Clinical trial NCT02608710: RDEA3170 PK/PD Study
Official title: A Phase 1, Randomized, Open-Label Study in Healthy Adult Male Subjects to Assess the Pharmacokinetics and Pharmacodynamics of RDEA3170
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-20
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Days -1, 1, 5 and 9
measure: Cmax
timeFrame: Days -1, 1 and 7
measure: Cmax
timeFrame: Days -1, 1, 7 and 8
measure: Time of Occurrence of maximum observed concentration (Tmax)
timeFrame: Days -1, 1, 5 and 9
measure: Area under the plasma concentration time curve (AUC)
timeFrame: Days -1, 1, 5 and 9
measure: Tmax
timeFrame: Days -1, 1 and 7
measure: AUC
timeFrame: Days -1, 1 and 7
measure: Tmax
timeFrame: Days -1, 1, 7 and 8
measure: AUC
timeFrame: Days -1, 1, 7 and 8
measure: Serum urate concentration
timeFrame: Days -1, 1, 5 and 9
measure: Urine uric acid excretion amount
timeFrame: Days -1, 1, 5 and 9
measure: Renal clearance of uric acid
timeFrame: Days -1, 1, 5 and 9
measure: Fractional excretion of uric acid
timeFrame: Days -1, 1, 5 and 9
measure: Serum urate concentration
timeFrame: Days -1, 1 and 7
measure: Urine uric acid excretion amount
timeFrame: Days -1, 1 and 7
measure: Renal clearance of uric acid
timeFrame: Days -1, 1 and 7
measure: Fractional excretion of uric acid
timeFrame: Days -1, 1 and 7
measure: Serum urate concentration
timeFrame: Days -1, 1, 7 and 8
measure: Urine uric acid excretion amount
timeFrame: Days -1, 1, 7 and 8
measure: Renal Clearance of Uric Acid
timeFrame: Days -1, 1, 7 and 8
measure: Fractional excretion of uric acid
timeFrame: Days -1, 1, 7 and 8
Secondary outcomes:
measure: Incidence of Adverse Events in terms of changes in laboratory parameters
timeFrame: 6 weeks
measure: Incidence of Adverse Events in terms of electrocardiogram parameters
timeFrame: 6 weeks
measure: Incidence of Adverse Events in terms of vital signs
timeFrame: 6 weeks
measure: Incidence of Adverse Events in terms of physical examination findings
timeFrame: 6 weeks
measure: Apparent terminal half-life (t1/2)
timeFrame: Days -1, 1, 5 and 9
measure: t1/2
timeFrame: Days -1, 1, 7 and 8
measure: t1/2
timeFrame: Days -1, 1 and 7
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
affiliation: Ardea Biosciences, Inc.
name: J. Hall, MD
role: STUDY_DIRECTOR
References: