The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules compared with RDEA3170 tablets.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
35
Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
Unnamed facility
Austin, Texas, United States
Maximum Observed Plasma Concentration (Cmax)
Cmax is the maximum observed concentration of a drug after administration
Time frame: Day 1, 5, 9, 13, 17
Time of Occurrence of Maximum Observed Concentration (Tmax)
Tmax is the time of occurrence of cmax
Time frame: Day 1, 5, 9, 13, 17
Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)
AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint
Time frame: Day 1, 5, 9, 13, 17
Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)
AUC 0-∞ is a meausre of total concentration from time zero to infinity
Time frame: Day 1, 5, 9, 13, 17
Apparent Terminal Half-life (t1/2)
t1/2 is a measure of apparent terminal half-life
Time frame: Day 1, 5, 9, 13, 17
Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules
Cmax is the maximum observed concentration of a drug after administration
Time frame: Day 1, 5, 9, 13, 17
AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules
AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint
Time frame: Day 1, 5, 9, 13, 17
AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules
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Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.
Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.
AUC 0-∞ is a meausre of total concentration from time zero to infinity
Time frame: Day 1, 5, 9, 13, 17
Pharmacodynamics (PD) Profile of RDEA3170
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.
Time frame: Day -1, 1, 5, 9, 13, 17
Incidence of Treatment-Emergent Adverse Events
Time frame: 8 weeks