Austin, Texas, 78744, United States
NCT Number: NCT02608710
RDEA3170 PK/PD Study
The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of RDEA3170 when given as single or multiple doses
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
RDEA3170 4.5 mg
DrugRDEA3170 6 mg
DrugRDEA3170 12 mg
DrugPrimary outcomes
-
Maximum observed concentration (Cmax)
Time frame: Days -1, 1, 5 and 9
Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
-
Cmax
Time frame: Days -1, 1 and 7
Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg
-
Cmax
Time frame: Days -1, 1, 7 and 8
Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
-
Time of Occurrence of maximum observed concentration (Tmax)
Time frame: Days -1, 1, 5 and 9
Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
-
Area under the plasma concentration time curve (AUC)
Time frame: Days -1, 1, 5 and 9
Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
-
Tmax
Time frame: Days -1, 1 and 7
Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg
-
AUC
Time frame: Days -1, 1 and 7
Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg
-
Tmax
Time frame: Days -1, 1, 7 and 8
Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
-
AUC
Time frame: Days -1, 1, 7 and 8
Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
-
Serum urate concentration
Time frame: Days -1, 1, 5 and 9
Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
-
Urine uric acid excretion amount
Time frame: Days -1, 1, 5 and 9
Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
-
Renal clearance of uric acid
Time frame: Days -1, 1, 5 and 9
Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
-
Fractional excretion of uric acid
Time frame: Days -1, 1, 5 and 9
Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
-
Serum urate concentration
Time frame: Days -1, 1 and 7
Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
-
Urine uric acid excretion amount
Time frame: Days -1, 1 and 7
Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
-
Renal clearance of uric acid
Time frame: Days -1, 1 and 7
Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
-
Fractional excretion of uric acid
Time frame: Days -1, 1 and 7
Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
-
Serum urate concentration
Time frame: Days -1, 1, 7 and 8
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
-
Urine uric acid excretion amount
Time frame: Days -1, 1, 7 and 8
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
-
Renal Clearance of Uric Acid
Time frame: Days -1, 1, 7 and 8
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
-
Fractional excretion of uric acid
Time frame: Days -1, 1, 7 and 8
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
Secondary outcomes
-
Incidence of Adverse Events in terms of changes in laboratory parameters
Time frame: 6 weeks
-
Incidence of Adverse Events in terms of electrocardiogram parameters
Time frame: 6 weeks
-
Incidence of Adverse Events in terms of vital signs
Time frame: 6 weeks
-
Incidence of Adverse Events in terms of physical examination findings
Time frame: 6 weeks
-
Apparent terminal half-life (t1/2)
Time frame: Days -1, 1, 5 and 9
Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg from plasma and urine
-
t1/2
Time frame: Days -1, 1, 7 and 8
Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
-
t1/2
Time frame: Days -1, 1 and 7
Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg from plasma and urine
Sponsors and collaborators
Lead sponsor
Ardea Biosciences, Inc.
Industry
Registry information
Official study title
A Phase 1, Randomized, Open-Label Study in Healthy Adult Male Subjects to Assess the Pharmacokinetics and Pharmacodynamics of RDEA3170
Important dates
- Study start
- 2015
- Primary completion
- 2015
- Study completion
- 2016
- First posted
- Nov 20, 2015
- Registry last updated
- Sep 2, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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