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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: NCT02279641
Recruitment Status : Completed
First Posted : October 31, 2014
Results First Posted : December 20, 2017
Last Update Posted : December 20, 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: Basic Science
Condition Gout
Interventions Drug: RDEA3170 10 mg
Drug: allopurinol 300 mg
Enrollment 12
Recruitment Details 12 subjects were randomized
Pre-assignment Details Twelve subjects were randomized to 1 of 2 treatment sequences (Sequence A or B) in a 1:1 ratio.
Arm/Group Title RDEA3170 or Allopurinol Alone and in Combination (Sequence A) RDEA3170 or Allopurinol Alone and in Combination (Sequence B)
Hide Arm/Group Description Days 1 to 7: 10 mg once daily (qd) RDEA3170; Days 8 to 14: 10 mg qd RDEA3170 + 300 mg qd allopurinol; Days 15 to 21: 300 mg qd allopurinol Days 1 to 7: 300 mg qd allopurinol; Days 8 to 14: 10 mg qd RDEA3170 + 300 mg qd allopurinol; Days 15 to 21: 10 mg qd RDEA3170
Period Title: Overall Study
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title Sequence A Sequence B Total
Hide Arm/Group Description Days 1 to 7: 10 mg once daily (qd) RDEA3170; Days 8 to 14: 10 mg qd RDEA3170 + 300 mg qd allopurinol; Days 15 to 21: 300 mg qd allopurinol Days 1 to 7: 300 mg qd allopurinol; Days 8 to 14: 10 mg qd RDEA3170 + 300 mg qd allopurinol; Days 15 to 21: 10 mg qd RDEA3170 Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
53  (10.1) 49  (10.4) 51  (10.0)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
<65 6 6 12
>=65 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
6
 100.0%
6
 100.0%
12
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 12 participants
6 6 12
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description Cmax of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Time Frame 22 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allopurinol: Allopurinol Alone Allopurinol: RDEA3170 + Allopurinol Oxypurinol: Allopurinol Alone Oxypurinol: RDEA3170 + Allopurinol
Hide Arm/Group Description:
Allopurinol 300 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Allopurinol 300 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Overall Number of Participants Analyzed 12 12 12 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
1.13
(0.894 to 1.43)
1.51
(1.24 to 1.82)
12.8
(11.7 to 14.0)
8.68
(7.99 to 9.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allopurinol: Allopurinol Alone, Allopurinol: RDEA3170 + Allopurinol
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 133
Confidence Interval (2-Sided) 90%
111 to 159
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oxypurinol: Allopurinol Alone, Oxypurinol: RDEA3170 + Allopurinol
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 67.9
Confidence Interval (2-Sided) 90%
65.2 to 70.7
Estimation Comments [Not Specified]
2.Primary Outcome
Title Time of Occurrence of Maximum Observed Concentration (Tmax)
Hide Description Tmax of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Time Frame 22 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allopurinol: Allopurinol Alone Allopurinol: RDEA3170 + Allopurinol Oxypurinol: Allopurinol Alone Oxypurinol: RDEA3170 + Allopurinol RDEA3170: RDEA3170 Alone RDEA3170: RDEA3170 + Allopurinol
Hide Arm/Group Description:
Allopurinol 300 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Allopurinol 300 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
RDEA3170 10 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Overall Number of Participants Analyzed 12 12 12 12 12 12
Median (Full Range)
Unit of Measure: hr
1.50
(1.00 to 4.00)
1.25
(0.500 to 4.00)
4.00
(1.50 to 6.00)
3.50
(1.50 to 8.00)
3.00
(1.50 to 4.00)
3.00
(2.00 to 10.0)
3.Primary 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/Oxypurinol Alone and In Combination with RDEA3170
Time Frame 22 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allopurinol: Allopurinol Alone Allopurinol: RDEA3170 + Allopurinol Oxypurinol: Allopurinol Alone Oxypurinol: RDEA3170 + Allopurinol RDEA3170: RDEA3170 + Allopurinol
Hide Arm/Group Description:
Allopurinol 300 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Allopurinol 300 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Overall Number of Participants Analyzed 12 12 12 12 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg·hr/mL
3.69
(3.24 to 4.21)
3.68
(3.28 to 4.13)
255
(229 to 284)
157
(140 to 177)
115
(96.5 to 137)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allopurinol: Allopurinol Alone, Allopurinol: RDEA3170 + Allopurinol
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%
93.3 to 111
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oxypurinol: Allopurinol Alone, Oxypurinol: RDEA3170 + Allopurinol
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 61.8
Confidence Interval (2-Sided) 90%
58.1 to 65.7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RDEA3170: RDEA3170 + Allopurinol
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 95.9
Confidence Interval (2-Sided) 90%
88.4 to 104
Estimation Comments [Not Specified]
4.Primary 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/Oxypurinol Alone and In Combination with RDEA3170
Time Frame 22 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allopurinol: Allopurinol Alone Allopurinol: RDEA3170 + Allopurinol Oxypurinol: Allopurinol Alone Oxypurinol: RDEA3170 + Allopurinol
Hide Arm/Group Description:
Allopurinol 300 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Allopurinol 300 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Overall Number of Participants Analyzed 12 12 12 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg·hr/mL
3.50
(3.04 to 4.04)
3.61
(3.22 to 4.05)
255
(229 to 284)
157
(140 to 177)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allopurinol: Allopurinol Alone, Allopurinol: RDEA3170 + Allopurinol
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 103
Confidence Interval (2-Sided) 90%
94.9 to 112
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oxypurinol: Allopurinol Alone, Oxypurinol: RDEA3170 + Allopurinol
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 61.8
Confidence Interval (2-Sided) 90%
58.1 to 65.7
Estimation Comments [Not Specified]
5.Primary Outcome
Title Apparent Terminal Half-life (t1/2)
Hide Description t1/2 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Time Frame 22 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allopurinol: Allopurinol Alone Allopurinol: RDEA3170 + Allopurinol Oxypurinol: Allopurinol Alone Oxypurinol: RDEA3170 + Allopurinol RDEA3170: RDEA3170 Alone RDEA3170: RDEA3170 + Allopurinol
Hide Arm/Group Description:
Allopurinol 300 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Allopurinol 300 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
RDEA3170 10 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Overall Number of Participants Analyzed 12 12 12 12 12 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: hr
1.06
(0.969 to 1.15)
0.992
(0.890 to 1.10)
43.2
(36.1 to 51.7)
29.1
(23.9 to 35.4)
11.5
(8.43 to 15.6)
12.5
(8.99 to 17.4)
6.Primary Outcome
Title Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
Hide Description Ae0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Time Frame 22 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allopurinol: Allopurinol Alone Allopurinol: RDEA3170 + Allopurinol Oxypurinol: Allopurinol Alone Oxypurinol: RDEA3170 + Allopurinol
Hide Arm/Group Description:
Allopurinol 300 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Allopurinol 300 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Overall Number of Participants Analyzed 12 12 12 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg
25.4
(22.1 to 29.2)
22.7
(19.2 to 26.9)
231
(216 to 248)
275
(262 to 290)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allopurinol: Allopurinol Alone, Allopurinol: RDEA3170 + Allopurinol
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 89.5
Confidence Interval (2-Sided) 90%
81.8 to 98.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oxypurinol: Allopurinol Alone, Oxypurinol: RDEA3170 + Allopurinol
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 119
Confidence Interval (2-Sided) 90%
114 to 125
Estimation Comments [Not Specified]
7.Primary Outcome
Title Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24)
Hide Description CLR0-24 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Time Frame 22 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allopurinol: Allopurinol Alone Allopurinol: RDEA3170 + Allopurinol Oxypurinol: Allopurinol Alone Oxypurinol: RDEA3170 + Allopurinol RDEA3170: RDEA3170 Alone RDEA3170: RDEA3170 + Allopurinol
Hide Arm/Group Description:
Allopurinol 300 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Allopurinol 300 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
RDEA3170 10 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Overall Number of Participants Analyzed 12 12 12 12 12 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: mL/min
120
(106 to 135)
103
(87.1 to 122)
15.1
(13.0 to 17.6)
29.2
(25.1 to 33.9)
9.28
(7.43 to 11.6)
9.75
(7.73 to 12.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allopurinol: Allopurinol Alone, Allopurinol: RDEA3170 + Allopurinol
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 87.5
Confidence Interval (2-Sided) 90%
79.3 to 96.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oxypurinol: Allopurinol Alone, Oxypurinol: RDEA3170 + Allopurinol
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 193
Confidence Interval (2-Sided) 90%
177 to 210
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RDEA3170: RDEA3170 Alone, RDEA3170: RDEA3170 + Allopurinol
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 105
Confidence Interval (2-Sided) 90%
94.4 to 117
Estimation Comments [Not Specified]
8.Primary Outcome
Title Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine
Hide Description [Not Specified]
Time Frame 22 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RDEA3170: RDEA3170 Alone Oxypurinol: RDEA3170 + Allopurinol Allopurinol: Allopurinol Alone
Hide Arm/Group Description:
RDEA3170 10 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Allopurinol 300 mg qd
Overall Number of Participants Analyzed 12 12 12
Mean (Standard Error)
Unit of Measure: Percentage (%)
Serum Urate Maximum % Change -50.5  (2.43) -65.2  (1.57) -43.0  (1.57)
Urine Uric Acid % Change (0-24h) 9.88  (7.61) -21.6  (5.58) -47.4  (2.67)
Renal Clearance of Uric Acid % Change (0-24h) 122  (46.8) 125  (42.2) -8.50  (6.04)
Fract. Excretion of Uric Acid % Change (0-24h) 77.4  (18.0) 78.4  (21.9) -12.0  (5.46)
9.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description Cmax of RDEA3170 Alone and In Combination with Allopurinol
Time Frame 22 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RDEA3170: RDEA3170 Alone RDEA3170: RDEA3170 + Allopurinol
Hide Arm/Group Description:
RDEA3170 10 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Overall Number of Participants Analyzed 12 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL
14.6
(12.2 to 17.5)
14.5
(11.7 to 17.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RDEA3170: RDEA3170 Alone, RDEA3170: RDEA3170 + Allopurinol
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 98.7
Confidence Interval (2-Sided) 95%
87.7 to 111
Estimation Comments [Not Specified]
10.Primary 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 RDEA3170 Alone and In Combination with Allopurinol
Time Frame 22 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RDEA3170: RDEA3170 Alone RDEA3170: RDEA3170 + Allopurinol
Hide Arm/Group Description:
RDEA3170 10 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Overall Number of Participants Analyzed 12 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg*hr/mL
120
(98.1 to 147)
115
(96.5 to 137)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RDEA3170: RDEA3170 + Allopurinol
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 95.9
Confidence Interval (2-Sided) 95%
88.4 to 104
Estimation Comments [Not Specified]
11.Primary Outcome
Title Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
Hide Description AUC last of RDEA3170 Alone and In Combination with Allopurinol
Time Frame 22 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RDEA3170: RDEA3170 Alone RDEA3170: RDEA3170 + Allopurinol
Hide Arm/Group Description:
RDEA3170 10 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Overall Number of Participants Analyzed 12 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng·hr/mL
120
(98.1 to 147)
115
(96.5 to 137)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RDEA3170: RDEA3170 Alone, RDEA3170: RDEA3170 + Allopurinol
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 95.9
Confidence Interval (2-Sided) 95%
88.4 to 104
Estimation Comments [Not Specified]
12.Primary Outcome
Title Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
Hide Description Ae0-24 of RDEA3170 Alone and In Combination with Allopurinol
Time Frame 22 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RDEA3170: RDEA3170 Alone RDEA3170: RDEA3170 + Allopurinol
Hide Arm/Group Description:
RDEA3170 10 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Overall Number of Participants Analyzed 12 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: ug
66.8
(51.8 to 86.1)
67.2
(51.7 to 87.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RDEA3170: RDEA3170 Alone, RDEA3170: RDEA3170 + Allopurinol
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) 95%
86.7 to 117
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Incidence of Treatment-Emergent Adverse Events
Hide Description [Not Specified]
Time Frame 22 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RDEA3170: RDEA3170 Alone Oxypurinol: RDEA3170 + Allopurinol Allopurinol: Allopurinol Alone
Hide Arm/Group Description:
RDEA3170 10 mg qd
RDEA3170 10 mg qd + Allopurinol 300 mg qd
Allopurinol 300 mg qd
Overall Number of Participants Analyzed 12 12 12
Measure Type: Number
Unit of Measure: Number of participants
2 1 3
Time Frame 22 days
Adverse Event Reporting Description Overall number of baseline participants used to determine number of participants at risk.
 
Arm/Group Title RDEA3170 10 mg qd RDEA3170 10 mg qd + Allopurinol 300 mg qd Allopurinol 300 mg qd
Hide Arm/Group Description RDEA3170 10 mg qd RDEA3170 10 mg qd + Allopurinol 300 mg qd Allopurinol 300 mg qd
All-Cause Mortality
RDEA3170 10 mg qd RDEA3170 10 mg qd + Allopurinol 300 mg qd Allopurinol 300 mg qd
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
RDEA3170 10 mg qd RDEA3170 10 mg qd + Allopurinol 300 mg qd Allopurinol 300 mg qd
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
RDEA3170 10 mg qd RDEA3170 10 mg qd + Allopurinol 300 mg qd Allopurinol 300 mg qd
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/12 (16.67%)      1/12 (8.33%)      3/12 (25.00%)    
Gastrointestinal disorders       
Diarrhoea  1  1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Toothache  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Vomiting  1  1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Infections and infestations       
Gastroenteritis  1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Nasopharyngitis  1  1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Nervous system disorders       
Dizziness  1  1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Headache  1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Skin and subcutaneous tissue disorders       
Petechiae  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Rash  1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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: +1 877-240-9479
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02279641     History of Changes
Other Study ID Numbers: RDEA3170-107
First Submitted: October 28, 2014
First Posted: October 31, 2014
Results First Submitted: March 14, 2017
Results First Posted: December 20, 2017
Last Update Posted: December 20, 2017