Trial Outcomes & Findings for Mild, Moderate and Severe Renal Impairment Study (NCT NCT02219516)
NCT ID: NCT02219516
Last Updated: 2017-04-25
Results Overview
AUC∞ following a single administration of RDEA3170 to subjects with various degrees of renal function
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Results posted on
2017-04-25
Participant Flow
31 subjects were randomized
Thirty-one subjects were randomized to 1 of 4 cohorts. Cohort 1: mild renal impairment; Cohort 2: moderate renal impairment; Cohort 3: severe renal impairment and Cohort 4: normal renal function. All 31 subjects received a single dose of 15 mg RDEA3170 (6 x 2.5 mg) in the fasted state.
Participant milestones
| Measure |
Cohort 1: Mild Renal Impairment + RDEA3170 15 mg
Mild Renal Impairment (eCrCl of 60 to \< 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
|
Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg
Moderate Renal Impairment (eCrCl of 30 to \< 60 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 3: Severe Renal Impairment + RDEA3170 15 mg
Severe Renal Impairment (eCrCl of 15 to \< 30 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 4: Normal Renal Function + RDEA3170 15 mg
Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
7
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mild, Moderate and Severe Renal Impairment Study
Baseline characteristics by cohort
| Measure |
Cohort 1: Mild Renal Impairment + RDEA3170 15 mg
n=8 Participants
Mild Renal Impairment (eCrCl of 60 to \< 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
|
Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg
n=8 Participants
Moderate Renal Impairment (eCrCl of 30 to \< 60 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 3: Severe Renal Impairment + RDEA3170 15 mg
n=7 Participants
Severe Renal Impairment (eCrCl of 15 to \< 30 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 4: Normal Renal Function + RDEA3170 15 mg
n=8 Participants
Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63 Years
STANDARD_DEVIATION 6.4 • n=39 Participants
|
67 Years
STANDARD_DEVIATION 14.9 • n=41 Participants
|
58 Years
STANDARD_DEVIATION 11.1 • n=35 Participants
|
56 Years
STANDARD_DEVIATION 4.7 • n=31 Participants
|
61 Years
STANDARD_DEVIATION 9.3 • n=146 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
31 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
31 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdoseCmax following a single administration of RDEA3170 to subjects with various degrees of renal function
Outcome measures
| Measure |
Cohort 1: Mild Renal Impairment + RDEA3170 15 mg
n=8 Participants
Mild Renal Impairment (eCrCl of 60 to \< 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
|
Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg
n=8 Participants
Moderate Renal Impairment (eCrCl of 30 to \< 60 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 3: Severe Renal Impairment + RDEA3170 15 mg
n=7 Participants
Severe Renal Impairment (eCrCl of 15 to \< 30 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 4: Normal Renal Function + RDEA3170 15 mg
n=8 Participants
Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
25.6 ng/mL
Interval 20.0 to 32.9
|
29.0 ng/mL
Interval 22.8 to 37.0
|
38.2 ng/mL
Interval 24.0 to 60.8
|
16.7 ng/mL
Interval 12.6 to 22.3
|
PRIMARY outcome
Timeframe: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdoseTmax following a single administration of RDEA3170 to subjects with various degrees of renal function
Outcome measures
| Measure |
Cohort 1: Mild Renal Impairment + RDEA3170 15 mg
n=8 Participants
Mild Renal Impairment (eCrCl of 60 to \< 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
|
Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg
n=8 Participants
Moderate Renal Impairment (eCrCl of 30 to \< 60 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 3: Severe Renal Impairment + RDEA3170 15 mg
n=7 Participants
Severe Renal Impairment (eCrCl of 15 to \< 30 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 4: Normal Renal Function + RDEA3170 15 mg
n=8 Participants
Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
|
|---|---|---|---|---|
|
Time of Occurrence of Maximum Observed Concentration (Tmax)
|
2.50 hr
Interval 1.0 to 4.0
|
3.00 hr
Interval 1.5 to 5.0
|
2.00 hr
Interval 1.5 to 4.0
|
2.50 hr
Interval 0.5 to 4.0
|
PRIMARY outcome
Timeframe: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdoseAUC last following a single administration of RDEA3170 to subjects with various degrees of renal function
Outcome measures
| Measure |
Cohort 1: Mild Renal Impairment + RDEA3170 15 mg
n=8 Participants
Mild Renal Impairment (eCrCl of 60 to \< 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
|
Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg
n=8 Participants
Moderate Renal Impairment (eCrCl of 30 to \< 60 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 3: Severe Renal Impairment + RDEA3170 15 mg
n=7 Participants
Severe Renal Impairment (eCrCl of 15 to \< 30 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 4: Normal Renal Function + RDEA3170 15 mg
n=8 Participants
Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
|
197 ng.hr/mL
Interval 142.0 to 273.0
|
333 ng.hr/mL
Interval 246.0 to 451.0
|
316 ng.hr/mL
Interval 179.0 to 559.0
|
150 ng.hr/mL
Interval 123.0 to 182.0
|
PRIMARY outcome
Timeframe: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdoseAUC∞ following a single administration of RDEA3170 to subjects with various degrees of renal function
Outcome measures
| Measure |
Cohort 1: Mild Renal Impairment + RDEA3170 15 mg
n=8 Participants
Mild Renal Impairment (eCrCl of 60 to \< 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
|
Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg
n=8 Participants
Moderate Renal Impairment (eCrCl of 30 to \< 60 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 3: Severe Renal Impairment + RDEA3170 15 mg
n=7 Participants
Severe Renal Impairment (eCrCl of 15 to \< 30 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 4: Normal Renal Function + RDEA3170 15 mg
n=8 Participants
Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞)
|
201 ng.hr/mL
Interval 144.0 to 279.0
|
402 ng.hr/mL
Interval 225.0 to 634.0
|
372 ng.hr/mL
Interval 209.0 to 663.0
|
162 ng.hr/mL
Interval 120.0 to 218.0
|
PRIMARY outcome
Timeframe: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdoset1/2 following a single administration of RDEA3170 to subjects with various degrees of renal function
Outcome measures
| Measure |
Cohort 1: Mild Renal Impairment + RDEA3170 15 mg
n=8 Participants
Mild Renal Impairment (eCrCl of 60 to \< 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
|
Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg
n=8 Participants
Moderate Renal Impairment (eCrCl of 30 to \< 60 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 3: Severe Renal Impairment + RDEA3170 15 mg
n=7 Participants
Severe Renal Impairment (eCrCl of 15 to \< 30 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 4: Normal Renal Function + RDEA3170 15 mg
n=8 Participants
Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
|
|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2)
|
9.53 hr
Interval 7.42 to 12.2
|
20.6 hr
Interval 9.96 to 42.4
|
22.0 hr
Interval 14.2 to 34.1
|
13.0 hr
Interval 7.91 to 21.5
|
PRIMARY outcome
Timeframe: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdoseCLNR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function
Outcome measures
| Measure |
Cohort 1: Mild Renal Impairment + RDEA3170 15 mg
n=8 Participants
Mild Renal Impairment (eCrCl of 60 to \< 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
|
Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg
n=8 Participants
Moderate Renal Impairment (eCrCl of 30 to \< 60 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 3: Severe Renal Impairment + RDEA3170 15 mg
n=7 Participants
Severe Renal Impairment (eCrCl of 15 to \< 30 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 4: Normal Renal Function + RDEA3170 15 mg
n=8 Participants
Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
|
|---|---|---|---|---|
|
Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72)
|
74.9 L/hr
Interval 53.9 to 104.0
|
44.5 L/hr
Interval 33.0 to 59.9
|
47.2 L/hr
Interval 26.6 to 83.5
|
98.6 L/hr
Interval 80.9 to 120.0
|
PRIMARY outcome
Timeframe: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdoseCL/F following a single administration of RDEA3170 to subjects with various degrees of renal function
Outcome measures
| Measure |
Cohort 1: Mild Renal Impairment + RDEA3170 15 mg
n=8 Participants
Mild Renal Impairment (eCrCl of 60 to \< 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
|
Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg
n=8 Participants
Moderate Renal Impairment (eCrCl of 30 to \< 60 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 3: Severe Renal Impairment + RDEA3170 15 mg
n=7 Participants
Severe Renal Impairment (eCrCl of 15 to \< 30 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 4: Normal Renal Function + RDEA3170 15 mg
n=8 Participants
Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
|
|---|---|---|---|---|
|
Total Body Clearance Corrected for Bioavailability (CL/F)
|
74.8 L/hr
Interval 53.7 to 104.0
|
37.3 L/hr
Interval 23.7 to 58.9
|
