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Completed

NCT Number: NCT02448368

RDEA3170 Tablet and Capsule Bioavailability Study

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

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Key information

Conditions

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 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.

Treatment and study plan

RDEA3170,10 mg

Drug

Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.

Other names: Cohort 1

RDEA3170, 2.5 mg

Drug

Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.

Other names: Cohort 1

RDEA3170, 5 mg

Drug

Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.

Other names: Cohort 1

RDEA3170, 10 mg

Drug

Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.

Other names: Cohort 3

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Day 1, 5, 9, 13, 17

    Cmax is the maximum observed concentration of a drug after administration

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

    Time frame: Day 1, 5, 9, 13, 17

    Tmax is the time of occurrence of cmax

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

    Time frame: Day 1, 5, 9, 13, 17

    AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint

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

    Time frame: Day 1, 5, 9, 13, 17

    AUC 0-∞ is a meausre of total concentration from time zero to infinity

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

    Time frame: Day 1, 5, 9, 13, 17

    t1/2 is a measure of apparent terminal half-life

  6. Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules

    Time frame: Day 1, 5, 9, 13, 17

    Cmax is the maximum observed concentration of a drug after administration

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

    Time frame: Day 1, 5, 9, 13, 17

    AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint

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

    Time frame: Day 1, 5, 9, 13, 17

    AUC 0-∞ is a meausre of total concentration from time zero to infinity

Secondary outcomes

  1. Pharmacodynamics (PD) Profile of RDEA3170

    Time frame: Day -1, 1, 5, 9, 13, 17

    Serum samples were collected at the following timepoints in relation to RDEA3170 dosing: Day 1 (Cohort 1 and Cohort 3): -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours prior to dosing. Days 1, 5, and 9 (Cohort 1 and Cohort 3), and Days 13 and 17 (Cohort 1 only): predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose. Urine samples (total catch) were collected at the following timepoints in relation to RDEA3170 dosing: Day 1 (Cohort 1 and Cohort 3): -24 to -21, -21 to -18, -18 to -12, and -12 to 0 hours predose. Days 1, 5, and 9 (Cohort 1 and Cohort 3), and Days 13 and 17 (Cohort 1 only): 0 to 3, 3 to 6, 6 to 12, and 12 to 24 hours postdose.

  2. Incidence of Treatment-Emergent Adverse Events

    Time frame: 8 weeks

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 Relative Bioavailability and Food Effect of Various Formulations of RDEA3170

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
May 19, 2015
Registry last updated
Aug 20, 2018

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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