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Phase 2a RDEA3170 and Allopurinol 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: NCT02498652
Recruitment Status : Completed
First Posted : July 15, 2015
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
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 2.5 mg
Drug: allopurinol 300 mg
Enrollment 41
Recruitment Details 41 subjects were randomized.
Pre-assignment Details 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.
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description Allopurinol 300 mg once daily (qd), 600 mg qd, RDEA3170 2.5 mg qd, 15 mg qd and 7.5 mg qd Allopurinol 300 mg qd, 600 mg (300 mg bid), RDEA3170 5 mg qd, 20 mg qd and 10 mg qd
Period Title: Overall Study
Started 20 21
Completed 20 20 [1]
Not Completed 0 1
Reason Not Completed
Protocol Violation             0             1
[1]
One subject was withdrawn due to noncompliance/protocol violation
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description Allopurinol 300 mg once daily (qd), 600 mg qd, RDEA3170 2.5 mg qd, 15 mg qd and 7.5 mg qd Allopurinol 300 mg qd, 600 mg (300 mg bid), RDEA3170 5 mg qd, 20 mg qd and 10 mg qd Total of all reporting groups
Overall Number of Baseline Participants 20 21 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 21 participants 41 participants
50  (12.7) 48  (10.9) 49  (11.7)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
Male 1 0 1
Female 19 21 40
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 21 participants 41 participants
20 21 41
1.Primary Outcome
Title Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))
Hide Description Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
Time Frame Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A1 Treatment A2q Treatment A2b Treatment R1 Treatment R3 Treatment R5
Hide Arm/Group Description:
Allopurinol 300 mg qd
Allopurinol 600 mg qd
Allopurinol 600 mg (300 mg bid)
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
Allopurinol 300 mg qd + RDEA3170 15 mg qd
Overall Number of Participants Analyzed 20 10 10 20 20 20
Mean (Standard Error)
Unit of Measure: Maximum Percentage (%) Change
-40.2  (3.29) -55.0  (4.96) -56.8  (4.52) -48.1  (2.91) -61.0  (2.59) -69.5  (2.09)
2.Primary Outcome
Title Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.
Hide Description Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
Time Frame Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A1 Treatment A2q Treatment A2b Treatment R1 Treatment R3 Treatment R5
Hide Arm/Group Description:
Allopurinol 300 mg qd
Allopurinol 600 mg qd
Allopurinol 600 mg (300 mg bid)
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
Allopurinol 300 mg qd + RDEA3170 15 mg qd
Overall Number of Participants Analyzed 20 10 10 20 20 20
Mean (Standard Error)
Unit of Measure: mg/dL
5.8  (0.24) 4.8  (0.38) 4.0  (0.39) 5.5  (0.24) 4.6  (0.22) 3.8  (0.18)
3.Primary Outcome
Title Cohort 1 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))
Hide Description Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
Time Frame Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A1 Treatment A2q Treatment A2b Treatment R1 Treatment R3 Treatment R5
Hide Arm/Group Description:
Allopurinol 300 mg qd
Allopurinol 600 mg qd
Allopurinol 600 mg (300 mg bid)
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
Allopurinol 300 mg qd + RDEA3170 15 mg qd
Overall Number of Participants Analyzed 20 10 10 20 20 20
Mean (Standard Error)
Unit of Measure: Percentage (%) Change
1065  (138) 1827  (252) 2633  (255) 899  (116) 958  (128) 827  (106)
4.Primary Outcome
Title Cohort 1 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))
Hide Description Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
Time Frame Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A1 Treatment A2q Treatment A2b Treatment R1 Treatment R3 Treatment R5
Hide Arm/Group Description:
Allopurinol 300 mg qd
Allopurinol 600 mg qd
Allopurinol 600 mg (300 mg bid)
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd
Allopurinol 300 mg qd + RDEA3170 15 mg qd
Overall Number of Participants Analyzed 20 10 10 20 20 20
Mean (Standard Error)
Unit of Measure: Percentage (%) Change
400  (74.6) 517  (106) 827  (136) 310  (55.5) 311  (51.8) 305  (54.7)
5.Primary Outcome
Title Cohort 2 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))
Hide Description Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)
Time Frame Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A1 Treatment A2q Treatment A2b Treatment R2 Treatment R4 Treatment R6
Hide Arm/Group Description:
Allopurinol 300 mg qd
Allopurinol 600 mg qd
Allopurinol 600 mg (300 mg bid)
Allopurinol 300 mg qd + RDEA3170 5 mg qd
Allopurinol 300 mg qd + RDEA3170 10 mg qd
Allopurinol 300 mg qd + RDEA3170 20 mg qd
Overall Number of Participants Analyzed 20 10 10 20 20 20
Mean (Standard Error)
Unit of Measure: Maximum Percentage (%) Change
-39.3  (1.78) -54.4  (4.50) -50.3  (4.15) -57.8  (1.61) -66.0  (1.86) -73.2  (1.75)
6.Primary Outcome
Title Cohort 2 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.
Hide Description Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)
Time Frame Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A1 Treatment A2q Treatment A2b Treatment R2 Treatment R4 Treatment R6
Hide Arm/Group Description:
Allopurinol 300 mg qd
Allopurinol 600 mg qd
Allopurinol 600 mg (300 mg bid)
Allopurinol 300 mg qd + RDEA3170 5 mg qd
Allopurinol 300 mg qd + RDEA3170 10 mg qd
Allopurinol 300 mg qd + RDEA3170 20 mg qd
Overall Number of Participants Analyzed 20 10 10 20 20 20
Mean (Standard Error)
Unit of Measure: mg/dL
6.2  (0.22) 5.0  (0.61) 4.6  (0.33) 4.8  (0.22) 4.1  (0.22) 3.5  (0.20)
7.Primary Outcome
Title Cohort 2 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))
Hide Description Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)
Time Frame Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A1 Treatment A2q Treatment A2b Treatment R2 Treatment R4 Treatment R6
Hide Arm/Group Description:
Allopurinol 300 mg qd
Allopurinol 600 mg qd
Allopurinol 600 mg (300 mg bid)
Allopurinol 300 mg qd + RDEA3170 5 mg qd
Allopurinol 300 mg qd + RDEA3170 10 mg qd
Allopurinol 300 mg qd + RDEA3170 20 mg qd
Overall Number of Participants Analyzed 20 10 10 20 20 20
Mean (Standard Error)
Unit of Measure: Percentage (%) Change
952  (77.2) 2027  (203) 2138  (164) 812  (76.3) 797  (65.7) 816  (71.1)
8.Primary Outcome
Title Cohort 2 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))
Hide Description Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)
Time Frame Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A1 Treatment A2q Treatment A2b Treatment R2 Treatment R4 Treatment R6
Hide Arm/Group Description:
Allopurinol 300 mg qd
Allopurinol 600 mg qd
Allopurinol 600 mg (300 mg bid)
Allopurinol 300 mg qd + RDEA3170 5 mg qd
Allopurinol 300 mg qd + RDEA3170 10 mg qd
Allopurinol 300 mg qd + RDEA3170 20 mg qd
Overall Number of Participants Analyzed 20 10 10 20 20 20
Mean (Standard Error)
Unit of Measure: Percentage (%) Change
372  (33.9) 645  (76.9) 681  (63.9) 268  (24.1) 267  (23.4) 286  (25.6)
9.Secondary Outcome
Title Maximum Observed Concentration (Cmax)
Hide Description Cmax of Allopurinol alone or in combination with RDEA3170
Time Frame Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A1 Treatment A2q Treatment A2b Treatment R1 Treatment R2 Treatment R3 Treatment R4 Treatment R5 Treatment R6
Hide Arm/Group Description:
Allopurinol 300 mg qd (Cohorts 1 and 2)
Allopurinol 600 mg (qd) (Cohorts 1 and 2)
Allopurinol 600 mg (300 mg bid) (Cohorts 1 and 2)
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd (Cohort 1)
Allopurinol 300 mg qd + RDEA3170 5 mg qd (Cohort 2)
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd (Cohort 1)
Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
Overall Number of Participants Analyzed 40 20 20 20 20 20 20 20 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
1.18
(1.03 to 1.36)
2.43
(1.94 to 3.04)
1.19
(0.997 to 1.42)
1.16
(0.911 to 1.47)
1.16
(0.937 to 1.43)
1.14
(0.905 to 1.44)
1.11
(0.928 to 1.33)
1.12
(0.877 to 1.44)
1.26
(1.02 to 1.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment A1, Treatment R1
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Informal BE assessment using the conventional BE limits of 80% to 125%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fixed effect for treatment and random effects for subjects.
Method of Estimation Estimation Parameter Geometric Least Squares Mean Ratio (%)
Estimated Value 103
Confidence Interval (2-Sided) 90%
90.7 to 117
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment A1, Treatment R2
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Informal BE assessment using the conventional BE limits of 80% to 125%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fixed effect for treatment and random effects for subjects.
Method of Estimation Estimation Parameter Geometric Least Squares Mean Ratio (%)
Estimated Value 92.6
Confidence Interval (2-Sided) 90%
78.1 to 110
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Treatment A1, Treatment R3
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Informal BE assessment using the conventional BE limits of 80% to 125%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
Method of Estimation Estimation Parameter Geometric Least Squares Mean Ratio (%)
Estimated Value 102
Confidence Interval (2-Sided) 90%
85.7 to 120
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Treatment A1, Treatment R4
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Informal BE assessment using the conventional BE limits of 80% to 125%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
Method of Estimation Estimation Parameter Geometric Least Squares Mean Ratio (%)
Estimated Value 88.9
Confidence Interval (2-Sided) 90%
78.4 to 101
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Treatment A1, Treatment R5
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Informal BE assessment using the conventional BE limits of 80% to 125%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale
Method of Estimation Estimation Parameter Geometric Least Squares Mean Ratio (%)
Estimated Value 100
Confidence Interval (2-Sided) 90%
87.7 to 114
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Treatment A1, Treatment R6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Informal BE assessment using the conventional BE limits of 80% to 125%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
Method of Estimation Estimation Parameter Geometric Least Squares Mean Ratio (%)
Estimated Value 101
Confidence Interval (2-Sided) 90%
85.5 to 119
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Time of Occurrence of Maximum Observed Concentration (Tmax)
Hide Description Tmax of Allopurinol alone or in combination with RDEA3170
Time Frame Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A1 Treatment A2q Treatment A2b Treatment R1 Treatment R2 Treatment R3 Treatment R4 Treatment R5 Treatment R6
Hide Arm/Group Description:
Allopurinol 300 mg qd (Cohorts 1 and 2)
Allopurinol 600 mg (qd) (Cohorts 1 and 2)
Allopurinol 600 mg (300 mg bid) (Cohorts 1 and 2)
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd (Cohort 1)
Allopurinol 300 mg qd + RDEA3170 5 mg qd (Cohort 2)
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd (Cohort 1)
Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
Overall Number of Participants Analyzed 40 20 20 20 20 20 20 20 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: hr
1.50
(0.500 to 6.02)
2.98
(0.983 to 4.00)
2.02
(0.500 to 8.00)
2.01
(0.967 to 6.00)
2.49
(0.500 to 3.97)
1.73
(0.500 to 6.00)
2.98
(0.500 to 6.02)
1.73
(0.500 to 6.00)
1.97
(0.500 to 4.03)
11.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 Allopurinol alone or in combination with RDEA3170
Time Frame Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A1 Treatment A2q Treatment A2b Treatment R1 Treatment R2 Treatment R3 Treatment R4 Treatment R5 Treatment R6
Hide Arm/Group Description:
Allopurinol 300 mg qd (Cohorts 1 and 2)
Allopurinol 600 mg (qd) (Cohorts 1 and 2)
Allopurinol 600 mg (300 mg bid) (Cohorts 1 and 2)
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd (Cohort 1)
Allopurinol 300 mg qd + RDEA3170 5 mg qd (Cohort 2)
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd (Cohort 1)
Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
Overall Number of Participants Analyzed 40 20 20 20 20 20 20 20 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg·hr/mL
3.94
(3.52 to 4.42)
11.0
(8.87 to 13.7)
8.64
(7.13 to 10.5)
4.06
(3.24 to 5.10)
4.10
(3.53 to 4.77)
3.81
(3.13 to 4.64)
3.83
(3.15 to 4.65)
3.88
(3.15 to 4.77)
3.82
(3.27 to 4.46)
12.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 Allopurinol alone or in combination with RDEA3170
Time Frame Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A1 Treatment A2q Treatment A2b Treatment R1 Treatment R2 Treatment R3 Treatment R4 Treatment R5 Treatment R6
Hide Arm/Group Description:
Allopurinol 300 mg qd (Cohorts 1 and 2)
Allopurinol 600 mg (qd) (Cohorts 1 and 2)
Allopurinol 600 mg (300 mg bid) (Cohorts 1 and 2)
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd (Cohort 1)
Allopurinol 300 mg qd + RDEA3170 5 mg qd (Cohort 2)
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd (Cohort 1)
Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
Overall Number of Participants Analyzed 40 20 20 20 20 20 20 20 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg·hr/mL
3.70
(3.28 to 4.18)
10.9
(8.74 to 13.5)
4.25
(3.57 to 5.07)
3.59
(2.87 to 4.49)
3.76
(3.20 to 4.41)
3.71
(3.04 to 4.54)
3.53
(2.84 to 4.39)
3.74
(3.21 to 4.34)
3.74
(3.21 to 4.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment A1, Treatment R1
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Informal BE assessment using the conventional BE limits of 80% to 125%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
Method of Estimation Estimation Parameter Geometric Least Squares Mean Ratio (%)
Estimated Value 100
Confidence Interval (2-Sided) 90%
94.3 to 107
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment A1, Treatment R2
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Informal BE assessment using the conventional BE limits of 80% to 125%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
Method of Estimation Estimation Parameter Geometric Least Squares Mean Ratio (%)
Estimated Value 98.0
Confidence Interval (2-Sided) 90%
90.4 to 106
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Treatment A1, Treatment R3
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Informal BE assessment using the conventional BE limits of 80% to 125%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
Method of Estimation Estimation Parameter Geometric Least Squares Mean Ratio (%)
Estimated Value 104
Confidence Interval (2-Sided) 90%
94.5 to 114
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Treatment A1, Treatment R4
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Informal BE assessment using the conventional BE limits of 80% to 125%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
Method of Estimation Estimation Parameter Geometric Least Squares Mean Ratio (%)
Estimated Value 92.0
Confidence Interval (2-Sided) 90%
86.7 to 97.7
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Treatment A1, Treatment R5
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Informal BE assessment using the conventional BE limits of 80% to 125%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
Method of Estimation Estimation Parameter Geometric Least Squares Mean Ratio (%)
Estimated Value 98.9
Confidence Interval (2-Sided) 90%
91.0 to 107
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Treatment A1, Treatment R6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Informal BE assessment using the conventional BE limits of 80% to 125%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
Method of Estimation Estimation Parameter Geometric Least Squares Mean Ratio (%)
Estimated Value 97.5
Confidence Interval (2-Sided) 90%
92.8 to 102
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Apparent Terminal Half-life (t1/2)
Hide Description t1/2 of Allopurinol alone or in combination with RDEA3170
Time Frame Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A1 Treatment A2q Treatment A2b Treatment R1 Treatment R2 Treatment R3 Treatment R4 Treatment R5 Treatment R6
Hide Arm/Group Description:
Allopurinol 300 mg qd (Cohorts 1 and 2)
Allopurinol 600 mg (qd) (Cohorts 1 and 2)
Allopurinol 600 mg (300 mg bid) (Cohorts 1 and 2)
Allopurinol 300 mg qd + RDEA3170 2.5 mg qd (Cohort 1)
Allopurinol 300 mg qd + RDEA3170 5 mg qd (Cohort 2)
Allopurinol 300 mg qd + RDEA3170 7.5 mg qd (Cohort 1)
Allopurinol 300 mg qd + RDEA3170 10 mg qd (Cohort 2)
Allopurinol 300 mg qd + RDEA3170 15 mg qd (Cohort 1)
Allopurinol 300 mg qd + RDEA3170 20 mg qd (Cohort 2)
Overall Number of Participants Analyzed 40 20 20 20 20 20 20 20 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: hr
1.21
(1.14 to 1.27)
1.47
(1.33 to 1.62)
1.25
(1.13 to 1.38)
1.20
(1.10 to 1.30)
1.14
(1.03 to 1.25)
1.17
(1.10 to 1.25)
1.16
(1.08 to 1.24)
1.13
(1.04 to 1.22)
1.13
(1.03 to 1.24)
14.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events
Hide Description [Not Specified]
Time Frame 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:
RDEA3170 2.5 mg, 7.5 mg and 15 mg qd in combination with allopurinol 300 mg (qd and bid)
RDEA3170 5 mg, 10 mg 20 mg qd in combination with allopurinol 300 mg (qd and bid)
Overall Number of Participants Analyzed 20 21
Measure Type: Number
Unit of Measure: Number of participants
6 6
Time Frame 11 Weeks.
Adverse Event Reporting Description 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.
 
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description RDEA3170 2.5 mg, 7.5 mg and 15 mg qd in combination with allopurinol 300 mg (qd and bid) RDEA3170 5 mg, 10 mg 20 mg qd in combination with allopurinol 300 mg (qd and bid)
All-Cause Mortality
Cohort 1 Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1 Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      0/21 (0.00%)    
Respiratory, thoracic and mediastinal disorders     
Pneumonia Aspiration  1  1/20 (5.00%)  1 0/21 (0.00%)  0
1
Term from vocabulary, MedDRA Version 17.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/20 (30.00%)      6/21 (28.57%)    
Gastrointestinal disorders     
Toothache  1  1/20 (5.00%)  1 0/21 (0.00%)  0
General disorders     
Pyrexia  1  1/20 (5.00%)  1 0/21 (0.00%)  0
Immune system disorders     
Seasonal Allergy  1  1/20 (5.00%)  1 0/21 (0.00%)  0
Infections and infestations     
Upper Respiratory Tract Infection  1  2/20 (10.00%)  2 2/21 (9.52%)  2
Sinusitis  1  1/20 (5.00%)  1 0/21 (0.00%)  0
Injury, poisoning and procedural complications     
Arthropod Bite  1  0/20 (0.00%)  0 1/21 (4.76%)  1
Excoriation  1  0/20 (0.00%)  0 1/21 (4.76%)  1
Musculoskeletal and connective tissue disorders     
Musculoskeletal Pain  1  0/20 (0.00%)  0 2/21 (9.52%)  2
Neck Pain  1  0/20 (0.00%)  0 1/21 (4.76%)  1
Nervous system disorders     
Headache  1  0/20 (0.00%)  0 3/21 (14.29%)  3
Renal and urinary disorders     
Renal Failure Acute  1  1/20 (5.00%)  1 0/21 (0.00%)  0
Reproductive system and breast disorders     
Erectile Dysfunction  1  0/20 (0.00%)  0 1/21 (4.76%)  1
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  1/20 (5.00%)  2 0/21 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis  1  1/20 (5.00%)  1 0/21 (0.00%)  0
1
Term from vocabulary, MedDRA Version 17.0
Indicates events were collected by systematic assessment
Reliable urine uric acid values were not obtained due to sample processing errors, and this has resulted in the inability to assess the PD effects of RDEA3170 and/or allopurinol in urine.
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
Layout table for Results Point of Contact information
Name/Title: Jesse Hall, MD
Organization: Study Information Center AstraZeneca
Phone: (877) 240-9479
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02498652     History of Changes
Other Study ID Numbers: RDEA3170-206
First Submitted: July 13, 2015
First Posted: July 15, 2015
Results First Submitted: July 17, 2017
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018