Phase 1
Completed N=35
RDEA3170 Tablet and Capsule Bioavailability Study
Healthy
Source: ClinicalTrials.gov NCT02448368 ↗
Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) — 14.9; 23.4; 12.9; 14.0 ng/mL
Summary
The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules compared with RDEA3170 tablets.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
14.9; 23.4; 12.9; 14.0; 13.2 | — |
| PRIMARY Time of Occurrence of Maximum Observed Concentration (Tmax) |
3.00; 4.00; 3.50; 4.00; 2.00; 2.00 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last) |
91.2; 185; 109; 149; 115 | — |
| PRIMARY Area Under the Concentration-time Curve From 0 to Infinity (AUC∞) |
95.7; 192; 121; 161; 123 | — |
| PRIMARY Apparent Terminal Half-life (t1/2) |
13.6; 14.9; 14.0; 12.9; 17.3; 14.4 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules |
14.9; 15.0; 23.4; 23.3; 14.0; 16.3 | — |
| PRIMARY AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules |
91.2; 99.2; 185; 192; 149; 172 | — |
| PRIMARY AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules |
95.7; 104; 192; 199; 161; 182 | — |
| SECONDARY Pharmacodynamics (PD) Profile of RDEA3170 |
-29.1; -40.6; -42.5; -52.3; -30.3; -35.2 | — |
| SECONDARY Incidence of Treatment-Emergent Adverse Events |
1; 1; 0; 0; 0; 2 | — |
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 of 4 to 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 within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1.
- Subject has clinically unacceptable physical examination, per the Investigator's judgment.
- Subject has clinically relevant abnormalities in blood pressure, heart rate, or body temperature, per the Investigator's judgment.
- Subject has Screening clinical safety laboratory parameters (serum chemistry [other than serum creatinine and serum urate], hematology, coagulation or urinalysis) that are outside the normal limits and are considered clinically significant by the Investigator.
- Subject has a serum creatinine value above the upper limit of normal at the Screening visit.
- Subject has clinically relevant abnormalities in 12-lead electrocardiogram, per the Investigator's judgment.
- Subject has a history of cardiac abnormalities
- Subject cannot swallow multiple tablets or capsules.
- Subject has received any strong or moderate enzyme-inducing drug or product within 2 months prior to Day 1.
Data sourced from ClinicalTrials.gov (NCT02448368). 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.