Clinical trial NCT02448368: RDEA3170 Tablet and Capsule Bioavailability Study
Official title: A Phase 1, Randomized, Open-Label, Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability and Food Effect of Various Formulations of RDEA3170
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-19
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules compared with RDEA3170 tablets.


Eligibility criteria: 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 of 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 cannot swallow multiple tablets or capsules.
* Subject has received any strong or moderate enzyme-inducing drug or product within 2 months prior to Day 1.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1, 5, 9, 13, 17
measure: Time of Occurrence of Maximum Observed Concentration (Tmax)
timeFrame: Day 1, 5, 9, 13, 17
measure: Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)
timeFrame: Day 1, 5, 9, 13, 17
measure: Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)
timeFrame: Day 1, 5, 9, 13, 17
measure: Apparent Terminal Half-life (t1/2)
timeFrame: Day 1, 5, 9, 13, 17
measure: Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules
timeFrame: Day 1, 5, 9, 13, 17
measure: AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules
timeFrame: Day 1, 5, 9, 13, 17
measure: AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules
timeFrame: Day 1, 5, 9, 13, 17
Secondary outcomes:
measure: Pharmacodynamics (PD) Profile of RDEA3170
timeFrame: Day -1, 1, 5, 9, 13, 17
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
affiliation: Ardea Biosciences, Inc.
name: J Hall, MD
role: STUDY_DIRECTOR
References: