Trial Outcomes & Findings for RDEA3170 Tablet and Capsule Bioavailability Study (NCT NCT02448368)
NCT ID: NCT02448368
Last Updated: 2018-08-20
Results Overview
AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
Day 1, 5, 9, 13, 17
Results posted on
2018-08-20
Participant Flow
35 participants were randomized
Twenty subjects were randomized to 1 of 10 treatment sequences in Cohort 1 with single doses. Fifteen subjects were randomized to 1 of 3 treatment sequences (IJK, JKI, and KIJ) in optional Cohort 3, with single doses occurring on Days 1, 5, and 9. The optional Cohort 2 to evaluate RDEA3170 capsules, 5 mg FN23 was not conducted per Sponsor decision.
Participant milestones
| Measure |
Cohort 1: Sequence ABECD (Days 1, 5, 9, 13, and 17)
5 mg FN24 capsules, fasted; 5 mg FN24 capsules, fed; 10 mg FN17 tablets, fasted; 10 mg FN25 capsules, fasted; 10 mg FN25 capsules, fed
|
Cohort 1: Sequence AEBDC (Days 1, 5, 9, 13, and 17)
5 mg FN24 capsules, fasted; 10 mg FN17 tablets, fasted; 5 mg FN24 capsules, fed; 10 mg FN25 capsules, fed; 10 mg FN25 capsules, fasted
|
Cohort 1: Sequence EADBC (Days 1, 5, 9, 13, and 17)
10 mg FN17 tablets, fasted; 5 mg FN24 capsules, fasted; 10 mg FN25 capsules, fed; 5 mg FN24 capsules, fed; 10 mg FN25 capsules, fasted
|
Cohort 1: Sequence EDACB (Days 1, 5, 9, 13, and 17)
10 mg FN17 tablets, fasted; 10 mg FN25 capsules, fed; 5 mg FN24 capsules, fasted; 10 mg FN25 capsules, fasted; 5 mg FN24 capsules, fed
|
Cohort 1: Sequence DECAB (Days 1, 5, 9, 13, and 17)
10 mg FN25 capsules, fed; 10 mg FN17 tablets, fasted; 10 mg FN25 capsules, fasted; 5 mg FN24 capsules, fasted; 5 mg FN24 capsules, fed
|
Cohort 1: Sequence BACED (Days 1, 5, 9, 13, and 17)
5 mg FN24 capsules, fed; 5 mg FN24 capsules, fasted; 10 mg FN25 capsules, fasted; 10 mg FN17 tablets, fasted; 10 mg FN25 capsules, fed
|
Cohort 1: Sequence BCADE (Days 1, 5, 9, 13, and 17)
5 mg FN24 capsules, fed; 10 mg FN25 capsules, fasted; 5 mg FN24 capsules, fasted; 10 mg FN25 capsules, fed; 10 mg FN17 tablets, fasted
|
Cohort 1: Sequence CBDAE (Days 1, 5, 9, 13, and 17)
10 mg FN25 capsules, fasted; 5 mg FN24 capsules, fed; 10 mg FN25 capsules, fed; 5 mg FN24 capsules, fasted; 10 mg FN17 tablets, fasted
|
Cohort 1: Sequence CDBEA (Days 1, 5, 9, 13, and 17)
10 mg FN25 capsules, fasted; 10 mg FN25 capsules, fed; 5 mg FN24 capsules, fed; 10 mg FN17 tablets, fasted; 5 mg FN24 capsules, fasted
|
Cohort 1: Sequence DCEBA (Days 1, 5, 9, 13, and 17)
10 mg FN25 capsules, fed; 10 mg FN25 capsules, fasted; 10 mg FN17 tablets, fasted; 5 mg FN24 capsules, fed; 5 mg FN24 capsules, fasted
|
Cohort 3: Sequence IJK (Days 1, 5, and 9)
10 mg FN26 capsules, fasted; 10 mg FN26 capsules, fed; 10 mg FN17 tablets, fasted
|
Cohort 3: Sequence JKI (Days 1, 5, and 9)
10 mg FN26 capsules, fed; 10 mg FN17 tablets, fasted; 10 mg FN26 capsules, fasted
|
Cohort 3: Sequence KIJ (Days 1, 5, and 9)
10 mg FN17 tablets, fasted; 10 mg FN26 capsules, fasted; 10 mg FN26 capsules, fed
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RDEA3170 Tablet and Capsule Bioavailability Study
Baseline characteristics by cohort
| Measure |
Cohort 1
n=20 Participants
Treatment A: RDEA3170 capsules, 5 mg (FN24), administered in the fasted state. Treatment B: RDEA3170 capsules, 5 mg FN24, administered in the fed state (high-fat, high-calorie meal). Treatment C: RDEA3170 capsules, 10 mg (FN25), administered in the fasted state. Treatment D: RDEA3170 capsules, 10 mg FN25, administered in the fed state (high-fat, high-calorie meal). Treatment E: RDEA3170 tablets, 2.5 mg FN17, administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
Cohort 3 (Optional)
n=15 Participants
Treatment I: RDEA3170 capsules, 10 mg (FN26), administered in the fasted state. Treatment J: RDEA3170 capsules, 10 mg FN26, administered in the fed state (high-fat, high-calorie meal).
Treatment K: RDEA3170 tablets, 2.5 mg FN17, administered as 10 mg (4 × 2.5 mg), in the fasted state
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
41 Years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
38 Years
STANDARD_DEVIATION 10.45 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1, 5, 9, 13, 17Population: A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.
Cmax is the maximum observed concentration of a drug after administration
Outcome measures
| Measure |
Treatment A
n=19 Participants
Verinurad capsules, 5 mg (FN24), administered in the fasted state.
|
Treatment C
n=20 Participants
Verinurad capsules, 10 mg (FN25), administered in the fasted state.
|
Treatment E
n=20 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
Treatment I
n=15 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment K
n=15 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state
|
Treatment I
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment J
RDEA3170 capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).
|
Treatment K
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
14.9 ng/mL
Interval 12.5 to 17.8
|
23.4 ng/mL
Interval 19.3 to 28.2
|
12.9 ng/mL
Interval 11.2 to 14.9
|
14.0 ng/mL
Interval 12.1 to 16.3
|
13.2 ng/mL
Interval 11.2 to 15.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1, 5, 9, 13, 17Population: A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.
Tmax is the time of occurrence of cmax
Outcome measures
| Measure |
Treatment A
n=19 Participants
Verinurad capsules, 5 mg (FN24), administered in the fasted state.
|
Treatment C
n=20 Participants
Verinurad capsules, 10 mg (FN25), administered in the fasted state.
|
Treatment E
n=20 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
Treatment I
n=20 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment K
n=20 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state
|
Treatment I
n=15 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment J
n=15 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).
|
Treatment K
n=15 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
|---|---|---|---|---|---|---|---|---|
|
Time of Occurrence of Maximum Observed Concentration (Tmax)
|
3.00 hr
Full Range 2.05 • Interval 1.0 to 4.0
|
4.00 hr
Full Range 1.69 • Interval 3.0 to 10.0
|
3.50 hr
Full Range 1.74 • Interval 1.0 to 6.0
|
4.00 hr
Full Range 1.05 • Interval 3.0 to 8.0
|
2.00 hr
Full Range 1.54 • Interval 1.0 to 4.0
|
2.00 hr
Full Range 2.71 • Interval 1.0 to 6.0
|
6.00 hr
Full Range 2.45 • Interval 3.0 to 12.0
|
3.00 hr
Full Range 2.66 • Interval 1.0 to 6.0
|
PRIMARY outcome
Timeframe: Day 1, 5, 9, 13, 17Population: A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.
AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint
Outcome measures
| Measure |
Treatment A
n=19 Participants
Verinurad capsules, 5 mg (FN24), administered in the fasted state.
|
Treatment C
n=20 Participants
Verinurad capsules, 10 mg (FN25), administered in the fasted state.
|
Treatment E
n=20 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
Treatment I
n=15 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment K
n=15 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state
|
Treatment I
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment J
RDEA3170 capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).
|
Treatment K
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)
|
91.2 ng·hr/mL
Interval 80.6 to 103.0
|
185 ng·hr/mL
Interval 163.0 to 211.0
|
109 ng·hr/mL
Interval 89.9 to 132.0
|
149 ng·hr/mL
Interval 130.0 to 171.0
|
115 ng·hr/mL
Interval 96.9 to 137.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1, 5, 9, 13, 17Population: A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.
AUC 0-∞ is a meausre of total concentration from time zero to infinity
Outcome measures
| Measure |
Treatment A
n=19 Participants
Verinurad capsules, 5 mg (FN24), administered in the fasted state.
|
Treatment C
n=20 Participants
Verinurad capsules, 10 mg (FN25), administered in the fasted state.
|
Treatment E
n=20 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
Treatment I
n=20 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment K
n=20 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state
|
Treatment I
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment J
RDEA3170 capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).
|
Treatment K
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)
|
95.7 ng·hr/mL
Interval 84.5 to 108.0
|
192 ng·hr/mL
Interval 169.0 to 219.0
|
121 ng·hr/mL
Interval 97.0 to 150.0
|
161 ng·hr/mL
Interval 140.0 to 184.0
|
123 ng·hr/mL
Interval 103.0 to 146.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1, 5, 9, 13, 17Population: A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.
t1/2 is a measure of apparent terminal half-life
Outcome measures
| Measure |
Treatment A
n=19 Participants
Verinurad capsules, 5 mg (FN24), administered in the fasted state.
|
Treatment C
n=20 Participants
Verinurad capsules, 10 mg (FN25), administered in the fasted state.
|
Treatment E
n=20 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
Treatment I
n=20 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment K
n=20 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state
|
Treatment I
n=15 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment J
n=15 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).
|
Treatment K
n=15 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2)
|
13.6 hr
95% Confidence Interval 2.05 • Interval 11.2 to 16.5
|
14.9 hr
95% Confidence Interval 1.69 • Interval 12.6 to 17.6
|
14.0 hr
95% Confidence Interval 1.74 • Interval 11.5 to 17.0
|
12.9 hr
95% Confidence Interval 1.05 • Interval 10.6 to 15.6
|
17.3 hr
95% Confidence Interval 1.54 • Interval 13.4 to 22.3
|
14.4 hr
95% Confidence Interval 2.71 • Interval 9.7 to 21.5
|
15.8 hr
95% Confidence Interval 2.45 • Interval 11.6 to 21.5
|
13.2 hr
95% Confidence Interval 2.66 • Interval 9.44 to 18.6
|
PRIMARY outcome
Timeframe: Day 1, 5, 9, 13, 17Population: A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.
Cmax is the maximum observed concentration of a drug after administration
Outcome measures
| Measure |
Treatment A
n=19 Participants
Verinurad capsules, 5 mg (FN24), administered in the fasted state.
|
Treatment C
n=20 Participants
Verinurad capsules, 10 mg (FN25), administered in the fasted state.
|
Treatment E
n=20 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
Treatment I
n=20 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment K
n=15 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state
|
Treatment I
n=15 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment J
RDEA3170 capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).
|
Treatment K
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules
|
14.9 ng/mL
Interval 12.5 to 17.8
|
15.0 ng/mL
Interval 12.6 to 18.0
|
23.4 ng/mL
Interval 19.3 to 28.2
|
23.3 ng/mL
Interval 19.2 to 28.3
|
14.0 ng/mL
Interval 12.1 to 16.3
|
16.3 ng/mL
Interval 12.9 to 20.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1, 5, 9, 13, 17Population: A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.
AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint
Outcome measures
| Measure |
Treatment A
n=19 Participants
Verinurad capsules, 5 mg (FN24), administered in the fasted state.
|
Treatment C
n=20 Participants
Verinurad capsules, 10 mg (FN25), administered in the fasted state.
|
Treatment E
n=20 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
Treatment I
n=20 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment K
n=15 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state
|
Treatment I
n=15 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment J
RDEA3170 capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).
|
Treatment K
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
|---|---|---|---|---|---|---|---|---|
|
AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules
|
91.2 ng·hr/mL
Interval 80.6 to 103.0
|
99.2 ng·hr/mL
Interval 86.4 to 114.0
|
185 ng·hr/mL
Interval 163.0 to 211.0
|
192 ng·hr/mL
Interval 171.0 to 216.0
|
149 ng·hr/mL
Interval 130.0 to 171.0
|
172 ng·hr/mL
Interval 136.0 to 218.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1, 5, 9, 13, 17Population: A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.
AUC 0-∞ is a meausre of total concentration from time zero to infinity
Outcome measures
| Measure |
Treatment A
n=19 Participants
Verinurad capsules, 5 mg (FN24), administered in the fasted state.
|
Treatment C
n=20 Participants
Verinurad capsules, 10 mg (FN25), administered in the fasted state.
|
Treatment E
n=20 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
Treatment I
n=20 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment K
n=15 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state
|
Treatment I
n=15 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment J
RDEA3170 capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).
|
Treatment K
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
|---|---|---|---|---|---|---|---|---|
|
AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules
|
95.7 ng·hr/mL
Interval 84.5 to 108.0
|
104 ng·hr/mL
Interval 90.5 to 119.0
|
192 ng·hr/mL
Interval 169.0 to 219.0
|
199 ng·hr/mL
Interval 177.0 to 224.0
|
161 ng·hr/mL
Interval 140.0 to 184.0
|
182 ng·hr/mL
Interval 142.0 to 233.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -1, 1, 5, 9, 13, 17Population: A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 (but not from pharmacodynamics analysis) following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.
Serum samples were collected at the following timepoints in relation to RDEA3170 dosing: Day 1 (Cohort 1 and Cohort 3): -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours prior to dosing. Days 1, 5, and 9 (Cohort 1 and Cohort 3), and Days 13 and 17 (Cohort 1 only): predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose. Urine samples (total catch) were collected at the following timepoints in relation to RDEA3170 dosing: Day 1 (Cohort 1 and Cohort 3): -24 to -21, -21 to -18, -18 to -12, and -12 to 0 hours predose. Days 1, 5, and 9 (Cohort 1 and Cohort 3), and Days 13 and 17 (Cohort 1 only): 0 to 3, 3 to 6, 6 to 12, and 12 to 24 hours postdose.
Outcome measures
| Measure |
Treatment A
n=20 Participants
Verinurad capsules, 5 mg (FN24), administered in the fasted state.
|
Treatment C
n=20 Participants
Verinurad capsules, 10 mg (FN25), administered in the fasted state.
|
Treatment E
n=20 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
Treatment I
n=20 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment K
n=20 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state
|
Treatment I
n=15 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment J
n=15 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).
|
Treatment K
n=15 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD) Profile of RDEA3170
Serum Urate Maximum % Change
|
-29.1 Percent (%) Change
Standard Error 2.05
|
-40.6 Percent (%) Change
Standard Error 1.69
|
-42.5 Percent (%) Change
Standard Error 1.74
|
-52.3 Percent (%) Change
Standard Error 1.05
|
-30.3 Percent (%) Change
Standard Error 1.54
|
-35.2 Percent (%) Change
Standard Error 2.71
|
-46.2 Percent (%) Change
Standard Error 2.45
|
-29.3 Percent (%) Change
Standard Error 2.66
|
|
Pharmacodynamics (PD) Profile of RDEA3170
Urine Uric Acid % Change (0-24h)
|
79.2 Percent (%) Change
Standard Error 21.6 • Interval 33.9 to 124.0
|
92.3 Percent (%) Change
Standard Error 19.0 • Interval 52.5 to 132.0
|
109 Percent (%) Change
Standard Error 27.8 • Interval 51.2 to 168.0
|
88.8 Percent (%) Change
Standard Error 13.6 • Interval 60.3 to 117.0
|
76.8 Percent (%) Change
Standard Error 14.4 • Interval 46.6 to 107.0
|
49.5 Percent (%) Change
Standard Error 8.22 • Interval 31.9 to 67.1
|
53.7 Percent (%) Change
Standard Error 8.56 • Interval 35.4 to 72.1
|
53.9 Percent (%) Change
Standard Error 10.0 • Interval 32.4 to 75.3
|
|
Pharmacodynamics (PD) Profile of RDEA3170
Renal Clearance of Uric Acid % Change (0-24h)
|
137 Percent (%) Change
Standard Error 33.1 • Interval 10.9 to 14.6
|
175 Percent (%) Change
Standard Error 27.2 • Interval 13.9 to 17.2
|
226 Percent (%) Change
Standard Error 48.4 • Interval 15.3 to 20.1
|
216 Percent (%) Change
Standard Error 23.7 • Interval 15.1 to 20.9
|
142 Percent (%) Change
Standard Error 27.1 • Interval 11.7 to 15.3
|
117 Percent (%) Change
Standard Error 17.4 • Interval 12.0 to 16.5
|
153 Percent (%) Change
Standard Error 17.2 • Interval 14.4 to 19.8
|
107 Percent (%) Change
Standard Error 17.7 • Interval 11.6 to 15.4
|
|
Pharmacodynamics (PD) Profile of RDEA3170
Fractional Excretion of uric acid % Change (0-24h)
|
119 Percent (%) Change
Standard Error 13.1 • Interval 9.82 to 13.3
|
157 Percent (%) Change
Standard Error 12.9 • Interval 12.0 to 15.5
|
214 Percent (%) Change
Standard Error 14.5 • Interval 15.0 to 18.8
|
214 Percent (%) Change
Standard Error 14.3 • Interval 15.0 to 18.6
|
145 Percent (%) Change
Standard Error 15.1 • Interval 11.1 to 14.7
|
137 Percent (%) Change
Standard Error 18.4 • Interval 11.2 to 15.3
|
168 Percent (%) Change
Standard Error 15.5 • Interval 13.5 to 17.6
|
120 Percent (%) Change
Standard Error 14.2 • Interval 10.5 to 14.3
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The safety population included all participants who received any dose of investigational product.
Outcome measures
| Measure |
Treatment A
n=20 Participants
Verinurad capsules, 5 mg (FN24), administered in the fasted state.
|
Treatment C
n=20 Participants
Verinurad capsules, 10 mg (FN25), administered in the fasted state.
|
Treatment E
n=20 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
Treatment I
n=20 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment K
n=20 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state
|
Treatment I
n=15 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment J
n=15 Participants
RDEA3170 capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).
|
Treatment K
n=15 Participants
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
|---|---|---|---|---|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events
|
1 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
2 Number of participants
|
2 Number of participants
|
0 Number of participants
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment E
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment I
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment J
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment K
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A
n=20 participants at risk
Verinurad capsules, 5 mg (FN24), administered in the fasted state.
|
Treatment B
n=20 participants at risk
Verinurad capsules, 5 mg (FN24), administered in the fed state (highfat, high-calorie meal).
|
Treatment C
n=20 participants at risk
Verinurad capsules, 10 mg (FN25), administered in the fasted state.
|
Treatment D
n=20 participants at risk
RDEA3170 capsules, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal)
|
Treatment E
n=20 participants at risk
RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
Treatment I
n=15 participants at risk
Verinurad capsules, 10 mg (FN26), administered in the fasted state.
|
Treatment J
n=15 participants at risk
Verinurad capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).
|
Treatment K
n=15 participants at risk
Verinurad tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Viral Infection
|
5.0%
1/20 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/20
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/20
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/20
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/20
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/15
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/15
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/15
Overall number of baseline participants used to determine number of participants at risk.
|
|
Nervous system disorders
Headache
|
0.00%
0/20
Overall number of baseline participants used to determine number of participants at risk.
|
5.0%
1/20 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/20
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/20
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/20
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/15
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/15
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/15
Overall number of baseline participants used to determine number of participants at risk.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/20
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/20
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/20
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/20
Overall number of baseline participants used to determine number of participants at risk.
|
13.3%
2/15 • Number of events 2
Overall number of baseline participants used to determine number of participants at risk.
|
6.7%
1/15 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/15
Overall number of baseline participants used to determine number of participants at risk.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/20
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/20
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/20
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/20
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/20
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/15
Overall number of baseline participants used to determine number of participants at risk.
|
6.7%
1/15 • Number of events 1
Overall number of baseline participants used to determine number of participants at risk.
|
0.00%
0/15
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