Clinical trial NCT02336594: RDEA3170 Bioavailability Study
Official title: A Phase 1, Randomized, Open-Label, Crossover Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability of Two RDEA3170 Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-13
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 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.
measure: Time of Occurrence of Maximum Observed Concentration (Tmax)
timeFrame: 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.
measure: Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)
timeFrame: 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.
measure: Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)
timeFrame: 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.
measure: Apparent Terminal Half-life (t1/2)
timeFrame: 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.
measure: Cmax: Effect of High Fat Meal on the PK of RDEA3170 Tablets
timeFrame: 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.
measure: AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Tablets
timeFrame: 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.
measure: AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Tablets
timeFrame: 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.
measure: Cmax: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
timeFrame: 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.
measure: AUC Last: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
timeFrame: 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.
measure: AUC∞: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
timeFrame: 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.
Secondary outcomes:
measure: Single Dose Pharmacodynamics (PD) Profile of RDEA3170 From Serum and Urine
timeFrame: 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.
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 7 weeks.
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
affiliation: Ardea Biosciences, Inc.
name: J. Hall, MD
role: STUDY_DIRECTOR
References: