RDEA3170 Tablet and Capsule Bioavailability Study

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: RDEA3170,10 mg; Drug: RDEA3170, 5 mg; Drug: RDEA3170, 2.5 mg; Drug: RDEA3170, 10 mg

• Registration Number: NCT02448368
• Lead Sponsor: Ardea Biosciences, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-30
• Study Start: 2015-05-01
• Study First Submitted QC: 2015-05-15
• Study First Posted: 2015-05-19
• Primary Completion: 2015-06-26
• Study Completion: 2016-01-29
• Results First Submitted: 2017-06-12
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-17
• Last Update Submitted: 2017-11-17
• Results First Posted: 2018-08-20
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment D	RDEA3170,10 mg	RDEA3170, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal).
Treatment B	RDEA3170, 5 mg	RDEA3170, 5 mg (FN24), administered in the fed state (high-fat, high-calorie meal).
Treatment C	RDEA3170,10 mg	RDEA3170, 10 mg (FN25), administered in the fasted state.
Treatment E	RDEA3170, 2.5 mg	RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
Treatment J	RDEA3170, 10 mg	RDEA3170, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).
Treatment A	RDEA3170, 5 mg	RDEA3170, 5 mg (FN24), administered in the fasted state.
Treatment I	RDEA3170, 10 mg	RDEA3170, 10 mg (FN26), administered in the fasted state.
Treatment K	RDEA3170, 2.5 mg	RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics (PD) Profile of RDEA3170	Day -1, 1, 5, 9, 13, 17	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.
Incidence of Treatment-Emergent Adverse Events	8 weeks