Trial Outcomes & Findings for Pharmacokinetics of Verinurad and Allopurinol in Combination With Cyclosporine and Rifampicin in Healthy Volunteers (NCT NCT04532918)
NCT ID: NCT04532918
Last Updated: 2023-03-27
Results Overview
Evaluation of a single dose of cyclosporine or rifampicin on the PK of verinurad. Verinurad Cmax ratio of geometric mean of test treatment (verinurad+allopurinol with \[cyclosporine or rifampicin\], relative to reference treatment (verinurad+allopurinol alone) in each treatment period.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Days 1 to 5 (pre-dose and post-dose)
Results posted on
2023-03-27
Participant Flow
The study was conducted between 10-Sep-2020 and 23-Nov-2020 in Germany.
Participants who met the inclusion and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment.
Participant milestones
| Measure |
Overall Study
Participants received treatments in 3 different treatment periods. Single oral dose of extended release capsule verinurad 7.5 mg, and tablet allopurinol 300 mg, in all 3 treatment periods, under fasted conditions. Along with, participants also received single oral dose of soft capsule of cyclosporine 600 mg in treatment period 2, and film coated tablets of rifampicin 600 mg in treatment period 3 respectively, under fasted condition. There was a washout period of 14 days between treatment periods 2 and 3 dosing.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Verinurad and Allopurinol in Combination With Cyclosporine and Rifampicin in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Overall Study
n=14 Participants
Participants received treatments in 3 different treatment periods. Single oral dose of extended release capsule verinurad 7.5 mg, and tablet allopurinol 300 mg, in all 3 treatment periods, under fasted conditions. Along with, participants also received single oral dose of soft capsule of cyclosporine 600 mg in treatment period 2, and film coated tablets of rifampicin 600 mg in treatment period 3 respectively, under fasted condition. There was a washout period of 14 days between treatment periods 2 and 3 dosing.
|
|---|---|
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Age, Continuous
|
34.6 Years
STANDARD_DEVIATION 12.6 • n=39 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The pharmacokinetic (PK) analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
Evaluation of a single dose of cyclosporine or rifampicin on the PK of verinurad. Verinurad Cmax ratio of geometric mean of test treatment (verinurad+allopurinol with \[cyclosporine or rifampicin\], relative to reference treatment (verinurad+allopurinol alone) in each treatment period.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
Geometric Mean Ratio of Maximum Observed Plasma Peak Concentration (Cmax) for Verinurad
|
13.30 ng/mL
Geometric Coefficient of Variation 53.48
|
33.96 ng/mL
Geometric Coefficient of Variation 29.39
|
26.09 ng/mL
Geometric Coefficient of Variation 32.28
|
PRIMARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The PK analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
Evaluation of a single dose of cyclosporine or rifampicin on the PK of verinurad. Verinurad AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
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Geometric Mean Ratio of Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) for Verinurad
|
90.25 h*ng/mL
Geometric Coefficient of Variation 50.76
|
215.1 h*ng/mL
Geometric Coefficient of Variation 30.94
|
138.0 h*ng/mL
Geometric Coefficient of Variation 26.11
|
PRIMARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The PK analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
Evaluation of a single dose of cyclosporine or rifampicin on the PK of verinurad. Verinurad AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
Geometric Mean Ratio of Area Under the Plasma Concentration-time Curve From Zero to Time of Last Quantifiable Concentration (AUClast) for Verinurad
|
79.67 h*ng/mL
Geometric Coefficient of Variation 50.43
|
208.6 h*ng/mL
Geometric Coefficient of Variation 30.07
|
133.4 h*ng/mL
Geometric Coefficient of Variation 26.59
|
SECONDARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The PK analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
Evaluation of a single dose of cyclosporine or rifampicin on the PK of verinurad metabolites M1 and M8. Cmax ratio of geometric means of test treatment, relative to reference treatment in each treatment period.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
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Geometric Mean Ratio of Cmax for Verinurad Metabolites: M1 and M8
M1
|
17.24 ng/mL
Geometric Coefficient of Variation 50.28
|
47.14 ng/mL
Geometric Coefficient of Variation 34.05
|
48.70 ng/mL
Geometric Coefficient of Variation 31.47
|
|
Geometric Mean Ratio of Cmax for Verinurad Metabolites: M1 and M8
M8
|
15.57 ng/mL
Geometric Coefficient of Variation 40.02
|
3.839 ng/mL
Geometric Coefficient of Variation 59.94
|
6.002 ng/mL
Geometric Coefficient of Variation 48.53
|
SECONDARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The PK analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
Evaluation of a single dose of cyclosporine or rifampicin on the PK of verinurad metabolites M1 and M8. AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
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Geometric Mean Ratio of AUCinf for Verinurad Metabolites: M1 and M8
M1
|
119.5 h*ng/mL
Geometric Coefficient of Variation 50.57
|
348.7 h*ng/mL
Geometric Coefficient of Variation 39.87
|
264.9 h*ng/mL
Geometric Coefficient of Variation 30.04
|
|
Geometric Mean Ratio of AUCinf for Verinurad Metabolites: M1 and M8
M8
|
110.3 h*ng/mL
Geometric Coefficient of Variation 46.28
|
60.98 h*ng/mL
Geometric Coefficient of Variation 60.46
|
77.35 h*ng/mL
Geometric Coefficient of Variation 43.24
|
SECONDARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The PK analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
Evaluation of a single dose of cyclosporine or rifampicin on the PK of verinurad metabolites M1 and M8. AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period is reported.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
Geometric Mean Ratio of AUClast for Verinurad Metabolites: M1 and M8
M1
|
111.6 h*ng/mL
Geometric Coefficient of Variation 51.84
|
341.9 h*ng/mL
Geometric Coefficient of Variation 40.12
|
260.6 h*ng/mL
Geometric Coefficient of Variation 30.70
|
|
Geometric Mean Ratio of AUClast for Verinurad Metabolites: M1 and M8
M8
|
101.8 h*ng/mL
Geometric Coefficient of Variation 45.17
|
51.95 h*ng/mL
Geometric Coefficient of Variation 52.12
|
73.23 h*ng/mL
Geometric Coefficient of Variation 44.42
|
SECONDARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The PK analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
Evaluation of a single dose of cyclosporine or rifampicin on the PK of allopurinol and oxypurinol. Cmax ratio of geometric means of test geometric means of test treatment, relative to reference treatment in each treatment period is reported.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
Geometric Mean Ratio of Cmax for Allopurinol and Oxypurinol
Allopurinol
|
1947 ng/mL
Geometric Coefficient of Variation 51.09
|
1457 ng/mL
Geometric Coefficient of Variation 33.20
|
1597 ng/mL
Geometric Coefficient of Variation 38.55
|
|
Geometric Mean Ratio of Cmax for Allopurinol and Oxypurinol
Oxypurinol
|
6064 ng/mL
Geometric Coefficient of Variation 18.15
|
5876 ng/mL
Geometric Coefficient of Variation 18.24
|
6051 ng/mL
Geometric Coefficient of Variation 20.41
|
SECONDARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The PK analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
Evaluation of a single dose of cyclosporine or rifampicin on the PK of allopurinol and oxypurinol. AUCinf ratio of geometric means of test geometric means of test treatment, relative to reference treatment in each treatment period is reported.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
Geometric Mean Ratio of AUCinf for Allopurinol and Oxypurinol
Allopurinol
|
3982 h*ng/mL
Geometric Coefficient of Variation 22.69
|
3914 h*ng/mL
Geometric Coefficient of Variation 20.06
|
4163 h*ng/mL
Geometric Coefficient of Variation 19.24
|
|
Geometric Mean Ratio of AUCinf for Allopurinol and Oxypurinol
Oxypurinol
|
196500 h*ng/mL
Geometric Coefficient of Variation 28.48
|
181900 h*ng/mL
Geometric Coefficient of Variation 24.23
|
195500 h*ng/mL
Geometric Coefficient of Variation 24.85
|
SECONDARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The PK analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
Evaluation of a single dose of cyclosporine or rifampicin on the PK of allopurinol and oxypurinol. AUClast ratio of geometric means of test geometric means of test treatment, relative to reference treatment in each treatment period is reported.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
Geometric Mean Ratio of AUClast for Allopurinol and Oxypurinol
Allopurinol
|
3889 h*ng/mL
Geometric Coefficient of Variation 23.01
|
3821 h*ng/mL
Geometric Coefficient of Variation 19.78
|
4080 h*ng/mL
Geometric Coefficient of Variation 19.24
|
|
Geometric Mean Ratio of AUClast for Allopurinol and Oxypurinol
Oxypurinol
|
183600 h*ng/mL
Geometric Coefficient of Variation 24.64
|
170600 h*ng/mL
Geometric Coefficient of Variation 22.29
|
182100 h*ng/mL
Geometric Coefficient of Variation 21.72
|
SECONDARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The PK analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
AUC(0-24) of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
Area Under Plasma Concentration-time Curve From Zero to 24 Hours Post-dose AUC(0-24) of Verinurad, M1, M8, Allopurinol and Oxypurinol
Verinurad
|
62.02 h*ng/mL
Geometric Coefficient of Variation 45.44
|
192.2 h*ng/mL
Geometric Coefficient of Variation 31.45
|
118.4 h*ng/mL
Geometric Coefficient of Variation 23.88
|
|
Area Under Plasma Concentration-time Curve From Zero to 24 Hours Post-dose AUC(0-24) of Verinurad, M1, M8, Allopurinol and Oxypurinol
M1
|
86.23 h*ng/mL
Geometric Coefficient of Variation 45.69
|
314.4 h*ng/mL
Geometric Coefficient of Variation 39.75
|
242.9 h*ng/mL
Geometric Coefficient of Variation 29.33
|
|
Area Under Plasma Concentration-time Curve From Zero to 24 Hours Post-dose AUC(0-24) of Verinurad, M1, M8, Allopurinol and Oxypurinol
M8
|
79.80 h*ng/mL
Geometric Coefficient of Variation 41.26
|
38.02 h*ng/mL
Geometric Coefficient of Variation 45.54
|
48.81 h*ng/mL
Geometric Coefficient of Variation 45.08
|
|
Area Under Plasma Concentration-time Curve From Zero to 24 Hours Post-dose AUC(0-24) of Verinurad, M1, M8, Allopurinol and Oxypurinol
Allopurinol
|
3982 h*ng/mL
Geometric Coefficient of Variation 22.69
|
3914 h*ng/mL
Geometric Coefficient of Variation 20.05
|
4163 h*ng/mL
Geometric Coefficient of Variation 19.24
|
|
Area Under Plasma Concentration-time Curve From Zero to 24 Hours Post-dose AUC(0-24) of Verinurad, M1, M8, Allopurinol and Oxypurinol
Oxypurinol
|
100700 h*ng/mL
Geometric Coefficient of Variation 17.92
|
95080 h*ng/mL
Geometric Coefficient of Variation 18.15
|
98460 h*ng/mL
Geometric Coefficient of Variation 18.59
|
SECONDARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The PK analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
tmax of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
Time to Reach Peak or Maximum Plasma Concentration (Tmax) for Verinurad, M1, M8, Allopurinol and Oxypurinol
Verinurad
|
4.03 Hours
Interval 3.0 to 8.0
|
5.00 Hours
Interval 2.98 to 6.02
|
4.00 Hours
Interval 3.0 to 6.0
|
|
Time to Reach Peak or Maximum Plasma Concentration (Tmax) for Verinurad, M1, M8, Allopurinol and Oxypurinol
M1
|
4.02 Hours
Interval 3.0 to 10.0
|
5.98 Hours
Interval 4.02 to 10.03
|
4.00 Hours
Interval 4.0 to 6.02
|
|
Time to Reach Peak or Maximum Plasma Concentration (Tmax) for Verinurad, M1, M8, Allopurinol and Oxypurinol
