Phase 1, Febuxostat XR Relative Bioavailability Study

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT02504320

Run by

Takeda

People needed

78

Starts

2015-08-01

Expected to finish

2015-10-01

Last updated by the study team

2017-01-19

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Study site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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