Skip to main content
OpenTrials
Completed

NCT Number: NCT02336594

RDEA3170 Bioavailability Study

This is a Phase 1, randomized, open-label, 4-way crossover pharmacokinetic (PK) and pharmacodynamic (PD) study in healthy adult male subjects designed to assess the relative bioavailability of RDEA3170 2.5 mg tablets administered as a 10 mg dose (2.5 mg × 4 tablets) and of a single RDEA3170 10 mg tablet. This study will also assess the effect of a low-fat and high-fat meal on the PK and PD of RDEA3170 10 mg tablets.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 ≤ 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 (> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1
  • Subject has inadequate venous access or unsuitable veins for repeated venipuncture
  • Subject has a Screening serum creatinine value above the upper limit of normal during Screening or at Day -2 (Admission)
  • Subject cannot swallow multiple tablets
  • Subject is a heavy caffeine drinker
  • Subject is unwilling to comply with the dietary restrictions of the study
  • Subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study

Treatment and study plan

RDEA3170 10 mg

Drug

RDEA3170 2.5 mg

Drug

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

    Cmax of RDEA3170 in fasted condition.

  2. Time of Occurrence of Maximum Observed Concentration (Tmax)

    Time frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

    Tmax of RDEA3170 following various treatments.

  3. Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)

    Time frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

    AUC last of RDEA3170 in fasted condition.

  4. Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)

    Time frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

    AUC∞ of RDEA3170 the fasted condition.

  5. Apparent Terminal Half-life (t1/2)

    Time frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

    t1/2 of RDEA3170 following various treatments.

  6. Cmax: Effect of High Fat Meal on the PK of RDEA3170 Tablets

    Time frame: Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

    Cmax of RDEA3170 in high-fat fed state.

  7. AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Tablets

    Time frame: Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

    AUC last of RDEA3170 in high-fat fed state.

  8. AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Tablets

    Time frame: Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

    AUC∞ of RDEA3170 in high-fat fed state.

  9. Cmax: Effect of Low Fat Meal on the PK of RDEA3170 Tablets

    Time frame: Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

    Cmax of RDEA3170 in low-fat fed state.

  10. AUC Last: Effect of Low Fat Meal on the PK of RDEA3170 Tablets

    Time frame: Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

    AUC last of RDEA3170 in low-fat fed state.

  11. AUC∞: Effect of Low Fat Meal on the PK of RDEA3170 Tablets

    Time frame: Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

    AUC∞ of RDEA3170 in low-fat fed state.

Secondary outcomes

  1. Single Dose Pharmacodynamics (PD) Profile of RDEA3170 From Serum and Urine

    Time frame: Day -1: -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours predose. Days 1, 5, 9, and 13: predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose.

    PD profiles of uric acid from serum and urine. PD parameters were evaluated to assess whether any potential differences in PK for the 2 different tablets resulted in differences in uric acid excretion.

  2. Incidence of Treatment-Emergent Adverse Events

    Time frame: 7 weeks.

Sponsors and collaborators

Lead sponsor

Ardea Biosciences, Inc.

Industry

Registry information

Official study title

A Phase 1, Randomized, Open-Label, Crossover Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability of Two RDEA3170 Tablets

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 13, 2015
Registry last updated
Oct 13, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.