M8
|
4.52 Hours
Interval 4.0 to 8.0
|
8.00 Hours
Interval 5.0 to 12.0
|
5.00 Hours
Interval 4.0 to 7.98
|
|
Time to Reach Peak or Maximum Plasma Concentration (Tmax) for Verinurad, M1, M8, Allopurinol and Oxypurinol
Allopurinol
|
0.50 Hours
Interval 0.5 to 2.02
|
1.00 Hours
Interval 0.5 to 2.0
|
1.00 Hours
Interval 0.5 to 3.0
|
|
Time to Reach Peak or Maximum Plasma Concentration (Tmax) for Verinurad, M1, M8, Allopurinol and Oxypurinol
Oxypurinol
|
4.00 Hours
Interval 0.5 to 6.03
|
4.00 Hours
Interval 0.5 to 5.0
|
3.00 Hours
Interval 0.5 to 5.02
|
SECONDARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The PK analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
t½λz of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration Time Curve (t½λz) of Verinurad, M1, M8, Allopurinol and Oxypurinol
Verinurad
|
20.31 Hours
Standard Deviation 12.02
|
14.73 Hours
Standard Deviation 13.00
|
15.03 Hours
Standard Deviation 12.54
|
|
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration Time Curve (t½λz) of Verinurad, M1, M8, Allopurinol and Oxypurinol
M1
|
18.04 Hours
Standard Deviation 10.81
|
13.05 Hours
Standard Deviation 9.455
|
12.52 Hours
Standard Deviation 7.010
|
|
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration Time Curve (t½λz) of Verinurad, M1, M8, Allopurinol and Oxypurinol
M8
|
18.25 Hours
Standard Deviation 8.326
|
21.90 Hours
Standard Deviation 24.13
|
14.89 Hours
Standard Deviation 6.948
|
|
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration Time Curve (t½λz) of Verinurad, M1, M8, Allopurinol and Oxypurinol
Allopurinol
|
1.210 Hours
Standard Deviation 0.1427
|
1.261 Hours
Standard Deviation 0.2790
|
1.170 Hours
Standard Deviation 0.1052
|
|
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration Time Curve (t½λz) of Verinurad, M1, M8, Allopurinol and Oxypurinol
Oxypurinol
|
23.19 Hours
Standard Deviation 6.361
|
22.36 Hours
Standard Deviation 4.977
|
23.76 Hours
Standard Deviation 5.641
|
SECONDARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The PK analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
λz of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
Terminal Elimination Rate Constant (λz) of Verinurad, M1, M8, Allopurinol and Oxypurinol
Verinurad
|
0.03842 1/Hours
Geometric Coefficient of Variation 49.71
|
0.06101 1/Hours
Geometric Coefficient of Variation 82.31
|
0.05557 1/Hours
Geometric Coefficient of Variation 62.04
|
|
Terminal Elimination Rate Constant (λz) of Verinurad, M1, M8, Allopurinol and Oxypurinol
M1
|
0.04293 1/Hours
Geometric Coefficient of Variation 47.35
|
0.06518 1/Hours
Geometric Coefficient of Variation 71.96
|
0.06417 1/Hours
Geometric Coefficient of Variation 61.89
|
|
Terminal Elimination Rate Constant (λz) of Verinurad, M1, M8, Allopurinol and Oxypurinol
M8
|
0.04163 1/Hours
Geometric Coefficient of Variation 46.83
|
0.04497 1/Hours
Geometric Coefficient of Variation 93.89
|
0.05133 1/Hours
Geometric Coefficient of Variation 48.74
|
|
Terminal Elimination Rate Constant (λz) of Verinurad, M1, M8, Allopurinol and Oxypurinol
Allopurinol
|
0.5770 1/Hours
Geometric Coefficient of Variation 12.51
|
0.5616 1/Hours
Geometric Coefficient of Variation 21.69
|
0.5950 1/Hours
Geometric Coefficient of Variation 9.540
|
|
Terminal Elimination Rate Constant (λz) of Verinurad, M1, M8, Allopurinol and Oxypurinol
Oxypurinol
|
0.03086 1/Hours
Geometric Coefficient of Variation 26.32
|
0.03169 1/Hours
Geometric Coefficient of Variation 22.14
|
0.02990 1/Hours
Geometric Coefficient of Variation 23.34
|
SECONDARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The PK analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
CL/F for verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F) for Verinurad and Allopurinol
Verinurad
|
92.30 Liter/Hours
Standard Deviation 43.40
|
36.32 Liter/Hours
Standard Deviation 10.44
|
55.99 Liter/Hours
Standard Deviation 14.00
|
|
Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F) for Verinurad and Allopurinol
