RDEA3170 Tablet and Capsule Bioavailability Study

A Phase 1, Randomized, Open-Label, Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability and Food Effect of Various Formulations of RDEA3170

The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules compared with RDEA3170 tablets.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: RDEA3170, 5 mg; Drug: RDEA3170,10 mg; Drug: RDEA3170, 2.5 mg; Drug: RDEA3170, 2.5 mg; Drug: RDEA3170, 10 mg

• Study Type: Interventional
• Enrollment (Actual): 35
• 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 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.

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

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A; RDEA3170, 5 mg (FN24), administered in the fasted state.	Drug: RDEA3170, 5 mg; Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.; Other Names: Cohort 1
Experimental: Treatment B; RDEA3170, 5 mg (FN24), administered in the fed state (high-fat, high-calorie meal).	Drug: RDEA3170, 5 mg; Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.; Other Names: Cohort 1
Experimental: Treatment C; RDEA3170, 10 mg (FN25), administered in the fasted state.	Drug: RDEA3170,10 mg; Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.; Other Names: Cohort 1
Experimental: Treatment D; RDEA3170, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal).	Drug: RDEA3170,10 mg; Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.; Other Names: Cohort 1
Experimental: Treatment E; RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.	Drug: RDEA3170, 2.5 mg; Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.; Other Names: Cohort 1; Drug: RDEA3170, 2.5 mg; Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.; Other Names: Cohort 3
Experimental: Treatment I; RDEA3170, 10 mg (FN26), administered in the fasted state.	Drug: RDEA3170, 10 mg; Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.; Other Names: Cohort 3
Experimental: Treatment J; RDEA3170, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).	Drug: RDEA3170, 10 mg; Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.; Other Names: Cohort 3
Experimental: Treatment K; RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.	Drug: RDEA3170, 2.5 mg; Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.; Other Names: Cohort 1; Drug: RDEA3170, 2.5 mg; Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.; Other Names: Cohort 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax)	Cmax is the maximum observed concentration of a drug after administration	Day 1, 5, 9, 13, 17
Time of Occurrence of Maximum Observed Concentration (Tmax)	Tmax is the time of occurrence of cmax	Day 1, 5, 9, 13, 17
Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)	AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint	Day 1, 5, 9, 13, 17
Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)	AUC 0-∞ is a meausre of total concentration from time zero to infinity	Day 1, 5, 9, 13, 17
Apparent Terminal Half-life (t1/2)	t1/2 is a measure of apparent terminal half-life	Day 1, 5, 9, 13, 17
Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules	Cmax is the maximum observed concentration of a drug after administration	Day 1, 5, 9, 13, 17
AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules	AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint	Day 1, 5, 9, 13, 17
AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules	AUC 0-∞ is a meausre of total concentration from time zero to infinity	Day 1, 5, 9, 13, 17

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamics (PD) Profile of RDEA3170	Serum samples were collected at the following timepoints in relation to RDEA3170 dosing: Day 1 (Cohort 1 and Cohort 3): -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours prior to dosing. Days 1, 5, and 9 (Cohort 1 and Cohort 3), and Days 13 and 17 (Cohort 1 only): predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose. Urine samples (total catch) were collected at the following timepoints in relation to RDEA3170 dosing: Day 1 (Cohort 1 and Cohort 3): -24 to -21, -21 to -18, -18 to -12, and -12 to 0 hours predose. Days 1, 5, and 9 (Cohort 1 and Cohort 3), and Days 13 and 17 (Cohort 1 only): 0 to 3, 3 to 6, 6 to 12, and 12 to 24 hours postdose.	Day -1, 1, 5, 9, 13, 17
Incidence of Treatment-Emergent Adverse Events		8 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 (Actual): May 1, 2015
• Primary Completion (Actual): June 26, 2015
• Study Completion (Actual): January 29, 2016

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: May 15, 2015
• First Posted (Estimate): May 19, 2015

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: November 17, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antirheumatic Agents; Gout Suppressants; Verinurad
• Other Study ID Numbers: RDEA3170-111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No