A Phase 1, Randomized, Open-Label, Crossover Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability of Two RDEA3170 Tablets
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Ardea Biosciences, Inc.
- Enrollment
- 15
- Primary Endpoint
- Maximum Observed Plasma Concentration (Cmax)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Sequence ABCD
2.5 mg x 4 tablets qd (once daily) fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat.
Intervention: RDEA3170 2.5 mg (Drug)
Sequence ABCD
2.5 mg x 4 tablets qd (once daily) fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat.
Intervention: RDEA3170 10 mg (Drug)
Sequence BACD
10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat
Intervention: RDEA3170 10 mg (Drug)
Sequence BACD
10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat
Intervention: RDEA3170 2.5 mg (Drug)
Sequence ABDC
2.5 x 4 mg tablets qd fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat
Intervention: RDEA3170 10 mg (Drug)
Sequence ABDC
2.5 x 4 mg tablets qd fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat
Intervention: RDEA3170 2.5 mg (Drug)
Sequence BADC
10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat
Intervention: RDEA3170 10 mg (Drug)
Sequence BADC
10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat
Intervention: RDEA3170 2.5 mg (Drug)
Outcomes
Primary Outcomes
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
Cmax of RDEA3170 in fasted condition.
Time of Occurrence of Maximum Observed Concentration (Tmax)
Time Frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
Tmax of RDEA3170 following various treatments.
Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)
Time Frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
AUC last of RDEA3170 in fasted condition.
Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)
Time Frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
AUC∞ of RDEA3170 the fasted condition.
Apparent Terminal Half-life (t1/2)
Time Frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
t1/2 of RDEA3170 following various treatments.
Cmax: Effect of High Fat Meal on the PK of RDEA3170 Tablets
Time Frame: Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
Cmax of RDEA3170 in high-fat fed state.
AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Tablets
Time Frame: Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
AUC last of RDEA3170 in high-fat fed state.
AUC Last: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
Time Frame: Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
AUC last of RDEA3170 in low-fat fed state.
AUC∞: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
Time Frame: Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
AUC∞ of RDEA3170 in low-fat fed state.
AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Tablets
Time Frame: Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
AUC∞ of RDEA3170 in high-fat fed state.
Cmax: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
Time Frame: Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
Cmax of RDEA3170 in low-fat fed state.
Secondary Outcomes
- Incidence of Treatment-Emergent Adverse Events(7 weeks.)
- Single Dose Pharmacodynamics (PD) Profile of RDEA3170 From Serum and Urine(Day -1: -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours predose. Days 1, 5, 9, and 13: predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose.)