Allopurinol
|
77.12 Liter/Hours
Standard Deviation 17.51
|
78.09 Liter/Hours
Standard Deviation 16.07
|
73.29 Liter/Hours
Standard Deviation 14.24
|
SECONDARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The PK analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
MRTinf for verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
Mean Residence Time of the Unchanged Drug in the Systemic Circulation (MRTinf) for Verinurad and Allopurinol
Verinurad
|
21.28 Hours
Geometric Coefficient of Variation 49.56
|
11.05 Hours
Geometric Coefficient of Variation 50.07
|
12.60 Hours
Geometric Coefficient of Variation 36.82
|
|
Mean Residence Time of the Unchanged Drug in the Systemic Circulation (MRTinf) for Verinurad and Allopurinol
Allopurinol
|
2.316 Hours
Geometric Coefficient of Variation 30.10
|
2.713 Hours
Geometric Coefficient of Variation 22.05
|
2.496 Hours
Geometric Coefficient of Variation 20.04
|
SECONDARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The PK analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
Vss/F of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vss/F) of Verinurad and Allopurinol
Verinurad
|
1768 Liters
Geometric Coefficient of Variation 53.52
|
385.2 Liters
Geometric Coefficient of Variation 52.45
|
685.0 Liters
Geometric Coefficient of Variation 38.16
|
|
Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vss/F) of Verinurad and Allopurinol
Allopurinol
|
174.5 Liters
Geometric Coefficient of Variation 41.88
|
208.0 Liters
Geometric Coefficient of Variation 17.39
|
179.9 Liters
Geometric Coefficient of Variation 30.55
|
SECONDARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The PK analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
Vz/F of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Based on the Terminal Phase) (Vz/F) of Verinurad and Allopurinol
Verinurad
|
2455 Liters
Standard Deviation 1337
|
721.8 Liters
Standard Deviation 574.6
|
1153 Liters
Standard Deviation 758.7
|
|
Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Based on the Terminal Phase) (Vz/F) of Verinurad and Allopurinol
Allopurinol
|
133.5 Liters
Standard Deviation 27.94
|
137.9 Liters
Standard Deviation 20.16
|
122.6 Liters
Standard Deviation 18.84
|
SECONDARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The PK analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
Metabolite:parent (MP) Cmax ratios for M1 and M8: verinurad when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
Metabolite:Parent (MP) Cmax Ratios for M1 and M8: Verinurad
M1: verinurad
|
1.296 Ratio
Geometric Coefficient of Variation 36.79
|
1.388 Ratio
Geometric Coefficient of Variation 28.01
|
1.866 Ratio
Geometric Coefficient of Variation 24.09
|
|
Metabolite:Parent (MP) Cmax Ratios for M1 and M8: Verinurad
M8: verinurad
|
1.171 Ratio
Geometric Coefficient of Variation 30.12
|
0.1130 Ratio
Geometric Coefficient of Variation 56.62
|
0.2300 Ratio
Geometric Coefficient of Variation 52.89
|
SECONDARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The PK analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
Metabolite:parent (MP) AUCinf ratios for M1 and M8: verinurad when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
Metabolite:Parent (MP) AUCinf Ratios for M1 and M8: Verinurad
M1:verinurad
|
1.324 Ratio
Geometric Coefficient of Variation 35.14
|
1.621 Ratio
Geometric Coefficient of Variation 23.80
|
1.919 Ratio
Geometric Coefficient of Variation 22.89
|
|
Metabolite:Parent (MP) AUCinf Ratios for M1 and M8: Verinurad
M8:verinurad
|
1.222 Ratio
Geometric Coefficient of Variation 27.85
|
0.2834 Ratio
Geometric Coefficient of Variation 56.73
|
0.5604 Ratio
Geometric Coefficient of Variation 36.82
|
SECONDARY outcome
Timeframe: Days 1 to 5 (pre-dose and post-dose)Population: The PK analysis set included all participants in the safety analysis set who received a verinurad+allopurinol dose and who had at least 1 quantifiable post-dose plasma concentration.
Metabolite:parent (MP) AUClast ratios for M1 and M8: verinurad when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period.
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
Metabolite:Parent (MP) AUClast Ratios for M1 and M8: Verinurad
M1:verinurad
|
1.400 Ratio
Geometric Coefficient of Variation 28.68
|
1.639 Ratio
Geometric Coefficient of Variation 24.98
|
1.955 Ratio
Geometric Coefficient of Variation 23.27
|
|
Metabolite:Parent (MP) AUClast Ratios for M1 and M8: Verinurad
M8:verinurad
|
1.278 Ratio
Geometric Coefficient of Variation 26.07
|
0.2491 Ratio
Geometric Coefficient of Variation 54.22
|
0.5491 Ratio
Geometric Coefficient of Variation 39.93
|
SECONDARY outcome
Timeframe: From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)Population: The safety analysis set included all participants who received at least 1 dose of study drug, and for whom safety post-dose data were available, were included in the safety analysis for the study.
Assessment the safety and tolerability of verinurad and allopurinol in combination with cyclosporine or rifampicin
Outcome measures
| Measure |
Period 1: Verinurad + Allopurinol
n=14 Participants
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 Participants
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Any AE
|
2 Participants
|
10 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Any AE with outcome = death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Any SAE
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Any AE leading to discontinuation of study drug
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Any AE leading to withdrawal from study
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Period 1: Verinurad + Allopurinol
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Period 2: Verinurad + Allopurinol + Cyclosporine
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Period 3: Verinurad + Allopurinol + Rifampicin
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1: Verinurad + Allopurinol
n=14 participants at risk
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 participants at risk
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 participants at risk
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/14 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
0.00%
0/14 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
7.7%
1/13 • Number of events 1 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/14 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
0.00%
0/14 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
7.7%
1/13 • Number of events 1 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
Other adverse events
| Measure |
Period 1: Verinurad + Allopurinol
n=14 participants at risk
Participants received a single oral dose extended release capsule of verinurad 7.5 mg, and tablet of allopurinol 300 mg, under fasted conditions from days 1 to 5.
|
Period 2: Verinurad + Allopurinol + Cyclosporine
n=14 participants at risk
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and soft capsule cyclosporine 600 mg, under fasted conditions from days 1 to 5.
|
Period 3: Verinurad + Allopurinol + Rifampicin
n=13 participants at risk
Participants received a single oral dose extended release capsule verinurad 7.5 mg, tablet allopurinol 300 mg, and film coated tablets rifampicin, under fasted conditions from days 1 to 5.
|
|---|---|---|---|
|
General disorders
Feeling hot
|
0.00%
0/14 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
57.1%
8/14 • Number of events 8 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
0.00%
0/13 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
|
General disorders
Fatigue
|
0.00%
0/14 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
14.3%
2/14 • Number of events 2 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
0.00%
0/13 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/14 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
7.1%
1/14 • Number of events 1 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
0.00%
0/13 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/14 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
14.3%
2/14 • Number of events 2 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
0.00%
0/13 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
7.1%
1/14 • Number of events 1 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
0.00%
0/13 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
14.3%
2/14 • Number of events 2 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
0.00%
0/13 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/14 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
7.1%
1/14 • Number of events 1 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
0.00%
0/13 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
7.1%
1/14 • Number of events 1 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
0.00%
0/13 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
7.1%
1/14 • Number of events 1 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
0.00%
0/13 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
1/14 • Number of events 1 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
0.00%
0/14 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
0.00%
0/13 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
7.1%
1/14 • Number of events 1 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
0.00%
0/13 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/14 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
0.00%
0/14 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
15.4%
2/13 • Number of events 2 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/14 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
7.1%
1/14 • Number of events 1 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
0.00%
0/13 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
7.1%
1/14 • Number of events 1 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
0.00%
0/13 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14 • Number of events 1 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
7.1%
1/14 • Number of events 1 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
0.00%
0/13 • From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
|
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
- Publication restrictions are in place
Restriction type: OTHER