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Phase 1 Completed N=78 Randomized Basic Science

Phase 1, Febuxostat XR Relative Bioavailability Study

Healthy Volunteers
Source: ClinicalTrials.gov NCT02504320 ↗
Enrolled (actual)
78
Serious AEs
0.3%
Results posted
Jan 2017
Primary outcomePrimary: Mean Cmax: Maximum Observed Plasma Concentration for Febuxostat — 2027.1184; 1442.2267; 1730.2468; 1809.3158 ng/mL

Summary

This study will assess the relative bioavailability, safety and tolerability following administration of 80 mg single oral doses of 4 febuxostat extended release (XR) formulations.

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Cmax: Maximum Observed Plasma Concentration for Febuxostat
2027.1184; 1442.2267; 1730.2468; 1809.3158
PRIMARY
Mean AUCt: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Febuxostat
9395.6014; 7971.0624; 8652.7080; 8817.3600
PRIMARY
Mean AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat
9368.0744; 8278.6143; 8938.8765; 9102.3700

Eligibility Criteria

Inclusion Criteria

  • In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  • The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.
  • Is a healthy male or female and aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
  • Weighs at least 50.0 kg and has a body mass index (BMI) from 18.0 to 30.0 kg/m2, inclusive at Screening.
  • A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after the last dose.
  • A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent,
  • Is willing to refrain from strenuous exercise from Day -1 of Period 1 until Study Exit (Day 3 of Period 4).
  • Has estimated glomerular filtration rate (eGFR) ≥90 mL/min at Screening and Check-in (Day -1 of Period 1).

Exclusion Criteria

  • Has received any investigational compound within 30 days prior to the first dose of study medication.
  • Has received febuxostat in a previous clinical study or as a therapeutic agent.
  • Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in the conduct of this study.
  • Has uncontrolled, clinically significant (CS) disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
  • Has a known hypersensitivity to any component of the formulation of XO inhibitors, xanthine compounds, caffeine, or any component of the formulation of febuxostat capsules.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02504320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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