
Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1
|
Treatment 4
n=25 participants at risk
Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1
|
Treatment 5
n=25 participants at risk
Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1
|
|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
8.0%
2/25 • Number of events 2 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
|
Nervous system disorders
Headache
|
8.0%
2/25 • Number of events 2 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
8.0%
2/25 • Number of events 2 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
12.0%
3/25 • Number of events 3 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
|
Eye disorders
Eye pain
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
|
Eye disorders
Swelling of eyelid
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
|
Gastrointestinal disorders
Flatulence
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
4.0%
1/25 • Number of events 2 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
|
General disorders
Fatigue
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
|
General disorders
Feeling hot
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
4.0%
1/25 • Number of events 1 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
0.00%
0/25 • From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical study Information Center
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No unpublished information contained herein may be disclosed without prior written approval from AstraZeneca AB. Access to this document must be restricted to relevant parties.
- Publication restrictions are in place
Restriction type: OTHER