Phase 1
N=31
Mild, Moderate and Severe Renal Impairment Study
Gout
Bottom Line
View on ClinicalTrials.gov: NCT02219516 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Maximum Observed Plasma Concentration (Cmax) — 25.6; 29.0; 38.2; 16.7 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- RDEA3170 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Ardea Biosciences, Inc.
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
25.6; 29.0; 38.2; 16.7 | — |
| PRIMARY Time of Occurrence of Maximum Observed Concentration (Tmax) |
2.50; 3.00; 2.00; 2.50 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last) |
197; 333; 316; 150 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) |
201; 402; 372; 162 | — |
| PRIMARY Apparent Terminal Half-life (t1/2) |
9.53; 20.6; 22.0; 13.0 | — |
| PRIMARY Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72) |
74.9; 44.5; 47.2; 98.6 | — |
| PRIMARY Total Body Clearance Corrected for Bioavailability (CL/F) |
74.8; 37.3; 40.3; 92.6 | — |
| PRIMARY Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72) |
12.9; 7.87; 2.86; 13.5 | — |
| SECONDARY Incidence of Treatment-Emergent Adverse Events |
3; 1; 2; 1 | — |
| SECONDARY Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine |
-36.9; -20.5; -12.6; -38.3; 118; 69.3 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
- Subject with renal impairment, as determined at Screening, with creatinine clearance as calculated by the Cockcroft-Gault formula of 60 to 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation
Data sourced from ClinicalTrials.gov (NCT02219516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.