This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD) study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
31
Unnamed facility
Lakewood, Colorado, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Minneapolis, Minnesota, United States
Unnamed facility
Knoxville, Tennessee, United States
Maximum Observed Plasma Concentration (Cmax)
Cmax following a single administration of RDEA3170 to subjects with various degrees of renal function
Time frame: 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
Time of Occurrence of Maximum Observed Concentration (Tmax)
Tmax following a single administration of RDEA3170 to subjects with various degrees of renal function
Time frame: 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
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
AUC last following a single administration of RDEA3170 to subjects with various degrees of renal function
Time frame: 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
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞)
AUC∞ following a single administration of RDEA3170 to subjects with various degrees of renal function
Time frame: 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
Apparent Terminal Half-life (t1/2)
t1/2 following a single administration of RDEA3170 to subjects with various degrees of renal function
Time frame: 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
Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72)
CLNR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function
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Time frame: 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
Total Body Clearance Corrected for Bioavailability (CL/F)
CL/F following a single administration of RDEA3170 to subjects with various degrees of renal function
Time frame: 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
Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72)
CLR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function
Time frame: 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
Incidence of Treatment-Emergent Adverse Events
Time frame: 5 weeks
Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine
Time frame: 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)