Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

RDEA3170 and Febuxostat Combination Study in Gout Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02246673
Recruitment Status : Completed
First Posted : September 23, 2014
Results First Posted : July 27, 2017
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gout
Interventions Drug: RDEA3170 15 mg
Drug: RDEA3170 10 mg
Drug: RDEA3170 2.5
Drug: RDEA3170 5 mg
Drug: Febuxostat 40 mg
Drug: Febuxostat 80 mg
Enrollment 64
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5
Hide Arm/Group Description (RDEA3170 10 mg + Febuxostat 40 mg; RDEA3170 10 mg + Febuxostat 80 mg) (RDEA3170 15 mg + Febuxostat 40 mg; RDEA3170 15 mg + Febuxostat 80 mg) (RDEA3170 5 mg + Febuxostat 40 mg; RDEA3170 5 mg + Febuxostat 80 mg) (RDEA3170 2.5 mg + Febuxostat 40 mg; RDEA3170 2.5 mg + Febuxostat 80 mg) (RDEA3170 10 mg + Febuxostat 40 mg; RDEA3170 15 mg + Febuxostat 40 mg; RDEA3170 20 mg + Febuxostat 40 mg)
Period Title: Overall Study
Started 14 12 12 14 12
Completed 13 12 12 12 11
Not Completed 1 0 0 2 1
Reason Not Completed
Sponsor Decision             1             0             0             0             0
Withdrawal by Subject             0             0             0             0             1
Lost to Follow-up             0             0             0             1             0
Protocol Violation             0             0             0             1             0
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 14 12 12 14 12 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 12 participants 12 participants 14 participants 12 participants 64 participants
45  (8.9) 50  (8.2) 50  (8.5) 48  (11.5) 49  (10.9) 48  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 12 participants 12 participants 14 participants 12 participants 64 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
14
 100.0%
12
 100.0%
12
 100.0%
14
 100.0%
12
 100.0%
64
 100.0%
1.Primary Outcome
Title Serum Urate Maximum Percentage (%) Change (Emax, CB)
Hide Description Maximum observed percentage (%) change from baseline in serum urate concentrations.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Febuxostat 40 mg Febuxostat 80 mg RDEA3170 10 mg + Febuxostat 40 mg RDEA3170 10 mg + Febuxostat 80 mg RDEA3170 15 mg + Febuxostat 40 mg RDEA3170 15 mg + Febuxostat 80 mg RDEA3170 5 mg + Febuxostat 40 mg RDEA3170 5 mg + Febuxostat 80 mg RDEA3170 2.5 mg + Febuxostat 40 mg RDEA3170 2.5 mg + Febuxostat 80 mg RDEA3170 20 mg + Febuxostat 40 mg
Hide Arm/Group Description:
Days 7/14/21/28 Overall (Cohorts 1 through 5)
Days 7/28 Overall (Cohorts 1 through 5)
Days 7/14/21/28 Overall (Cohorts 1 and 5)
Days 14/21 Overall (Cohort 1)
Days 7/14/21/28 Overall (Cohorts 2 and 5)
Days 14/21 Overall (Cohort 2)
Days 14/21 Overall (Cohort 3)
Days 14/21 Overall (Cohort 3)
Days 14/21 Overall (Cohort 4)
Days 14/21 Overall (Cohort 4)
Days 14/21 Overall (Cohort 5)
Overall Number of Participants Analyzed 58 47 22 10 23 11 12 12 12 12 11
Mean (Standard Error)
Unit of Measure: Percentage (%)
-43.5  (1.10) -55.6  (1.37) -70.4  (1.35) -79.1  (2.53) -74.9  (1.18) -82.4  (1.76) -59.4  (2.81) -66.7  (2.32) -52.5  (2.51) -62.7  (2.69) -77.3  (1.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 10 mg + Febuxostat 40 mg
Comments Cohort 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value -28.18
Confidence Interval (2-Sided) 95%
-33.85 to -22.51
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg, RDEA3170 10 mg + Febuxostat 80 mg
Comments Cohort 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value -25.29
Confidence Interval (2-Sided) 95%
-31.23 to -19.34
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 15 mg + Febuxostat 40 mg
Comments Cohort 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value -29.15
Confidence Interval (2-Sided) 95%
-33.15 to -25.15
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg, RDEA3170 15 mg + Febuxostat 80 mg
Comments Cohort 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value -22.25
Confidence Interval (2-Sided) 95%
-26.36 to -18.14
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 5 mg + Febuxostat 40 mg
Comments Cohort 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value -17.52
Confidence Interval (2-Sided) 95%
-21.54 to -13.50
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg, RDEA3170 5 mg + Febuxostat 80 mg
Comments Cohort 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value -15.51
Confidence Interval (2-Sided) 95%
-19.53 to -11.49
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 2.5 mg + Febuxostat 40 mg
Comments Cohort 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value -9.74
Confidence Interval (2-Sided) 95%
-13.97 to -5.51
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg, RDEA3170 2.5 mg + Febuxostat 80 mg
Comments Cohort 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0221
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value -4.98
Confidence Interval (2-Sided) 95%
-9.19 to -0.76
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 20 mg + Febuxostat 40 mg
Comments Cohort 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value -35.38
Confidence Interval (2-Sided) 95%
-38.89 to -31.87
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 10 mg + Febuxostat 40 mg
Comments Cohort 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value -27.08
Confidence Interval (2-Sided) 95%
-30.60 to -23.57
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 15 mg + Febuxostat 40 mg
Comments Cohort 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value -31.26
Confidence Interval (2-Sided) 95%
-34.77 to -27.75
Estimation Comments [Not Specified]
2.Primary Outcome
Title Urine Uric Acid % Change (0-24h) (Aeur, CB)
Hide Description Percentage (%) change from baseline in the amount of uric acid recovered in urine.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Febuxostat 40 mg Febuxostat 80 mg RDEA3170 10 mg + Febuxostat 40 mg RDEA3170 10 mg + Febuxostat 80 mg RDEA3170 15 mg + Febuxostat 40 mg RDEA3170 15 mg + Febuxostat 80 mg RDEA3170 5 mg + Febuxostat 40 mg RDEA3170 5 mg + Febuxostat 80 mg RDEA3170 2.5 mg + Febuxostat 40 mg RDEA3170 2.5 mg + Febuxostat 80 mg RDEA3170 20 mg + Febuxostat 40 mg
Hide Arm/Group Description:
Days 7/14/21/28 Overall (Cohorts 1 through 5)
Days 14/21 Overall (Cohorts 1 through 5)
Days 7/14/21/28 Overall (Cohorts 1 and 5)
Days 14/21 Overall (Cohort 1)
Days 7/14/21/28 Overall (Cohorts 2 and 5)
Days 14/21 Overall (Cohort 2)
Days 14/21 Overall (Cohort 3)
Days 14/21 Overall (Cohort 3)
Days 14/21 Overall (Cohort 4)
Days 14/21 Overall (Cohort 4)
Days 14/21 Overall (Cohort 5)
Overall Number of Participants Analyzed 56 45 24 13 22 10 10 10 11 11 10
Mean (Standard Error)
Unit of Measure: Percentage (%)
-48.6  (1.71) -60.3  (1.58) -23.7  (5.56) -36.6  (6.75) -22.9  (4.15) -44.4  (5.57) -26.2  (8.28) -39.2  (5.95) -40.2  (4.07) -61.1  (2.16) -14.2  (10.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 10 mg + Febuxostat 40 mg
Comments Cohort 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 24.27
Confidence Interval (2-Sided) 95%
12.57 to 35.98
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg, RDEA3170 10 mg + Febuxostat 80 mg
Comments Cohort 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 20.08
Confidence Interval (2-Sided) 95%
8.38 to 31.79
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 15 mg + Febuxostat 40 mg
Comments Cohort 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 23.70
Confidence Interval (2-Sided) 95%
14.23 to 33.17
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg, RDEA3170 15 mg + Febuxostat 80 mg
Comments Cohort 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 18.37
Confidence Interval (2-Sided) 95%
8.30 to 28.44
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 5 mg + Febuxostat 40 mg
Comments Cohort 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0101
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 18.82
Confidence Interval (2-Sided) 95%
4.86 to 32.79
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg, RDEA3170 5 mg + Febuxostat 80 mg
Comments Cohort 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0055
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 20.52
Confidence Interval (2-Sided) 95%
6.56 to 34.48
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 2.5 mg + Febuxostat 40 mg
Comments Cohort 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0065
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 10.36
Confidence Interval (2-Sided) 95%
3.13 to 17.59
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg, RDEA3170 2.5 mg + Febuxostat 80 mg
Comments Cohort 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6140
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 1.79
Confidence Interval (2-Sided) 95%
-5.37 to 8.94
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 20 mg + Febuxostat 40 mg
Comments Cohort 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 30.83
Confidence Interval (2-Sided) 95%
15.62 to 46.04
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 10 mg + Febuxostat 40 mg
Comments Cohort 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0019
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 24.38
Confidence Interval (2-Sided) 95%
9.63 to 39.14
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 15 mg + Febuxostat 40 mg
Comments Cohort 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 26.35
Confidence Interval (2-Sided) 95%
11.59 to 41.11
Estimation Comments [Not Specified]
3.Primary Outcome
Title Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)
Hide Description Percentage (%) change from baseline in renal clearance of uric acid.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Febuxostat 40 mg Febuxostat 80 mg RDEA3170 10 mg + Febuxostat 40 mg RDEA3170 10 mg + Febuxostat 80 mg RDEA3170 15 mg + Febuxostat 40 mg RDEA3170 15 mg + Febuxostat 80 mg RDEA3170 5 mg + Febuxostat 40 mg RDEA3170 5 mg + Febuxostat 80 mg RDEA3170 2.5 mg + Febuxostat 40 mg RDEA3170 2.5 mg + Febuxostat 80 mg RDEA3170 20 mg + Febuxostat 40 mg
Hide Arm/Group Description:
Days 7/14/21/28 Overall (Cohorts 1 through 5)
Days 14/21 Overall (Cohorts 1 through 5)
Days 7/14/21/28 Overall (Cohorts 1 and 5)
Days 14/21 Overall (Cohort 1)
Days 7/14/21/28 Overall (Cohorts 2 and 5)
Days 14/21 Overall (Cohort 2)
Days 14/21 Overall (Cohort 3)
Days 14/21 Overall (Cohort 3)
Days 14/21 Overall (Cohort 4)
Days 14/21 Overall (Cohort 4)
Days 14/21 Overall (Cohort 5)
Overall Number of Participants Analyzed 50 37 21 10 20 10 10 10 10 10 9
Mean (Standard Error)
Unit of Measure: Percentage (%)
-15.2  (2.53) -18.8  (2.52) 125  (17.4) 153  (30.5) 157  (15.9) 172  (30.0) 58.7  (15.7) 68.4  (24.7) 20.9  (10.1) 0.011  (7.36) 223  (47.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 10 mg + Febuxostat 40 mg
Comments Cohort 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 139.11
Confidence Interval (2-Sided) 95%
93.92 to 184.31
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg, RDEA3170 10 mg + Febuxostat 80 mg
Comments Cohort 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 174.47
Confidence Interval (2-Sided) 95%
125.52 to 233.42
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 15 mg + Febuxostat 40 mg
Comments Cohort 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 168.03
Confidence Interval (2-Sided) 95%
123.13 to 212.93
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg, RDEA3170 15 mg + Febuxostat 80 mg
Comments Cohort 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 188.75
Confidence Interval (2-Sided) 95%
138.04 to 239.46
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 5 mg + Febuxostat 40 mg
Comments Cohort 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 70.43
Confidence Interval (2-Sided) 95%
33.74 to 107.12
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg, RDEA3170 5 mg + Febuxostat 80 mg
Comments Cohort 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 91.50
Confidence Interval (2-Sided) 95%
54.81 to 128.19
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 2.5 mg + Febuxostat 40 mg
Comments Cohort 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 40.11
Confidence Interval (2-Sided) 95%
25.17 to 55.05
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg, RDEA3170 2.5 mg + Febuxostat 80 mg
Comments Cohort 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0350
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 15.96
Confidence Interval (2-Sided) 95%
1.20 to 30.71
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 20 mg + Febuxostat 40 mg
Comments Cohort 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 236.08
Confidence Interval (2-Sided) 95%
178.29 to 293.86
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 10 mg + Febuxostat 40 mg
Comments Cohort 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 146.20
Confidence Interval (2-Sided) 95%
90.40 to 202.01
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 15 mg + Febuxostat 40 mg
Comments Cohort 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 176.57
Confidence Interval (2-Sided) 95%
120.77 to 232.38
Estimation Comments [Not Specified]
4.Primary Outcome
Title Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)
Hide Description Percentage (%) change from baseline in fractional excretion of uric acid.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Febuxostat 40 mg Febuxostat 80 mg RDEA3170 10 mg + Febuxostat 40 mg RDEA3170 10 mg + Febuxostat 80 mg RDEA3170 15 mg + Febuxostat 40 mg RDEA3170 15 mg + Febuxostat 80 mg RDEA3170 5 mg + Febuxostat 40 mg RDEA3170 5 mg + Febuxostat 80 mg RDEA3170 2.5 mg + Febuxostat 40 mg RDEA3170 2.5 mg + Febuxostat 80 mg RDEA3170 20 mg + Febuxostat 40 mg
Hide Arm/Group Description:
Days 7/14/21/28 Overall (Cohorts 1 through 5)
Days 14/21 Overall (Cohorts 1 through 5)
Days 7/14/21/28 Overall (Cohorts 1 and 5)
Days 14/21 Overall (Cohort 1)
Days 7/14/21/28 Overall (Cohorts 2 and 5)
Days 14/21 Overall (Cohort 2)
Days 14/21 Overall (Cohort 3)
Days 14/21 Overall (Cohort 3)
Days 14/21 Overall (Cohort 4)
Days 14/21 Overall (Cohort 4)
Days 14/21 Overall (Cohort 5)
Overall Number of Participants Analyzed 47 33 21 8 19 10 7 7 10 10 9
Mean (Standard Error)
Unit of Measure: Percentage (%)
-20.6  (1.82) -20.8  (2.62) 100  (13.4) 155  (32.4) 133  (12.2) 152  (26.2) 46.6  (9.36) 54.8  (20.5) 15.2  (9.30) 4.73  (6.15) 162  (23.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 10 mg + Febuxostat 40 mg
Comments Cohort 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 135.82
Confidence Interval (2-Sided) 95%
93.33 to 178.32
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg, RDEA3170 10 mg + Febuxostat 80 mg
Comments Cohort 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 178.58
Confidence Interval (2-Sided) 95%
129.25 to 227.90
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 15 mg + Febuxostat 40 mg
Comments Cohort 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 163.98
Confidence Interval (2-Sided) 95%
120.80 to 207.16
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg, RDEA3170 15 mg + Febuxostat 80 mg
Comments Cohort 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 169.93
Confidence Interval (2-Sided) 95%
122.82 to 217.03
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 5 mg + Febuxostat 40 mg
Comments Cohort 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 59.60
Confidence Interval (2-Sided) 95%
28.85 to 90.34
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg, RDEA3170 5 mg + Febuxostat 80 mg
Comments Cohort 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 73.54
Confidence Interval (2-Sided) 95%
42.79 to 104.28
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 2.5 mg + Febuxostat 40 mg
Comments Cohort 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 33.70
Confidence Interval (2-Sided) 95%
21.21 to 46.20
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg, RDEA3170 2.5 mg + Febuxostat 80 mg
Comments Cohort 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 27.08
Confidence Interval (2-Sided) 95%
14.58 to 39.58
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 20 mg + Febuxostat 40 mg
Comments Cohort 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 188.83
Confidence Interval (2-Sided) 95%
152.55 to 225.10
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 10 mg + Febuxostat 40 mg
Comments Cohort 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 116.83
Confidence Interval (2-Sided) 95%
81.76 to 151.90
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg, RDEA3170 15 mg + Febuxostat 40 mg
Comments Cohort 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model included treatment and period as fixed effects and subject(s) as a random effect.
Method of Estimation Estimation Parameter Geometric Least Squares mean Ratio
Estimated Value 151.66
Confidence Interval (2-Sided) 95%
116.59 to 186.73
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description Cmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Time Frame Days 7 to 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RDEA3170 10 mg + Febuxostat 40 mg RDEA3170 10 mg + Febuxostat 80 mg RDEA3170 15 mg + Febuxostat 40 mg RDEA3170 15 mg + Febuxostat 80 mg RDEA3170 5 mg + Febuxostat 40 mg RDEA3170 5 mg + Febuxostat 80 mg RDEA3170 2.5 mg + Febuxostat 40 mg RDEA3170 2.5 mg + Febuxostat 80 mg RDEA3170 20 mg + Febuxostat 40 mg
Hide Arm/Group Description:
Overall (Cohorts 1 and 5)
Overall (Cohort 1)
Overall (Cohorts 2 and 5)
Overall (Cohort 2)
Overall (Cohort 3)
Overall (Cohort 3)
Overall (Cohort 4)
Overall (Cohort 4)
Overall (Cohort 5)
Overall Number of Participants Analyzed 24 13 23 11 12 12 12 12 11
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL
15.5
(12.9 to 18.6)
16.1
(12.6 to 20.6)
21.2
(18.0 to 25.1)
20.4
(15.8 to 26.2)
7.20
(5.55 to 9.34)
7.54
(5.69 to 9.99)
3.45
(2.63 to 4.52)
3.37
(2.42 to 4.68)
26.1
(20.1 to 33.9)
6.Secondary Outcome
Title Time of Occurrence of Maximum Observed Concentration (Tmax)
Hide Description Tmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Time Frame Days 7 to 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RDEA3170 10 mg + Febuxostat 40 mg RDEA3170 10 mg + Febuxostat 80 mg RDEA3170 15 mg + Febuxostat 40 mg RDEA3170 15 mg + Febuxostat 80 mg RDEA3170 5 mg + Febuxostat 40 mg RDEA3170 5 mg + Febuxostat 80 mg RDEA3170 2.5 mg + Febuxostat 40 mg RDEA3170 2.5 mg + Febuxostat 80 mg RDEA3170 20 mg + Febuxostat 40 mg
Hide Arm/Group Description:
Overall (Cohorts 1 and 5)
Days 14/21 Overall (Cohort 1)
Overall (Cohorts 2 and 5)
Days 14/21 Overall (Cohort 2)
Overall (Cohort 3)
Days 14/21 Overall (Cohort 3)
Overall (Cohort 4)
Days 14/21 Overall (Cohort 4)
Days 14/21 Overall (Cohort 5)
Overall Number of Participants Analyzed 24 13 23 11 12 12 12 12 11
Median (Full Range)
Unit of Measure: hr
3.00
(1.50 to 10.0)
3.00
(1.00 to 12.0)
3.00
(1.50 to 8.00)
4.00
(2.00 to 6.00)
3.50
(2.00 to 6.00)
4.00
(1.50 to 12.0)
3.50
(1.50 to 8.00)
2.50
(1.00 to 10.0)
3.00
(1.50 to 6.00)
7.Secondary Outcome
Title Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
Hide Description AUC 0-24 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Time Frame Days 7 to 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RDEA3170 10 mg + Febuxostat 40 mg RDEA3170 10 mg + Febuxostat 80 mg RDEA3170 15 mg + Febuxostat 40 mg RDEA3170 15 mg + Febuxostat 80 mg RDEA3170 5 mg + Febuxostat 40 mg RDEA3170 5 mg + Febuxostat 80 mg RDEA3170 2.5 mg + Febuxostat 40 mg RDEA3170 2.5 mg + Febuxostat 80 mg RDEA3170 20 mg + Febuxostat 40 mg
Hide Arm/Group Description:
Overall (Cohorts 1 and 5)
Overall (Cohort 1)
Overall (Cohorts 2 and 5)
Overall (Cohort 2)
Overall (Cohort 3)
Overall (Cohort 3)
Overall (Cohort 4)
Overall (Cohort 4)
Overall (Cohort 5)
Overall Number of Participants Analyzed 24 13 23 11 12 12 12 12 11
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng·hr/mL
123
(104 to 146)
138
(106 to 179)
186
(164 to 212)
225
(182 to 278)
62.2
(47.8 to 80.8)
57.6
(46.8 to 70.9)
28.0
(21.2 to 36.9)
27.4
(19.7 to 38.1)
216
(173 to 270)
8.Secondary Outcome
Title Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
Hide Description AUC last of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Time Frame Days 7 to 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RDEA3170 10 mg + Febuxostat 40 mg RDEA3170 10 mg + Febuxostat 80 mg RDEA3170 15 mg + Febuxostat 40 mg RDEA3170 15 mg + Febuxostat 80 mg RDEA3170 5 mg + Febuxostat 40 mg RDEA3170 5 mg + Febuxostat 80 mg RDEA3170 2.5 mg + Febuxostat 40 mg RDEA3170 2.5 mg + Febuxostat 80 mg RDEA3170 20 mg + Febuxostat 40 mg
Hide Arm/Group Description:
Overall (Cohorts 1 and 5)
Overall (Cohort 1)
Overall (Cohorts 2 and 5)
Overall (Cohort 2)
Overall (Cohort 3)
Overall (Cohort 3)
Overall (Cohort 4)
Overall (Cohort 4)
Overall (Cohort 5)
Overall Number of Participants Analyzed 24 13 23 11 12 12 12 12 11
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng·hr/mL
123
(104 to 146)
138
(106 to 179)
186
(164 to 212)
225
(182 to 278)
62.2
(47.8 to 80.8)
62.6
(48.2 to 81.3)
28.0
(21.2 to 36.9)
26.8
(18.8 to 38.3)
216
(173 to 270)
9.Secondary Outcome
Title Apparent Terminal Half-life (t1/2)
Hide Description t1/2 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Time Frame Days 7 to 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RDEA3170 10 mg + Febuxostat 40 mg RDEA3170 10 mg + Febuxostat 80 mg RDEA3170 15 mg + Febuxostat 40 mg RDEA3170 15 mg + Febuxostat 80 mg RDEA3170 5 mg + Febuxostat 40 mg RDEA3170 5 mg + Febuxostat 80 mg RDEA3170 2.5 mg + Febuxostat 40 mg RDEA3170 2.5 mg + Febuxostat 80 mg RDEA3170 20 mg + Febuxostat 40 mg
Hide Arm/Group Description:
Overall (Cohorts 1 and 5)
Overall (Cohort 1)
Overall (Cohorts 2 and 5)
Overall (Cohort 2)
Overall (Cohort 3)
Overall (Cohort 3)
Overall (Cohort 4)
Overall (Cohort 4)
Overall (Cohort 5)
Overall Number of Participants Analyzed 24 12 23 11 12 11 12 12 11
Geometric Mean (95% Confidence Interval)
Unit of Measure: hr
8.26
(6.71 to 10.2)
9.64
(6.77 to 13.7)
10.6
(8.41 to 13.3)
10.8
(8.17 to 14.3)
13.2
(8.11 to 21.4)
11.3
(7.09 to 18.1)
13.0
(8.89 to 19.1)
12.5
(8.18 to 19.2)
11.6
(7.17 to 18.8)
10.Secondary Outcome
Title Incidence of Treatment-Emergent Adverse Events
Hide Description [Not Specified]
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Febuxostat 40 mg Febuxostat 80 mg RDEA3170 10 mg + Febuxostat 40 mg RDEA3170 10 mg + Febuxostat 80 mg RDEA3170 15 mg + Febuxostat 40 mg RDEA3170 15 mg + Febuxostat 80 mg RDEA3170 5 mg + Febuxostat 40 mg RDEA3170 5 mg + Febuxostat 80 mg RDEA3170 2.5 mg + Febuxostat 40 mg RDEA3170 2.5 mg + Febuxostat 80 mg RDEA3170 20 mg + Febuxostat 40 mg
Hide Arm/Group Description:
Overall (Cohorts 1 through 5)
Overall (Cohorts 1 through 5)
Overall (Cohorts 1 and 5)
Overall (Cohort 1)
Overall (Cohorts 2 and 5)
Overall (Cohort 2)
Overall (Cohort 3)
Overall (Cohort 3)
Overall (Cohort 4)
Overall (Cohort 4)
Overall (Cohort 5)
Overall Number of Participants Analyzed 61 51 25 13 23 12 12 12 12 13 11
Measure Type: Number
Unit of Measure: Number of participants
3 8 4 6 1 0 0 1 1 0 2
Time Frame 10 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Febuxostat 40 mg Febuxostat 80 mg Overall RDEA3170 + Febuxostat Combination
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Febuxostat 40 mg Febuxostat 80 mg Overall RDEA3170 + Febuxostat Combination
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Febuxostat 40 mg Febuxostat 80 mg Overall RDEA3170 + Febuxostat Combination
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/61 (0.00%)      0/51 (0.00%)      0/62 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Febuxostat 40 mg Febuxostat 80 mg Overall RDEA3170 + Febuxostat Combination
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/61 (4.92%)      8/51 (15.69%)      13/62 (20.97%)    
Ear and labyrinth disorders       
Tympanic Membrane Hyperaemia  1  0/61 (0.00%)  0 1/51 (1.96%)  1 0/62 (0.00%)  0
Gastrointestinal disorders       
Dyspepsia  1  1/61 (1.64%)  1 0/51 (0.00%)  0 2/62 (3.23%)  2
Aphthous Stomatitis  1  0/61 (0.00%)  0 0/51 (0.00%)  0 1/62 (1.61%)  2
Constipation  1  1/61 (1.64%)  1 0/51 (0.00%)  0 0/62 (0.00%)  0
Diarrhoea  1  0/61 (0.00%)  0 0/51 (0.00%)  0 1/62 (1.61%)  1
General disorders       
Fatigue  1  0/61 (0.00%)  0 0/51 (0.00%)  0 1/62 (1.61%)  1
Hepatobiliary disorders       
Hepatitis  1  0/61 (0.00%)  0 1/51 (1.96%)  1 0/62 (0.00%)  0
Hepatitis Acute  1  0/61 (0.00%)  0 1/51 (1.96%)  1 0/62 (0.00%)  0
Infections and infestations       
Herpes Simplex  1  0/61 (0.00%)  0 0/51 (0.00%)  0 1/62 (1.61%)  1
Pharyngitis  1  0/61 (0.00%)  0 0/51 (0.00%)  0 1/62 (1.61%)  1
Upper Respiratory Tract Infection  1  0/61 (0.00%)  0 0/51 (0.00%)  0 1/62 (1.61%)  1
Injury, poisoning and procedural complications       
Excoriation  1  0/61 (0.00%)  0 1/51 (1.96%)  1 0/62 (0.00%)  0
Investigations       
Hepatic Enzyme Increased  1  1/61 (1.64%)  1 0/51 (0.00%)  0 0/62 (0.00%)  0
Metabolism and nutrition disorders       
Decreased Appetite  1  0/61 (0.00%)  0 1/51 (1.96%)  1 0/62 (0.00%)  0
Hypertriglyceridaemia  1  0/61 (0.00%)  0 1/51 (1.96%)  1 0/62 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Pain In Extremity  1  0/61 (0.00%)  0 0/51 (0.00%)  0 3/62 (4.84%)  3
Musculoskeletal Pain  1  0/61 (0.00%)  0 0/51 (0.00%)  0 2/62 (3.23%)  2
Nervous system disorders       
Headache  1  0/61 (0.00%)  0 1/51 (1.96%)  1 1/62 (1.61%)  1
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/61 (0.00%)  0 0/51 (0.00%)  0 1/62 (1.61%)  1
Oropharyngeal Pain  1  0/61 (0.00%)  0 0/51 (0.00%)  0 1/62 (1.61%)  1
Productive Cough  1  0/61 (0.00%)  0 0/51 (0.00%)  0 1/62 (1.61%)  1
Throat Irritation  1  0/61 (0.00%)  0 0/51 (0.00%)  0 1/62 (1.61%)  1
Vascular disorders       
Hypertension  1  0/61 (0.00%)  0 1/51 (1.96%)  1 0/62 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Jesse Hall, MD
Organization: Study Information Center AstraZeneca
Phone: +1 877-240-9479
Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02246673     History of Changes
Other Study ID Numbers: RDEA3170-204
First Submitted: September 19, 2014
First Posted: September 23, 2014
Results First Submitted: June 27, 2017
Results First Posted: July 27, 2017
Last Update Posted: July 27, 2017