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Trial record 1 of 1 for:    Febuxostat XR-1010
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Effect of Antacid on Bioavailability of Febuxostat After Administration of a Febuxostat 80 mg Extended-Release Capsule

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02382640
First received: March 3, 2015
Last updated: March 28, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Healthy Volunteers Drug: Febuxostat XR Drug: Maalox Advance Regular Strength liquid Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Cmax: Maximum Observed Plasma Concentration for Febuxostat [ Time Frame: Days 1 at multiple timepoints (up to 48 hours) post-dose ]
  • 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 ]
  • 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 ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]

Enrollment: 36
Study Start Date: March 2015
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1: ABDC
Experimental: Sequence 1: ABDC Febuxostat 80 mg extended-release (XR) capsule, orally, once, after a 10-hour fast, and 20 mL Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg/5 mL (hereafter referred as Maalox) or equivalent, orally, once, after a 10-hour fast, on Day 1 of Period 1 (A), followed by a 7-day washout period, followed by Maalox or equivalent, orally, once, after a 9-hour fast, and febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast (1 hour after Maalox or equivalent), on Day 1 of Period 2 (B), followed by a 7-day washout period, followed by febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast, on Day 1 of Period 3 (D), followed by a 7-day washout period, followed by febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast, and Maalox or equivalent, orally, once, after an 11-hour fast (1 hour after febuxostat), on Day 1 of Period 4 (C).
Drug: Febuxostat XR
Febuxostat extended-release (XR) capsules
Drug: Maalox Advance Regular Strength liquid
Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg/5 mL or equivalent
Experimental: Sequence 2: DACB
Experimental: Sequence 2: DACB Febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast, on Day 1 of Period 1, followed by a 7-day washout period, followed by febuxostat 80 mg extended-release (XR) capsule, orally, once, after a 10-hour fast, and Maalox or equivalent, orally, once, after a 10-hour fast, on Day 1 of Period 2, followed by a 7-day washout period, followed by febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast, and Maalox or equivalent, orally, once, after an 11-hour fast (1 hour after febuxostat), on Day 1 of Period 3, followed by a 7-day washout period, followed by Maalox or equivalent, orally, once, after a 9-hour fast, and febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast (1 hour after Maalox or equivalent), on Day 1 of Period 4.
Drug: Febuxostat XR
Febuxostat extended-release (XR) capsules
Drug: Maalox Advance Regular Strength liquid
Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg/5 mL or equivalent
Experimental: Sequence 3: CDBA
Febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast, and Maalox or equivalent, orally, once, after an 11-hour fast (1 hour after febuxostat), on Day 1 of Period 1, followed by a 7-day washout period, followed by febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast, on Day 1 of Period 2, followed by a 7-day washout period, followed by Maalox or equivalent, orally, once, after a 9-hour fast, and febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast (1 hour after Maalox or equivalent), on Day 1 of Period 3, followed by a 7-day washout period, followed by Febuxostat 80 mg extended-release (XR) capsule, orally, once, after a 10-hour fast, and Maalox or equivalent, orally, once, after a 10-hour fast, on Day 1 of Period 4.
Drug: Febuxostat XR
Febuxostat extended-release (XR) capsules
Drug: Maalox Advance Regular Strength liquid
Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg/5 mL or equivalent
Experimental: Sequence 4: BCAD
Maalox or equivalent, orally, once, after a 9-hour fast, and febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast (1 hour after Maalox), on Day 1 of Period 1, followed by a 7-day washout period, followed by febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast, and Maalox or equivalent, orally, once, after an 11-hour fast (1 hour after febuxostat), on Day 1 of Period 2, followed by a 7-day washout period, followed by febuxostat 80 mg extended-release (XR) capsule, orally, once, after a 10-hour fast, and Maalox or equivalent, orally, once, after a 10-hour fast, on Day 1 of Period 3, followed by a 7-day washout period, followed by febuxostat 80 mg XR capsule, orally, once, after a 10-hour fast, on Day 1 of Period 4.
Drug: Febuxostat XR
Febuxostat extended-release (XR) capsules
Drug: Maalox Advance Regular Strength liquid
Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg/5 mL or equivalent

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Is a healthy adult male or female aged 18 to 55 years, inclusive, by check-in (Day-1 of Period 1)
  2. 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.
  3. 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:

  1. Has received any investigational compound within 30 days prior to the first dose of study medication.
  2. Has received febuxostat in a previous clinical study or as a therapeutic agent.
  3. 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.
  4. 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).
  5. 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.
  6. 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]).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02382640

Locations
United States, Texas
Austin, Texas, United States, 78744
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Clinical Science Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02382640     History of Changes
Other Study ID Numbers: Febuxostat XR-1010
U1111-1163-1813 ( Registry Identifier: WHO )
Study First Received: March 3, 2015
Results First Received: March 28, 2016
Last Updated: March 28, 2016

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Febuxostat
Aluminum Hydroxide
Antacids
Aluminum hydroxide, magnesium hydroxide, drug combination
Magnesium Hydroxide
Gout Suppressants
Antirheumatic Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 18, 2017