RDEA3170 Bioavailability Study

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02336594
• Other study ID #: RDEA3170-110
• Status: Completed
• Phase: Phase 1
• First received: November 6, 2014
• Last updated: October 9, 2017
• Start date: November 2014
• Est. completion date: March 2015

Study information

• Verified date: October 2017
• Source: Ardea Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• RDEA3170 10 mg

• RDEA3170 2.5 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ardea Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	Area Under the Concentration-time Curve From 0 to Infinity (AUC8)	AUC8 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.
Primary	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.
Primary	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.
Primary	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.
Primary	AUC8: Effect of High Fat Meal on the PK of RDEA3170 Tablets	AUC8 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.
Primary	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.
Primary	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.
Primary	AUC8: Effect of Low Fat Meal on the PK of RDEA3170 Tablets	AUC8 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	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.
Secondary	Incidence of Treatment-Emergent Adverse Events		7 weeks.