Trial Outcomes & Findings for RDEA3170 and Febuxostat Combination Study in Gout Subjects (NCT NCT02246673)
NCT ID: NCT02246673
Last Updated: 2017-07-27
Results Overview
Maximum observed percentage (%) change from baseline in serum urate concentrations.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
28 days
Results posted on
2017-07-27
Participant Flow
Sixty-four subjects were randomized and received at least 1 dose of randomized study medication. Five cohorts of approximately 12 adult subjects with gout per cohort were randomized into the study. Overall, a total of 60 subjects completed the study in accordance with the protocol.
Cohorts 1 through 4 were conducted sequentially and Cohort 5 was conducted following review of the available PD/PK results of Cohort 2. Subjects in Cohorts 1 through 4 were randomized to 1 of 2 treatment sequences (ABCD or DCBA) in a 1:1 ration and subjects in Cohort 5 were randomized to 1 of 2 treatment sequences (EHGF or GFHE) in a 1:1 ratio.
Participant milestones
| Measure |
Cohort 1
(RDEA3170 10 mg + Febuxostat 40 mg; RDEA3170 10 mg + Febuxostat 80 mg)
|
Cohort 2
(RDEA3170 15 mg + Febuxostat 40 mg; RDEA3170 15 mg + Febuxostat 80 mg)
|
Cohort 3
(RDEA3170 5 mg + Febuxostat 40 mg; RDEA3170 5 mg + Febuxostat 80 mg)
|
Cohort 4
(RDEA3170 2.5 mg + Febuxostat 40 mg; RDEA3170 2.5 mg + Febuxostat 80 mg)
|
Cohort 5
(RDEA3170 10 mg + Febuxostat 40 mg; RDEA3170 15 mg + Febuxostat 40 mg; RDEA3170 20 mg + Febuxostat 40 mg)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
12
|
14
|
12
|
|
Overall Study
COMPLETED
|
13
|
12
|
12
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1
(RDEA3170 10 mg + Febuxostat 40 mg; RDEA3170 10 mg + Febuxostat 80 mg)
|
Cohort 2
(RDEA3170 15 mg + Febuxostat 40 mg; RDEA3170 15 mg + Febuxostat 80 mg)
|
Cohort 3
(RDEA3170 5 mg + Febuxostat 40 mg; RDEA3170 5 mg + Febuxostat 80 mg)
|
Cohort 4
(RDEA3170 2.5 mg + Febuxostat 40 mg; RDEA3170 2.5 mg + Febuxostat 80 mg)
|
Cohort 5
(RDEA3170 10 mg + Febuxostat 40 mg; RDEA3170 15 mg + Febuxostat 40 mg; RDEA3170 20 mg + Febuxostat 40 mg)
|
|---|---|---|---|---|---|
|
Overall Study
Sponsor Decision
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
RDEA3170 and Febuxostat Combination Study in Gout Subjects
Baseline characteristics by cohort
| Measure |
Cohort 1
n=14 Participants
|
Cohort 2
n=12 Participants
|
Cohort 3
n=12 Participants
|
Cohort 4
n=14 Participants
|
Cohort 5
n=12 Participants
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
45 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
50 Years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
50 Years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
48 Years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
49 Years
STANDARD_DEVIATION 10.9 • n=21 Participants
|
48 Years
STANDARD_DEVIATION 9.6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
64 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 28 daysMaximum observed percentage (%) change from baseline in serum urate concentrations.
Outcome measures
| Measure |
Febuxostat 40 mg
n=58 Participants
Days 7/14/21/28 Overall (Cohorts 1 through 5)
|
Febuxostat 80 mg
n=47 Participants
Days 7/28 Overall (Cohorts 1 through 5)
|
RDEA3170 10 mg + Febuxostat 40 mg
n=22 Participants
Days 7/14/21/28 Overall (Cohorts 1 and 5)
|
RDEA3170 10 mg + Febuxostat 80 mg
n=10 Participants
Days 14/21 Overall (Cohort 1)
|
RDEA3170 15 mg + Febuxostat 40 mg
n=23 Participants
Days 7/14/21/28 Overall (Cohorts 2 and 5)
|
RDEA3170 15 mg + Febuxostat 80 mg
n=11 Participants
Days 14/21 Overall (Cohort 2)
|
RDEA3170 5 mg + Febuxostat 40 mg
n=12 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 5 mg + Febuxostat 80 mg
n=12 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 2.5 mg + Febuxostat 40 mg
n=12 Participants
Days 14/21 Overall (Cohort 4)
|
RDEA3170 2.5 mg + Febuxostat 80 mg
n=12 Participants
Days 14/21 Overall (Cohort 4)
|
RDEA3170 20 mg + Febuxostat 40 mg
n=11 Participants
Days 14/21 Overall (Cohort 5)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum Urate Maximum Percentage (%) Change (Emax, CB)
|
-43.5 Percentage (%)
Standard Error 1.10
|
-55.6 Percentage (%)
Standard Error 1.37
|
-70.4 Percentage (%)
Standard Error 1.35
|
-79.1 Percentage (%)
Standard Error 2.53
|
-74.9 Percentage (%)
Standard Error 1.18
|
-82.4 Percentage (%)
Standard Error 1.76
|
-59.4 Percentage (%)
Standard Error 2.81
|
-66.7 Percentage (%)
Standard Error 2.32
|
-52.5 Percentage (%)
Standard Error 2.51
|
-62.7 Percentage (%)
Standard Error 2.69
|
-77.3 Percentage (%)
Standard Error 1.18
|
PRIMARY outcome
Timeframe: 28 daysPercentage (%) change from baseline in the amount of uric acid recovered in urine.
Outcome measures
| Measure |
Febuxostat 40 mg
n=56 Participants
Days 7/14/21/28 Overall (Cohorts 1 through 5)
|
Febuxostat 80 mg
n=45 Participants
Days 7/28 Overall (Cohorts 1 through 5)
|
RDEA3170 10 mg + Febuxostat 40 mg
n=24 Participants
Days 7/14/21/28 Overall (Cohorts 1 and 5)
|
RDEA3170 10 mg + Febuxostat 80 mg
n=13 Participants
Days 14/21 Overall (Cohort 1)
|
RDEA3170 15 mg + Febuxostat 40 mg
n=22 Participants
Days 7/14/21/28 Overall (Cohorts 2 and 5)
|
RDEA3170 15 mg + Febuxostat 80 mg
n=10 Participants
Days 14/21 Overall (Cohort 2)
|
RDEA3170 5 mg + Febuxostat 40 mg
n=10 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 5 mg + Febuxostat 80 mg
n=10 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 2.5 mg + Febuxostat 40 mg
n=11 Participants
Days 14/21 Overall (Cohort 4)
|
RDEA3170 2.5 mg + Febuxostat 80 mg
n=11 Participants
Days 14/21 Overall (Cohort 4)
|
RDEA3170 20 mg + Febuxostat 40 mg
n=10 Participants
Days 14/21 Overall (Cohort 5)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Urine Uric Acid % Change (0-24h) (Aeur, CB)
|
-48.6 Percentage (%)
Standard Error 1.71
|
-60.3 Percentage (%)
Standard Error 1.58
|
-23.7 Percentage (%)
Standard Error 5.56
|
-36.6 Percentage (%)
Standard Error 6.75
|
-22.9 Percentage (%)
Standard Error 4.15
|
-44.4 Percentage (%)
Standard Error 5.57
|
-26.2 Percentage (%)
Standard Error 8.28
|
-39.2 Percentage (%)
Standard Error 5.95
|
-40.2 Percentage (%)
Standard Error 4.07
|
-61.1 Percentage (%)
Standard Error 2.16
|
-14.2 Percentage (%)
Standard Error 10.9
|
PRIMARY outcome
Timeframe: 28 daysPercentage (%) change from baseline in renal clearance of uric acid.
Outcome measures
| Measure |
Febuxostat 40 mg
n=50 Participants
Days 7/14/21/28 Overall (Cohorts 1 through 5)
|
Febuxostat 80 mg
n=37 Participants
Days 7/28 Overall (Cohorts 1 through 5)
|
RDEA3170 10 mg + Febuxostat 40 mg
n=21 Participants
Days 7/14/21/28 Overall (Cohorts 1 and 5)
|
RDEA3170 10 mg + Febuxostat 80 mg
n=10 Participants
Days 14/21 Overall (Cohort 1)
|
RDEA3170 15 mg + Febuxostat 40 mg
n=20 Participants
Days 7/14/21/28 Overall (Cohorts 2 and 5)
|
RDEA3170 15 mg + Febuxostat 80 mg
n=10 Participants
Days 14/21 Overall (Cohort 2)
|
RDEA3170 5 mg + Febuxostat 40 mg
n=10 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 5 mg + Febuxostat 80 mg
n=10 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 2.5 mg + Febuxostat 40 mg
n=10 Participants
Days 14/21 Overall (Cohort 4)
|
RDEA3170 2.5 mg + Febuxostat 80 mg
n=10 Participants
Days 14/21 Overall (Cohort 4)
|
RDEA3170 20 mg + Febuxostat 40 mg
n=9 Participants
Days 14/21 Overall (Cohort 5)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)
|
-15.2 Percentage (%)
Standard Error 2.53
|
-18.8 Percentage (%)
Standard Error 2.52
|
125 Percentage (%)
Standard Error 17.4
|
153 Percentage (%)
Standard Error 30.5
|
157 Percentage (%)
Standard Error 15.9
|
172 Percentage (%)
Standard Error 30.0
|
58.7 Percentage (%)
Standard Error 15.7
|
68.4 Percentage (%)
Standard Error 24.7
|
20.9 Percentage (%)
Standard Error 10.1
|
0.011 Percentage (%)
Standard Error 7.36
|
223 Percentage (%)
Standard Error 47.0
|
PRIMARY outcome
Timeframe: 28 daysPercentage (%) change from baseline in fractional excretion of uric acid.
Outcome measures
| Measure |
Febuxostat 40 mg
n=47 Participants
Days 7/14/21/28 Overall (Cohorts 1 through 5)
|
Febuxostat 80 mg
n=33 Participants
Days 7/28 Overall (Cohorts 1 through 5)
|
RDEA3170 10 mg + Febuxostat 40 mg
n=21 Participants
Days 7/14/21/28 Overall (Cohorts 1 and 5)
|
RDEA3170 10 mg + Febuxostat 80 mg
n=8 Participants
Days 14/21 Overall (Cohort 1)
|
RDEA3170 15 mg + Febuxostat 40 mg
n=19 Participants
Days 7/14/21/28 Overall (Cohorts 2 and 5)
|
RDEA3170 15 mg + Febuxostat 80 mg
n=10 Participants
Days 14/21 Overall (Cohort 2)
|
RDEA3170 5 mg + Febuxostat 40 mg
n=7 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 5 mg + Febuxostat 80 mg
n=7 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 2.5 mg + Febuxostat 40 mg
n=10 Participants
Days 14/21 Overall (Cohort 4)
|
RDEA3170 2.5 mg + Febuxostat 80 mg
n=10 Participants
Days 14/21 Overall (Cohort 4)
|
RDEA3170 20 mg + Febuxostat 40 mg
n=9 Participants
Days 14/21 Overall (Cohort 5)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)
|
-20.6 Percentage (%)
Standard Error 1.82
|
-20.8 Percentage (%)
Standard Error 2.62
|
100 Percentage (%)
Standard Error 13.4
|
155 Percentage (%)
Standard Error 32.4
|
133 Percentage (%)
Standard Error 12.2
|
152 Percentage (%)
Standard Error 26.2
|
46.6 Percentage (%)
Standard Error 9.36
|
54.8 Percentage (%)
Standard Error 20.5
|
15.2 Percentage (%)
Standard Error 9.30
|
4.73 Percentage (%)
Standard Error 6.15
|
162 Percentage (%)
Standard Error 23.2
|
SECONDARY outcome
Timeframe: Days 7 to 28Cmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Outcome measures
| Measure |
Febuxostat 40 mg
n=24 Participants
Days 7/14/21/28 Overall (Cohorts 1 through 5)
|
Febuxostat 80 mg
n=13 Participants
Days 7/28 Overall (Cohorts 1 through 5)
|
RDEA3170 10 mg + Febuxostat 40 mg
n=23 Participants
Days 7/14/21/28 Overall (Cohorts 1 and 5)
|
RDEA3170 10 mg + Febuxostat 80 mg
n=11 Participants
Days 14/21 Overall (Cohort 1)
|
RDEA3170 15 mg + Febuxostat 40 mg
n=12 Participants
Days 7/14/21/28 Overall (Cohorts 2 and 5)
|
RDEA3170 15 mg + Febuxostat 80 mg
n=12 Participants
Days 14/21 Overall (Cohort 2)
|
RDEA3170 5 mg + Febuxostat 40 mg
n=12 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 5 mg + Febuxostat 80 mg
n=12 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 2.5 mg + Febuxostat 40 mg
n=11 Participants
Days 14/21 Overall (Cohort 4)
|
RDEA3170 2.5 mg + Febuxostat 80 mg
Days 14/21 Overall (Cohort 4)
|
RDEA3170 20 mg + Febuxostat 40 mg
Days 14/21 Overall (Cohort 5)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
15.5 ng/mL
Interval 12.9 to 18.6
|
16.1 ng/mL
Interval 12.6 to 20.6
|
21.2 ng/mL
Interval 18.0 to 25.1
|
20.4 ng/mL
Interval 15.8 to 26.2
|
7.20 ng/mL
Interval 5.55 to 9.34
|
7.54 ng/mL
Interval 5.69 to 9.99
|
3.45 ng/mL
Interval 2.63 to 4.52
|
3.37 ng/mL
Interval 2.42 to 4.68
|
26.1 ng/mL
Interval 20.1 to 33.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 7 to 28Tmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Outcome measures
| Measure |
Febuxostat 40 mg
n=24 Participants
Days 7/14/21/28 Overall (Cohorts 1 through 5)
|
Febuxostat 80 mg
n=13 Participants
Days 7/28 Overall (Cohorts 1 through 5)
|
RDEA3170 10 mg + Febuxostat 40 mg
n=23 Participants
Days 7/14/21/28 Overall (Cohorts 1 and 5)
|
RDEA3170 10 mg + Febuxostat 80 mg
n=11 Participants
Days 14/21 Overall (Cohort 1)
|
RDEA3170 15 mg + Febuxostat 40 mg
n=12 Participants
Days 7/14/21/28 Overall (Cohorts 2 and 5)
|
RDEA3170 15 mg + Febuxostat 80 mg
n=12 Participants
Days 14/21 Overall (Cohort 2)
|
RDEA3170 5 mg + Febuxostat 40 mg
n=12 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 5 mg + Febuxostat 80 mg
n=12 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 2.5 mg + Febuxostat 40 mg
n=11 Participants
Days 14/21 Overall (Cohort 4)
|
RDEA3170 2.5 mg + Febuxostat 80 mg
Days 14/21 Overall (Cohort 4)
|
RDEA3170 20 mg + Febuxostat 40 mg
Days 14/21 Overall (Cohort 5)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time of Occurrence of Maximum Observed Concentration (Tmax)
|
3.00 hr
Interval 1.5 to 10.0
|
3.00 hr
Interval 1.0 to 12.0
|
3.00 hr
Interval 1.5 to 8.0
|
4.00 hr
Interval 2.0 to 6.0
|
3.50 hr
Interval 2.0 to 6.0
|
4.00 hr
Interval 1.5 to 12.0
|
3.50 hr
Interval 1.5 to 8.0
|
2.50 hr
Interval 1.0 to 10.0
|
3.00 hr
Interval 1.5 to 6.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 7 to 28AUC 0-24 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Outcome measures
| Measure |
Febuxostat 40 mg
n=24 Participants
Days 7/14/21/28 Overall (Cohorts 1 through 5)
|
Febuxostat 80 mg
n=13 Participants
Days 7/28 Overall (Cohorts 1 through 5)
|
RDEA3170 10 mg + Febuxostat 40 mg
n=23 Participants
Days 7/14/21/28 Overall (Cohorts 1 and 5)
|
RDEA3170 10 mg + Febuxostat 80 mg
n=11 Participants
Days 14/21 Overall (Cohort 1)
|
RDEA3170 15 mg + Febuxostat 40 mg
n=12 Participants
Days 7/14/21/28 Overall (Cohorts 2 and 5)
|
RDEA3170 15 mg + Febuxostat 80 mg
n=12 Participants
Days 14/21 Overall (Cohort 2)
|
RDEA3170 5 mg + Febuxostat 40 mg
n=12 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 5 mg + Febuxostat 80 mg
n=12 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 2.5 mg + Febuxostat 40 mg
n=11 Participants
Days 14/21 Overall (Cohort 4)
|
RDEA3170 2.5 mg + Febuxostat 80 mg
Days 14/21 Overall (Cohort 4)
|
RDEA3170 20 mg + Febuxostat 40 mg
Days 14/21 Overall (Cohort 5)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
|
123 ng·hr/mL
Interval 104.0 to 146.0
|
138 ng·hr/mL
Interval 106.0 to 179.0
|
186 ng·hr/mL
Interval 164.0 to 212.0
|
225 ng·hr/mL
Interval 182.0 to 278.0
|
62.2 ng·hr/mL
Interval 47.8 to 80.8
|
57.6 ng·hr/mL
Interval 46.8 to 70.9
|
28.0 ng·hr/mL
Interval 21.2 to 36.9
|
27.4 ng·hr/mL
Interval 19.7 to 38.1
|
216 ng·hr/mL
Interval 173.0 to 270.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 7 to 28AUC last of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Outcome measures
| Measure |
Febuxostat 40 mg
n=24 Participants
Days 7/14/21/28 Overall (Cohorts 1 through 5)
|
Febuxostat 80 mg
n=13 Participants
Days 7/28 Overall (Cohorts 1 through 5)
|
RDEA3170 10 mg + Febuxostat 40 mg
n=23 Participants
Days 7/14/21/28 Overall (Cohorts 1 and 5)
|
RDEA3170 10 mg + Febuxostat 80 mg
n=11 Participants
Days 14/21 Overall (Cohort 1)
|
RDEA3170 15 mg + Febuxostat 40 mg
n=12 Participants
Days 7/14/21/28 Overall (Cohorts 2 and 5)
|
RDEA3170 15 mg + Febuxostat 80 mg
n=12 Participants
Days 14/21 Overall (Cohort 2)
|
RDEA3170 5 mg + Febuxostat 40 mg
n=12 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 5 mg + Febuxostat 80 mg
n=12 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 2.5 mg + Febuxostat 40 mg
n=11 Participants
Days 14/21 Overall (Cohort 4)
|
RDEA3170 2.5 mg + Febuxostat 80 mg
Days 14/21 Overall (Cohort 4)
|
RDEA3170 20 mg + Febuxostat 40 mg
Days 14/21 Overall (Cohort 5)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
|
123 ng·hr/mL
Interval 104.0 to 146.0
|
138 ng·hr/mL
Interval 106.0 to 179.0
|
186 ng·hr/mL
Interval 164.0 to 212.0
|
225 ng·hr/mL
Interval 182.0 to 278.0
|
62.2 ng·hr/mL
Interval 47.8 to 80.8
|
62.6 ng·hr/mL
Interval 48.2 to 81.3
|
28.0 ng·hr/mL
Interval 21.2 to 36.9
|
26.8 ng·hr/mL
Interval 18.8 to 38.3
|
216 ng·hr/mL
Interval 173.0 to 270.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 7 to 28t1/2 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Outcome measures
| Measure |
Febuxostat 40 mg
n=24 Participants
Days 7/14/21/28 Overall (Cohorts 1 through 5)
|
Febuxostat 80 mg
n=12 Participants
Days 7/28 Overall (Cohorts 1 through 5)
|
RDEA3170 10 mg + Febuxostat 40 mg
n=23 Participants
Days 7/14/21/28 Overall (Cohorts 1 and 5)
|
RDEA3170 10 mg + Febuxostat 80 mg
n=11 Participants
Days 14/21 Overall (Cohort 1)
|
RDEA3170 15 mg + Febuxostat 40 mg
n=12 Participants
Days 7/14/21/28 Overall (Cohorts 2 and 5)
|
RDEA3170 15 mg + Febuxostat 80 mg
n=11 Participants
Days 14/21 Overall (Cohort 2)
|
RDEA3170 5 mg + Febuxostat 40 mg
n=12 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 5 mg + Febuxostat 80 mg
n=12 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 2.5 mg + Febuxostat 40 mg
n=11 Participants
Days 14/21 Overall (Cohort 4)
|
RDEA3170 2.5 mg + Febuxostat 80 mg
Days 14/21 Overall (Cohort 4)
|
RDEA3170 20 mg + Febuxostat 40 mg
Days 14/21 Overall (Cohort 5)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2)
|
8.26 hr
Interval 6.71 to 10.2
|
9.64 hr
Interval 6.77 to 13.7
|
10.6 hr
Interval 8.41 to 13.3
|
10.8 hr
Interval 8.17 to 14.3
|
13.2 hr
Interval 8.11 to 21.4
|
11.3 hr
Interval 7.09 to 18.1
|
13.0 hr
Interval 8.89 to 19.1
|
12.5 hr
Interval 8.18 to 19.2
|
11.6 hr
Interval 7.17 to 18.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 10 weeksOutcome measures
| Measure |
Febuxostat 40 mg
n=61 Participants
Days 7/14/21/28 Overall (Cohorts 1 through 5)
|
Febuxostat 80 mg
n=51 Participants
Days 7/28 Overall (Cohorts 1 through 5)
|
RDEA3170 10 mg + Febuxostat 40 mg
n=25 Participants
Days 7/14/21/28 Overall (Cohorts 1 and 5)
|
RDEA3170 10 mg + Febuxostat 80 mg
n=13 Participants
Days 14/21 Overall (Cohort 1)
|
RDEA3170 15 mg + Febuxostat 40 mg
n=23 Participants
Days 7/14/21/28 Overall (Cohorts 2 and 5)
|
RDEA3170 15 mg + Febuxostat 80 mg
n=12 Participants
Days 14/21 Overall (Cohort 2)
|
RDEA3170 5 mg + Febuxostat 40 mg
n=12 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 5 mg + Febuxostat 80 mg
n=12 Participants
Days 14/21 Overall (Cohort 3)
|
RDEA3170 2.5 mg + Febuxostat 40 mg
n=12 Participants
Days 14/21 Overall (Cohort 4)
|
RDEA3170 2.5 mg + Febuxostat 80 mg
n=13 Participants
Days 14/21 Overall (Cohort 4)
|
RDEA3170 20 mg + Febuxostat 40 mg
n=11 Participants
Days 14/21 Overall (Cohort 5)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events
|
3 Number of participants
|
8 Number of participants
|
4 Number of participants
|
6 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
1 Number of participants
|
0 Number of participants
|
2 Number of participants
|
Adverse Events
Febuxostat 40 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Febuxostat 80 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Overall RDEA3170 + Febuxostat Combination
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Febuxostat 40 mg
n=61 participants at risk
|
Febuxostat 80 mg
n=51 participants at risk
|
Overall RDEA3170 + Febuxostat Combination
n=62 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
1/61 • Number of events 1 • 10 weeks
|
0.00%
0/51 • 10 weeks
|
3.2%
2/62 • Number of events 2 • 10 weeks
|
|
Gastrointestinal disorders
Aphthous Stomatitis
|
0.00%
0/61 • 10 weeks
|
0.00%
0/51 • 10 weeks
|
1.6%
1/62 • Number of events 2 • 10 weeks
|
|
Gastrointestinal disorders
Constipation
|
1.6%
1/61 • Number of events 1 • 10 weeks
|
0.00%
0/51 • 10 weeks
|
0.00%
0/62 • 10 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/61 • 10 weeks
|
0.00%
0/51 • 10 weeks
|
1.6%
1/62 • Number of events 1 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/61 • 10 weeks
|
0.00%
0/51 • 10 weeks
|
4.8%
3/62 • Number of events 3 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/61 • 10 weeks
|
0.00%
0/51 • 10 weeks
|
3.2%
2/62 • Number of events 2 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/61 • 10 weeks
|
0.00%
0/51 • 10 weeks
|
1.6%
1/62 • Number of events 1 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/61 • 10 weeks
|
0.00%
0/51 • 10 weeks
|
1.6%
1/62 • Number of events 1 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/61 • 10 weeks
|
0.00%
0/51 • 10 weeks
|
1.6%
1/62 • Number of events 1 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/61 • 10 weeks
|
0.00%
0/51 • 10 weeks
|
1.6%
1/62 • Number of events 1 • 10 weeks
|
|
Infections and infestations
Herpes Simplex
|
0.00%
0/61 • 10 weeks
|
0.00%
0/51 • 10 weeks
|
1.6%
1/62 • Number of events 1 • 10 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/61 • 10 weeks
|
0.00%
0/51 • 10 weeks
|
1.6%
1/62 • Number of events 1 • 10 weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/61 • 10 weeks
|
0.00%
0/51 • 10 weeks
|
1.6%
1/62 • Number of events 1 • 10 weeks
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/61 • 10 weeks
|
2.0%
1/51 • Number of events 1 • 10 weeks
|
0.00%
0/62 • 10 weeks
|
|
Hepatobiliary disorders
Hepatitis Acute
|
0.00%
0/61 • 10 weeks
|
2.0%
1/51 • Number of events 1 • 10 weeks
|
0.00%
0/62 • 10 weeks
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/61 • 10 weeks
|
2.0%
1/51 • Number of events 1 • 10 weeks
|
0.00%
0/62 • 10 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/61 • 10 weeks
|
2.0%
1/51 • Number of events 1 • 10 weeks
|
0.00%
0/62 • 10 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/61 • 10 weeks
|
2.0%
1/51 • Number of events 1 • 10 weeks
|
1.6%
1/62 • Number of events 1 • 10 weeks
|
|
Ear and labyrinth disorders
Tympanic Membrane Hyperaemia
|
0.00%
0/61 • 10 weeks
|
2.0%
1/51 • Number of events 1 • 10 weeks
|
0.00%
0/62 • 10 weeks
|
|
General disorders
Fatigue
|
0.00%
0/61 • 10 weeks
|
0.00%
0/51 • 10 weeks
|
1.6%
1/62 • Number of events 1 • 10 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/61 • 10 weeks
|
2.0%
1/51 • Number of events 1 • 10 weeks
|
0.00%
0/62 • 10 weeks
|
|
Investigations
Hepatic Enzyme Increased
|
1.6%
1/61 • Number of events 1 • 10 weeks
|
0.00%
0/51 • 10 weeks
|
0.00%
0/62 • 10 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/61 • 10 weeks
|
2.0%
1/51 • Number of events 1 • 10 weeks
|
0.00%
0/62 • 10 weeks
|
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