Trial Outcomes & Findings for Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects (NCT NCT02498652)
NCT ID: NCT02498652
Last Updated: 2018-01-23
Results Overview
Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Results posted on
2018-01-23
Participant Flow
41 subjects were randomized.
Forty-one subjects were randomized and received at least 1 dose of randomized study medication; 20 subjects in Cohort 1 and 21 subjects in Cohort 2. Subjects were randomized into 1 of 8 sequences across the 2 cohorts (20 subjects each) in a 1:1 ratio.A total of 40 subjects completed the study.
Participant milestones
| Measure |
Cohort 1
Allopurinol 300 mg once daily (qd), 600 mg qd, RDEA3170 2.5 mg qd, 15 mg qd and 7.5 mg qd
|
Cohort 2
Allopurinol 300 mg qd, 600 mg (300 mg bid), RDEA3170 5 mg qd, 20 mg qd and 10 mg qd
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1
Allopurinol 300 mg once daily (qd), 600 mg qd, RDEA3170 2.5 mg qd, 15 mg qd and 7.5 mg qd
|
Cohort 2
Allopurinol 300 mg qd, 600 mg (300 mg bid), RDEA3170 5 mg qd, 20 mg qd and 10 mg qd
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects
Baseline characteristics by cohort
| Measure |
Cohort 1
n=20 Participants
Allopurinol 300 mg once daily (qd), 600 mg qd, RDEA3170 2.5 mg qd, 15 mg qd and 7.5 mg qd
|
Cohort 2
n=21 Participants
Allopurinol 300 mg qd, 600 mg (300 mg bid), RDEA3170 5 mg qd, 20 mg qd and 10 mg qd
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 Years
STANDARD_DEVIATION 12.7 • n=99 Participants
|
48 Years
STANDARD_DEVIATION 10.9 • n=107 Participants
|
49 Years
STANDARD_DEVIATION 11.7 • n=206 Participants
|
|
Sex/Gender, Customized
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
19 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
Outcome measures
| Measure |
Treatment A1
n=20 Participants
Allopurinol 300 mg qd
|
Treatment A2q
n=10 Participants
Allopurinol 600 mg qd
|
Treatment A2b
n=10 Participants
Allopurinol 600 mg (300 mg bid)
|
Treatment R1
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
|
Treatment R3
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
|
Treatment R5
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 15 mg qd
|
Treatment R4
Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
|
Treatment R5
Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
|
Treatment R6
Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))
|
-40.2 Maximum Percentage (%) Change
Standard Error 3.29
|
-55.0 Maximum Percentage (%) Change
Standard Error 4.96
|
-56.8 Maximum Percentage (%) Change
Standard Error 4.52
|
-48.1 Maximum Percentage (%) Change
Standard Error 2.91
|
-61.0 Maximum Percentage (%) Change
Standard Error 2.59
|
-69.5 Maximum Percentage (%) Change
Standard Error 2.09
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
Outcome measures
| Measure |
Treatment A1
n=20 Participants
Allopurinol 300 mg qd
|
Treatment A2q
n=10 Participants
Allopurinol 600 mg qd
|
Treatment A2b
n=10 Participants
Allopurinol 600 mg (300 mg bid)
|
Treatment R1
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
|
Treatment R3
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
|
Treatment R5
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 15 mg qd
|
Treatment R4
Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
|
Treatment R5
Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
|
Treatment R6
Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.
|
5.8 mg/dL
Standard Error 0.24
|
4.8 mg/dL
Standard Error 0.38
|
4.0 mg/dL
Standard Error 0.39
|
5.5 mg/dL
Standard Error 0.24
|
4.6 mg/dL
Standard Error 0.22
|
3.8 mg/dL
Standard Error 0.18
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
Outcome measures
| Measure |
Treatment A1
n=20 Participants
Allopurinol 300 mg qd
|
Treatment A2q
n=10 Participants
Allopurinol 600 mg qd
|
Treatment A2b
n=10 Participants
Allopurinol 600 mg (300 mg bid)
|
Treatment R1
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
|
Treatment R3
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
|
Treatment R5
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 15 mg qd
|
Treatment R4
Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
|
Treatment R5
Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
|
Treatment R6
Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))
|
1065 Percentage (%) Change
Standard Error 138
|
1827 Percentage (%) Change
Standard Error 252
|
2633 Percentage (%) Change
Standard Error 255
|
899 Percentage (%) Change
Standard Error 116
|
958 Percentage (%) Change
Standard Error 128
|
827 Percentage (%) Change
Standard Error 106
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
Outcome measures
| Measure |
Treatment A1
n=20 Participants
Allopurinol 300 mg qd
|
Treatment A2q
n=10 Participants
Allopurinol 600 mg qd
|
Treatment A2b
n=10 Participants
Allopurinol 600 mg (300 mg bid)
|
Treatment R1
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
|
Treatment R3
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
|
Treatment R5
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 15 mg qd
|
Treatment R4
Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
|
Treatment R5
Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
|
Treatment R6
Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))
|
400 Percentage (%) Change
Standard Error 74.6
|
517 Percentage (%) Change
Standard Error 106
|
827 Percentage (%) Change
Standard Error 136
|
310 Percentage (%) Change
Standard Error 55.5
|
311 Percentage (%) Change
Standard Error 51.8
|
305 Percentage (%) Change
Standard Error 54.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)
Outcome measures
| Measure |
Treatment A1
n=20 Participants
Allopurinol 300 mg qd
|
Treatment A2q
n=10 Participants
Allopurinol 600 mg qd
|
Treatment A2b
n=10 Participants
Allopurinol 600 mg (300 mg bid)
|
Treatment R1
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
|
Treatment R3
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
|
Treatment R5
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 15 mg qd
|
Treatment R4
Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
|
Treatment R5
Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
|
Treatment R6
Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))
|
-39.3 Maximum Percentage (%) Change
Standard Error 1.78
|
-54.4 Maximum Percentage (%) Change
Standard Error 4.50
|
-50.3 Maximum Percentage (%) Change
Standard Error 4.15
|
-57.8 Maximum Percentage (%) Change
Standard Error 1.61
|
-66.0 Maximum Percentage (%) Change
Standard Error 1.86
|
-73.2 Maximum Percentage (%) Change
Standard Error 1.75
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)
Outcome measures
| Measure |
Treatment A1
n=20 Participants
Allopurinol 300 mg qd
|
Treatment A2q
n=10 Participants
Allopurinol 600 mg qd
|
Treatment A2b
n=10 Participants
Allopurinol 600 mg (300 mg bid)
|
Treatment R1
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
|
Treatment R3
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
|
Treatment R5
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 15 mg qd
|
Treatment R4
Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
|
Treatment R5
Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
|
Treatment R6
Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.
|
6.2 mg/dL
Standard Error 0.22
|
5.0 mg/dL
Standard Error 0.61
|
4.6 mg/dL
Standard Error 0.33
|
4.8 mg/dL
Standard Error 0.22
|
4.1 mg/dL
Standard Error 0.22
|
3.5 mg/dL
Standard Error 0.20
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)
Outcome measures
| Measure |
Treatment A1
n=20 Participants
Allopurinol 300 mg qd
|
Treatment A2q
n=10 Participants
Allopurinol 600 mg qd
|
Treatment A2b
n=10 Participants
Allopurinol 600 mg (300 mg bid)
|
Treatment R1
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
|
Treatment R3
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
|
Treatment R5
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 15 mg qd
|
Treatment R4
Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
|
Treatment R5
Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
|
Treatment R6
Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))
|
952 Percentage (%) Change
Standard Error 77.2
|
2027 Percentage (%) Change
Standard Error 203
|
2138 Percentage (%) Change
Standard Error 164
|
812 Percentage (%) Change
Standard Error 76.3
|
797 Percentage (%) Change
Standard Error 65.7
|
816 Percentage (%) Change
Standard Error 71.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)
Outcome measures
| Measure |
Treatment A1
n=20 Participants
Allopurinol 300 mg qd
|
Treatment A2q
n=10 Participants
Allopurinol 600 mg qd
|
Treatment A2b
n=10 Participants