40.3 L/hr
Interval 22.6 to 71.7
|
92.6 L/hr
Interval 68.7 to 125.0
|
PRIMARY outcome
Timeframe: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdoseCLR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function
Outcome measures
| Measure |
Cohort 1: Mild Renal Impairment + RDEA3170 15 mg
n=8 Participants
Mild Renal Impairment (eCrCl of 60 to \< 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
|
Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg
n=8 Participants
Moderate Renal Impairment (eCrCl of 30 to \< 60 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 3: Severe Renal Impairment + RDEA3170 15 mg
n=7 Participants
Severe Renal Impairment (eCrCl of 15 to \< 30 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 4: Normal Renal Function + RDEA3170 15 mg
n=8 Participants
Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
|
|---|---|---|---|---|
|
Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72)
|
12.9 mL/min
Interval 8.16 to 20.4
|
7.87 mL/min
Interval 3.36 to 18.4
|
2.86 mL/min
Interval 1.84 to 4.45
|
13.5 mL/min
Interval 9.03 to 20.2
|
SECONDARY outcome
Timeframe: 5 weeksOutcome measures
| Measure |
Cohort 1: Mild Renal Impairment + RDEA3170 15 mg
n=8 Participants
Mild Renal Impairment (eCrCl of 60 to \< 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
|
Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg
n=8 Participants
Moderate Renal Impairment (eCrCl of 30 to \< 60 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 3: Severe Renal Impairment + RDEA3170 15 mg
n=7 Participants
Severe Renal Impairment (eCrCl of 15 to \< 30 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 4: Normal Renal Function + RDEA3170 15 mg
n=8 Participants
Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
|
|---|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events
|
3 Number of participants
|
1 Number of participants
|
2 Number of participants
|
1 Number of participants
|
SECONDARY outcome
Timeframe: Screening, Day -1 ( -24, -21, -18, -and -12 hours predose), and Day 1 (within 30 minutes prior to dosing and at 3, 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours postdose)Outcome measures
| Measure |
Cohort 1: Mild Renal Impairment + RDEA3170 15 mg
n=8 Participants
Mild Renal Impairment (eCrCl of 60 to \< 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
|
Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg
n=8 Participants
Moderate Renal Impairment (eCrCl of 30 to \< 60 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 3: Severe Renal Impairment + RDEA3170 15 mg
n=7 Participants
Severe Renal Impairment (eCrCl of 15 to \< 30 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 4: Normal Renal Function + RDEA3170 15 mg
n=8 Participants
Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
|
|---|---|---|---|---|
|
Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine
Serum Urate Maximum % Change
|
-36.9 Maximum Percentage (%) Change
Standard Error 4.79
|
-20.5 Maximum Percentage (%) Change
Standard Error 2.62
|
-12.6 Maximum Percentage (%) Change
Standard Error 2.62
|
-38.3 Maximum Percentage (%) Change
Standard Error 5.24
|
|
Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine
Urine Uric Acid % Change (0-24h)
|
118 Maximum Percentage (%) Change
Standard Error 25.3
|
69.3 Maximum Percentage (%) Change
Standard Error 19.0
|
72.5 Maximum Percentage (%) Change
Standard Error 17.1
|
85.2 Maximum Percentage (%) Change
Standard Error 15.2
|
|
Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine
Renal Clearance of Uric Acid % Change (0-24h)
|
222 Maximum Percentage (%) Change
Standard Error 50.5
|
96.7 Maximum Percentage (%) Change
Standard Error 11.9
|
82.9 Maximum Percentage (%) Change
Standard Error 16.6
|
163 Maximum Percentage (%) Change
Standard Error 30.1
|
|
Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine
Fract. Excretion of Uric Acid % Change (0-24h)
|
206 Maximum Percentage (%) Change
Standard Error 44.9
|
89.6 Maximum Percentage (%) Change
Standard Error 24.1
|
54.5 Maximum Percentage (%) Change
Standard Error 17.0
|
159 Maximum Percentage (%) Change
Standard Error 28.7
|
|
Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine
Urine Uric Acid % Change (24-48h)
|
-9.49 Maximum Percentage (%) Change
Standard Error 6.68
|
4.18 Maximum Percentage (%) Change
Standard Error 9.89
|
28.3 Maximum Percentage (%) Change
Standard Error 11.2
|
-1.54 Maximum Percentage (%) Change
Standard Error 12.1
|
|
Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine
Urine Uric Acid % Change (48-72h)
|
-23.1 Maximum Percentage (%) Change
Standard Error 7.63
|
-16.0 Maximum Percentage (%) Change
Standard Error 11.5
|
6.02 Maximum Percentage (%) Change
Standard Error 20.2
|
-20.8 Maximum Percentage (%) Change
Standard Error 9.65
|
|
Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine
Renal Clearance of Uric Acid % Change (24-48h)
|
42.1 Maximum Percentage (%) Change
Standard Error 12.9
|
25.4 Maximum Percentage (%) Change
Standard Error 9.40
|
34.5 Maximum Percentage (%) Change
Standard Error 9.17
|
31.9 Maximum Percentage (%) Change
Standard Error 16.8
|
|
Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine
Renal Clearance of Uric Acid % Change (48-72h)
|
2.39 Maximum Percentage (%) Change
Standard Error 6.84
|
-0.439 Maximum Percentage (%) Change
Standard Error 11.9
|
9.38 Maximum Percentage (%) Change
Standard Error 21.5
|
-8.12 Maximum Percentage (%) Change
Standard Error 12.2
|
|
Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine
Fract. Excretion of Uric Acid % Change (24-48h)
|
39.2 Maximum Percentage (%) Change
Standard Error 10.8
|
28.7 Maximum Percentage (%) Change
Standard Error 7.91
|
19.0 Maximum Percentage (%) Change
Standard Error 4.89
|
27.8 Maximum Percentage (%) Change
Standard Error 9.74
|
|
Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine
Fract. Excretion of Uric Acid % Change (48-72h)
|
14.2 Maximum Percentage (%) Change
Standard Error 9.43
|
4.18 Maximum Percentage (%) Change
Standard Error 10.7
|
1.67 Maximum Percentage (%) Change
Standard Error 4.01
|
2.27 Maximum Percentage (%) Change
Standard Error 8.29
|
Adverse Events
Cohort 1: Mild Renal Impairment + RDEA3170 15 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3: Severe Renal Impairment + RDEA3170 15 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4: Normal Renal Function + RDEA3170 15 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: Mild Renal Impairment + RDEA3170 15 mg
n=8 participants at risk
Mild Renal Impairment (eCrCl of 60 to \< 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
|
Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg
n=8 participants at risk
Moderate Renal Impairment (eCrCl of 30 to \< 60 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 3: Severe Renal Impairment + RDEA3170 15 mg
n=7 participants at risk
Severe Renal Impairment (eCrCl of 15 to \< 30 mL/min) + RDEA3170 15 mg qd fasted
|
Cohort 4: Normal Renal Function + RDEA3170 15 mg
n=8 participants at risk
Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
12.5%
1/8 • Number of events 1 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
14.3%
1/7 • Number of events 1 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/7 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • Number of events 1 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/7 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
12.5%
1/8 • Number of events 1 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/7 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/7 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
12.5%
1/8 • Number of events 1 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/7 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
12.5%
1/8 • Number of events 1 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
|
General disorders
Vessel puncture site haemorrhage
|
12.5%
1/8 • Number of events 1 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/7 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
14.3%
1/7 • Number of events 1 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/7 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
12.5%
1/8 • Number of events 1 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
|
Skin and subcutaneous tissue disorders
Pseudofolliculitis barbae
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/7 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
12.5%
1/8 • Number of events 1 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
|
Vascular disorders
Haematoma
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/8 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/7 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
12.5%
1/8 • Number of events 1 • 5 weeks
Overall number of baseline participants used to determine number of participants at risk.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI shall submit a copy of the Publication to Sponsor for review at least 45 days prior to its proposed submission. Sponsor reserves the right to delay any such publication for an additional period of 60 days. Upon Sponsor's request, PI agrees to delete from the proposed publication any Confidential Information. PI agrees not to release any publication without the prior written permission of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER