Phase 1
Completed N=36
Effect of Antacid on Bioavailability of Febuxostat After Administration of a Febuxostat 80 mg Extended-Release Capsule
Healthy Volunteers
Source: ClinicalTrials.gov NCT02382640 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: Cmax: Maximum Observed Plasma Concentration for Febuxostat — 883.58; 1075.08; 765.89; 1456.42 nanogram per milliliter (ng/mL)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Plasma Concentration for Febuxostat |
883.58; 1075.08; 765.89; 1456.42 | — |
| PRIMARY AUC(0-tau): Area Under the Plasma Concentration-time Curve During the Dosing Interval for Febuxostat |
4680.69; 5877.99; 4412.22; 7316.21 | — |
| PRIMARY AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat |
5901; 6999.9; 4844.33; 7697.85 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) |
2; 1; 3; 2; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in Vital Signs |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Evaluation |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) |
0; 0; 0; 0 | — |
Eligibility Criteria
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]).
Data sourced from ClinicalTrials.gov (NCT02382640). 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.