RDEA3170 PK/PD Study

Gout Clinical Trial

Official title:

A Phase 1, Randomized, Open-Label Study in Healthy Adult Male Subjects to Assess the Pharmacokinetics and Pharmacodynamics of RDEA3170

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608710
• Other study ID #: RDEA3170-112
• Status: Completed
• Phase: Phase 1
• First received: November 15, 2015
• Last updated: August 31, 2016
• Start date: November 2015
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: Ardea Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of RDEA3170 when given as single or multiple doses

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 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 has received any strong or moderate enzyme-inducing drug or product within 2 months prior to Day 1.

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• RDEA3170 4.5 mg

• RDEA3170 6 mg

• RDEA3170 12 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 concentration (Cmax)	Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg	Days -1, 1, 5 and 9
Primary	Cmax	Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg	Days -1, 1 and 7
Primary	Cmax	Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions	Days -1, 1, 7 and 8
Primary	Time of Occurrence of maximum observed concentration (Tmax)	Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg	Days -1, 1, 5 and 9
Primary	Area under the plasma concentration time curve (AUC)	Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg	Days -1, 1, 5 and 9
Primary	Tmax	Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg	Days -1, 1 and 7
Primary	AUC	Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg	Days -1, 1 and 7
Primary	Tmax	Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions	Days -1, 1, 7 and 8
Primary	AUC	Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions	Days -1, 1, 7 and 8
Primary	Serum urate concentration	Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg	Days -1, 1, 5 and 9
Primary	Urine uric acid excretion amount	Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg	Days -1, 1, 5 and 9
Primary	Renal clearance of uric acid	Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg	Days -1, 1, 5 and 9
Primary	Fractional excretion of uric acid	Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg	Days -1, 1, 5 and 9
Primary	Serum urate concentration	Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg	Days -1, 1 and 7
Primary	Urine uric acid excretion amount	Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg	Days -1, 1 and 7
Primary	Renal clearance of uric acid	Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg	Days -1, 1 and 7
Primary	Fractional excretion of uric acid	Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg	Days -1, 1 and 7
Primary	Serum urate concentration	Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions	Days -1, 1, 7 and 8
Primary	Urine uric acid excretion amount	Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions	Days -1, 1, 7 and 8
Primary	Renal Clearance of Uric Acid	Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions	Days -1, 1, 7 and 8
Primary	Fractional excretion of uric acid	Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions	Days -1, 1, 7 and 8
Secondary	Incidence of Adverse Events in terms of changes in laboratory parameters		6 weeks
Secondary	Incidence of Adverse Events in terms of electrocardiogram parameters		6 weeks
Secondary	Incidence of Adverse Events in terms of vital signs		6 weeks
Secondary	Incidence of Adverse Events in terms of physical examination findings		6 weeks
Secondary	Apparent terminal half-life (t1/2)	Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg from plasma and urine	Days -1, 1, 5 and 9
Secondary	t1/2	Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions	Days -1, 1, 7 and 8
Secondary	t1/2	Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg from plasma and urine	Days -1, 1 and 7