RDEA3170 Bioavailability Study

A Phase 1, Randomized, Open-Label, Crossover Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability of Two RDEA3170 Tablets

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 Overview

• Status: Completed
• Conditions: Gout
• Intervention / Treatment: Drug: RDEA3170 10 mg; Drug: RDEA3170 2.5 mg

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: RDEA3170 10 mg; Drug: RDEA3170 2.5 mg
Experimental: 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	Drug: RDEA3170 10 mg; Drug: RDEA3170 2.5 mg
Experimental: 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	Drug: RDEA3170 10 mg; Drug: RDEA3170 2.5 mg
Experimental: 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	Drug: RDEA3170 10 mg; Drug: RDEA3170 2.5 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax)	Cmax of RDEA3170 in fasted condition.	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.
Time of Occurrence of Maximum Observed Concentration (Tmax)	Tmax of RDEA3170 following various treatments.	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.
Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)	AUC last of RDEA3170 in fasted condition.	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.
Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)	AUC∞ of RDEA3170 the fasted condition.	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.
Apparent Terminal Half-life (t1/2)	t1/2 of RDEA3170 following various treatments.	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: Effect of High Fat Meal on the PK of RDEA3170 Tablets	Cmax of RDEA3170 in high-fat fed state.	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: Effect of High Fat Meal on the PK of RDEA3170 Tablets	AUC last of RDEA3170 in high-fat fed state.	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∞: Effect of High Fat Meal on the PK of RDEA3170 Tablets	AUC∞ of RDEA3170 in high-fat fed state.	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: Effect of Low Fat Meal on the PK of RDEA3170 Tablets	Cmax of RDEA3170 in low-fat fed state.	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: Effect of Low Fat Meal on the PK of RDEA3170 Tablets	AUC last of RDEA3170 in low-fat fed state.	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∞: Effect of Low Fat Meal on the PK of RDEA3170 Tablets	AUC∞ of RDEA3170 in low-fat fed state.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single Dose Pharmacodynamics (PD) Profile of RDEA3170 From Serum and Urine	PD profiles of uric acid from serum and urine. PD parameters were evaluated to assess whether any potential differences in PK for the 2 different tablets resulted in differences in uric acid excretion.	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.
Incidence of Treatment-Emergent Adverse Events		7 weeks.

Collaborators and Investigators

• Sponsor: Ardea Biosciences, Inc.
• Investigators: Study Director: J. Hall, MD, Ardea Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: November 6, 2014
• First Submitted That Met QC Criteria: January 9, 2015
• First Posted (Estimate): January 13, 2015

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 9, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antirheumatic Agents; Gout Suppressants; Verinurad
• Other Study ID Numbers: RDEA3170-110