Mild, Moderate and Severe Renal Impairment Study

Gout Clinical Trial

Official title:

A Phase 1, Single-Dose, Open Label, Pharmacokinetic and Pharmacodynamic Study of RDEA3170 in Adult Male Subjects With Mild, Moderate, and Severe Renal Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219516
• Other study ID #: RDEA3170-108
• Status: Completed
• Phase: Phase 1
• First received: August 15, 2014
• Last updated: August 30, 2016
• Start date: August 2014
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Ardea Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD) study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Subject has a body weight = 50 kg (110 lbs.) and a body mass index = 18 and = 40 kg/m2.

• Subject with renal impairment, as determined at Screening, with creatinine clearance as calculated by the Cockcroft-Gault formula of 60 to < 90 mL/min (mild impairment), 30 to < 60 mL/min (moderate impairment), or 15 to < 30 mL/min (severe impairment), or a matched control subject (by age and body mass index) with a creatinine clearance of = 90 mL/min.

• Subject has a Screening serum urate level = 4.5 mg/dL and = 10 mg/dL

Exclusion Criteria:

• Subject has a history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.

• Subject has a history or suspicion of kidney stones.

• Subject has a history of asthma.

• Subject has undergone major surgery within 3 months prior to Day 1.

• Subject has donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Gout
• Renal Insufficiency

Intervention

Drug:
• RDEA3170

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	PK profile of RDEA3170 from plasma and urine	PK endpoints in terms of maximum observed concentration (Cmax); time of occurrence of maximum observed concentration (Tmax); area under the plasma concentration time curve (AUC); apparent terminal half-life (t1/2); Non-renal clearance (CLNR); renal clearance (CLR); and total body clearance corrected for bioavailability (CL/F)	Plasma measured Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose	No
Secondary	PD profile of RDEA3170 from serum and urine PD profile of RDEA3170 from serum and urine	PD endpoints in terms of serum urate concentration, urine uric acid excretion amount, renal clearance of uric acid, and fractional excretion of uric acid.	Screening, Day -1 ( -24, -21, -18, -and -12 hours predose), and Day 1 (within 30 minutes prior to dosing and at 3, 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours postdose)	No
Secondary	Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters		5 weeks	Yes