Phase 1
Completed N=15
RDEA3170 Bioavailability Study
Source: ClinicalTrials.gov NCT02336594 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) — 14.1; 14.9 ng/mL
Summary
This is a Phase 1, randomized, open-label, 4-way crossover pharmacokinetic (PK) and pharmacodynamic (PD) study in healthy adult male subjects designed to assess the relative bioavailability of RDEA3170 2.5 mg tablets administered as a 10 mg dose (2.5 mg × 4 tablets) and of a single RDEA3170 10 mg tablet. This study will also assess the effect of a low-fat and high-fat meal on the PK and PD of RDEA3170 10 mg tablets.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
14.1; 14.9 | — |
| PRIMARY Time of Occurrence of Maximum Observed Concentration (Tmax) |
2.00; 2.00; 2.00; 4.00 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last) |
119; 114 | — |
| PRIMARY Area Under the Concentration-time Curve From 0 to Infinity (AUC∞) |
131; 130 | — |
| PRIMARY Apparent Terminal Half-life (t1/2) |
16.5; 15.5; 15.4; 16.6 | — |
| PRIMARY Cmax: Effect of High Fat Meal on the PK of RDEA3170 Tablets |
14.9; 27.2 | — |
| PRIMARY AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Tablets |
114; 160 | — |
| PRIMARY AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Tablets |
130; 173 | — |
| PRIMARY Cmax: Effect of Low Fat Meal on the PK of RDEA3170 Tablets |
14.9; 11.8 | — |
| PRIMARY AUC Last: Effect of Low Fat Meal on the PK of RDEA3170 Tablets |
114; 97.8 | — |
| PRIMARY AUC∞: Effect of Low Fat Meal on the PK of RDEA3170 Tablets |
130; 108 | — |
| SECONDARY Single Dose Pharmacodynamics (PD) Profile of RDEA3170 From Serum and Urine |
-34.4; -34.4; -37.3; -49.0; 96.6; 78.5 | — |
| SECONDARY Incidence of Treatment-Emergent Adverse Events |
0; 1; 1; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity
- Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2
- Subject has a Screening serum urate level ≤ 7 mg/dL
- Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment
Exclusion Criteria
- Subject has a history or suspicion of kidney stones
- Subject has undergone major surgery within 3 months prior to Screening
- Subject donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1
- Subject has inadequate venous access or unsuitable veins for repeated venipuncture
- Subject has a Screening serum creatinine value above the upper limit of normal during Screening or at Day -2 (Admission)
- Subject cannot swallow multiple tablets
- Subject is a heavy caffeine drinker
- Subject is unwilling to comply with the dietary restrictions of the study
- Subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study
Data sourced from ClinicalTrials.gov (NCT02336594). 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. Informational only — not medical advice.