Allopurinol 600 mg (300 mg bid)
|
Treatment R1
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
|
Treatment R3
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
|
Treatment R5
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 15 mg qd
|
Treatment R4
Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
|
Treatment R5
Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
|
Treatment R6
Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))
|
372 Percentage (%) Change
Standard Error 33.9
|
645 Percentage (%) Change
Standard Error 76.9
|
681 Percentage (%) Change
Standard Error 63.9
|
268 Percentage (%) Change
Standard Error 24.1
|
267 Percentage (%) Change
Standard Error 23.4
|
286 Percentage (%) Change
Standard Error 25.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)Cmax of Allopurinol alone or in combination with RDEA3170
Outcome measures
| Measure |
Treatment A1
n=40 Participants
Allopurinol 300 mg qd
|
Treatment A2q
n=20 Participants
Allopurinol 600 mg qd
|
Treatment A2b
n=20 Participants
Allopurinol 600 mg (300 mg bid)
|
Treatment R1
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
|
Treatment R3
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
|
Treatment R5
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 15 mg qd
|
Treatment R4
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
|
Treatment R5
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
|
Treatment R6
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax)
|
1.18 µg/mL
Interval 1.03 to 1.36
|
2.43 µg/mL
Interval 1.94 to 3.04
|
1.19 µg/mL
Interval 0.997 to 1.42
|
1.16 µg/mL
Interval 0.911 to 1.47
|
1.16 µg/mL
Interval 0.937 to 1.43
|
1.14 µg/mL
Interval 0.905 to 1.44
|
1.11 µg/mL
Interval 0.928 to 1.33
|
1.12 µg/mL
Interval 0.877 to 1.44
|
1.26 µg/mL
Interval 1.02 to 1.56
|
SECONDARY outcome
Timeframe: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)Tmax of Allopurinol alone or in combination with RDEA3170
Outcome measures
| Measure |
Treatment A1
n=40 Participants
Allopurinol 300 mg qd
|
Treatment A2q
n=20 Participants
Allopurinol 600 mg qd
|
Treatment A2b
n=20 Participants
Allopurinol 600 mg (300 mg bid)
|
Treatment R1
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
|
Treatment R3
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
|
Treatment R5
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 15 mg qd
|
Treatment R4
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
|
Treatment R5
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
|
Treatment R6
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Time of Occurrence of Maximum Observed Concentration (Tmax)
|
1.50 hr
Interval 0.5 to 6.02
|
2.98 hr
Interval 0.983 to 4.0
|
2.02 hr
Interval 0.5 to 8.0
|
2.01 hr
Interval 0.967 to 6.0
|
2.49 hr
Interval 0.5 to 3.97
|
1.73 hr
Interval 0.5 to 6.0
|
2.98 hr
Interval 0.5 to 6.02
|
1.73 hr
Interval 0.5 to 6.0
|
1.97 hr
Interval 0.5 to 4.03
|
SECONDARY outcome
Timeframe: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)AUC 0-24 of Allopurinol alone or in combination with RDEA3170
Outcome measures
| Measure |
Treatment A1
n=40 Participants
Allopurinol 300 mg qd
|
Treatment A2q
n=20 Participants
Allopurinol 600 mg qd
|
Treatment A2b
n=20 Participants
Allopurinol 600 mg (300 mg bid)
|
Treatment R1
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
|
Treatment R3
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
|
Treatment R5
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 15 mg qd
|
Treatment R4
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
|
Treatment R5
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
|
Treatment R6
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
|
3.94 µg·hr/mL
Interval 3.52 to 4.42
|
11.0 µg·hr/mL
Interval 8.87 to 13.7
|
8.64 µg·hr/mL
Interval 7.13 to 10.5
|
4.06 µg·hr/mL
Interval 3.24 to 5.1
|
4.10 µg·hr/mL
Interval 3.53 to 4.77
|
3.81 µg·hr/mL
Interval 3.13 to 4.64
|
3.83 µg·hr/mL
Interval 3.15 to 4.65
|
3.88 µg·hr/mL
Interval 3.15 to 4.77
|
3.82 µg·hr/mL
Interval 3.27 to 4.46
|
SECONDARY outcome
Timeframe: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)AUC last of Allopurinol alone or in combination with RDEA3170
Outcome measures
| Measure |
Treatment A1
n=40 Participants
Allopurinol 300 mg qd
|
Treatment A2q
n=20 Participants
Allopurinol 600 mg qd
|
Treatment A2b
n=20 Participants
Allopurinol 600 mg (300 mg bid)
|
Treatment R1
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
|
Treatment R3
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
|
Treatment R5
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 15 mg qd
|
Treatment R4
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
|
Treatment R5
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
|
Treatment R6
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
|
3.70 µg·hr/mL
Interval 3.28 to 4.18
|
10.9 µg·hr/mL
Interval 8.74 to 13.5
|
4.25 µg·hr/mL
Interval 3.57 to 5.07
|
3.59 µg·hr/mL
Interval 2.87 to 4.49
|
3.76 µg·hr/mL
Interval 3.2 to 4.41
|
3.71 µg·hr/mL
Interval 3.04 to 4.54
|
3.53 µg·hr/mL
Interval 2.84 to 4.39
|
3.74 µg·hr/mL
Interval 3.21 to 4.34
|
3.74 µg·hr/mL
Interval 3.21 to 4.34
|
SECONDARY outcome
Timeframe: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)t1/2 of Allopurinol alone or in combination with RDEA3170
Outcome measures
| Measure |
Treatment A1
n=40 Participants
Allopurinol 300 mg qd
|
Treatment A2q
n=20 Participants
Allopurinol 600 mg qd
|
Treatment A2b
n=20 Participants
Allopurinol 600 mg (300 mg bid)
|
Treatment R1
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
|
Treatment R3
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
|
Treatment R5
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 15 mg qd
|
Treatment R4
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
|
Treatment R5
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
|
Treatment R6
n=20 Participants
Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2)
|
1.21 hr
Interval 1.14 to 1.27
|
1.47 hr
Interval 1.33 to 1.62
|
1.25 hr
Interval 1.13 to 1.38
|
1.20 hr
Interval 1.1 to 1.3
|
1.14 hr
Interval 1.03 to 1.25
|
1.17 hr
Interval 1.1 to 1.25
|
1.16 hr
Interval 1.08 to 1.24
|
1.13 hr
Interval 1.04 to 1.22
|
1.13 hr
Interval 1.03 to 1.24
|
SECONDARY outcome
Timeframe: 11 weeksOutcome measures
| Measure |
Treatment A1
n=20 Participants
Allopurinol 300 mg qd
|
Treatment A2q
n=21 Participants
Allopurinol 600 mg qd
|
Treatment A2b
Allopurinol 600 mg (300 mg bid)
|
Treatment R1
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
|
Treatment R3
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
|
Treatment R5
Allopurinol 300 mg qd + RDEA3170 15 mg qd
|
Treatment R4
Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
|
Treatment R5
Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
|
Treatment R6
Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
|
6 Number of participants
|
6 Number of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=20 participants at risk
RDEA3170 2.5 mg, 7.5 mg and 15 mg qd in combination with allopurinol 300 mg (qd and bid)
|
Cohort 2
n=21 participants at risk
RDEA3170 5 mg, 10 mg 20 mg qd in combination with allopurinol 300 mg (qd and bid)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
5.0%
1/20 • Number of events 1 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
0.00%
0/21 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
Other adverse events
| Measure |
Cohort 1
n=20 participants at risk
RDEA3170 2.5 mg, 7.5 mg and 15 mg qd in combination with allopurinol 300 mg (qd and bid)
|
Cohort 2
n=21 participants at risk
RDEA3170 5 mg, 10 mg 20 mg qd in combination with allopurinol 300 mg (qd and bid)
|
|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.0%
2/20 • Number of events 2 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
9.5%
2/21 • Number of events 2 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
14.3%
3/21 • Number of events 3 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/20 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
9.5%
2/21 • Number of events 2 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • Number of events 1 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
0.00%
0/21 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/20 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
4.8%
1/21 • Number of events 1 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/20 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
4.8%
1/21 • Number of events 1 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/20 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
4.8%
1/21 • Number of events 1 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Number of events 2 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
0.00%
0/21 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
|
Gastrointestinal disorders
Toothache
|
5.0%
1/20 • Number of events 1 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
0.00%
0/21 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
|
General disorders
Pyrexia
|
5.0%
1/20 • Number of events 1 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
0.00%
0/21 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
|
Immune system disorders
Seasonal Allergy
|
5.0%
1/20 • Number of events 1 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
0.00%
0/21 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
|
Renal and urinary disorders
Renal Failure Acute
|
5.0%
1/20 • Number of events 1 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
0.00%
0/21 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.00%
0/20 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
4.8%
1/21 • Number of events 1 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.0%
1/20 • Number of events 1 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
0.00%
0/21 • 11 Weeks.
Total # Affected by any Other Adverse Event includes subjects who may appear more than once; Other Adverse Events were reported for 6 subjects in Cohort 1 and 6 subjects in Cohort 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI shall submit a copy of the Publication to Sponsor for review at least 45 days prior to its proposed submission. Sponsor reserves the right to delay any such publication for an additional period of 60 days. Upon Sponsor's request, PI agrees to delete from the proposed publication any Confidential Information. PI agrees not to release any publication without the prior written permission of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER