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Completed

NCT Number: NCT02382640

Effect of Antacid on Bioavailability of Febuxostat After Administration of a Febuxostat 80 mg Extended-Release Capsule

The purpose of this study is to assess the effect of antacid administration, and its timing, on the bioavailability of a single dose of febuxostat extended-release (XR) 80 mg.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Austin, Texas, 78744, United States

About this study

The drug being tested in this study is called febuxostat extended-release (XR). Febuxostat XR is being tested to assess if antacids affect how the drug moves throughout the body. This study will look at lab safety and side effects in people who take febuxostat XR.

This cross-over study will enroll approximately 36 patients. Participants will be randomly assigned to one of four treatment sequences. All participants will receive the following study medications by the end of the study:

  • Febuxostat XR 80 mg capsules
  • Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg/5 mL or equivalent

All participants will be administered one dose of one or both of the study medications on Day 1 of four separate study periods.

This single-centre trial will be conducted in the United States. The overall time to participate in this study is up to 84 days. Participants will make 5 visits to the clinic including four 4-day periods of confinement to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Is a healthy adult male or female aged 18 to 55 years, inclusive, by check-in (Day-1 of Period 1)
  • Weighs at least 50 kg (110 pounds), and has a body mass index (BMI) between 18.0 kg/m^2 to 30 kg/m^2, inclusive at Screening.
  • Has estimated glomerular filtration rate ≥90 mL/min

Exclusion criteria

Any participant who meets any of the following criteria will not qualify for entry into the study:

  • 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.
  • Has a known hypersensitivity to any xanthine oxidase inhibitor, xanthine compounds or any component of the formulation of febuxostat tablets (see Package Insert) or to caffeine.
  • Has a known hypersensitivity to aluminum, magnesium hydroxide, or any component of the formulation of antacid (Maalox Advanced Regular Strength or equivalent) (see Package Insert).
  • Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period.
  • Has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis frequent [more than once per week] occurrence of heartburn, or any surgical intervention [eg, cholecystectomy]).

Treatment and study plan

Febuxostat XR

Drug

Febuxostat extended-release (XR) capsules

Maalox Advance Regular Strength liquid

Drug

Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg/5 mL or equivalent

Primary outcomes

  1. Cmax: Maximum Observed Plasma Concentration for Febuxostat

    Time frame: Days 1 at multiple timepoints (up to 48 hours) post-dose

  2. AUC(0-tau): Area Under the Plasma Concentration-time Curve During the Dosing Interval for Febuxostat

    Time frame: Days 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose

  3. AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat

    Time frame: Days 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose

  4. Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)

  5. Number of Participants With Clinically Significant Change From Baseline in Vital Signs

    Time frame: Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)

  6. Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings

    Time frame: Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)

  7. Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Evaluation

    Time frame: Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)

  8. Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG)

    Time frame: Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

A Phase 1, Open-Label, Single Center, Single-Dose, Randomized, 4-Way Crossover Study to Assess the Effect of an Antacid on the Bioavailability of Febuxostat After Oral Administration of a 80 mg Febuxostat Extended-Release (XR) Capsule Formulation

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 9, 2015
Registry last updated
Apr 29, 2016

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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