Healthy VolunteersPhase 1NCT02382640

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

A Phase 1 study testing Febuxostat XR and Maalox Advance Regular Strength liquid in people with Healthy Volunteers, run by Takeda at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Febuxostat XR and Maalox Advance Regular Strength liquid
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: Mar 2015to May 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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]).

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Austin, Texas, 78744

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Healthy Volunteers
Being tested: Febuxostat XR, Maalox Advance Regular Strength liquid
Keywords: Drug therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Febuxostat XRDrug
Febuxostat extended-release (XR) capsules
Maalox Advance Regular Strength liquidDrug
Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg/5 mL or equivalent

Study groups in NCT02382640
Study group	Role	What they receive
Sequence 1: ABDC	Experimental	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). Receives: Drug: Febuxostat XR; Drug: Maalox Advance Regular Strength liquid
Sequence 2: DACB	Experimental	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. Receives: Drug: Febuxostat XR; Drug: Maalox Advance Regular Strength liquid
Sequence 3: CDBA	Experimental	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. Receives: Drug: Febuxostat XR; Drug: Maalox Advance Regular Strength liquid
Sequence 4: BCAD	Experimental	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. Receives: Drug: Febuxostat XR; Drug: Maalox Advance Regular Strength liquid

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax: Maximum Observed Plasma Concentration for Febuxostat
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015May 2015

First posted9 Mar 2015 (estimated)
Study startMar 2015
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02382640
Sponsor's protocol ID: Febuxostat XR-1010
Other IDs: U1111-1163-1813
Status last verified: Mar 2016
First submitted: 3 Mar 2015
Last updated: 29 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02382640
Acronym / sponsor ID: Febuxostat XR-1010
Conditions: Healthy Volunteers
Keywords: Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Mar 2015
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 9 Mar 2015 (estimated)
Results: Posted 29 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Sequence 1: ABDC	Experimental	Drug: Febuxostat XR, Drug: Maalox Advance Regular Strength liquidExperimental: 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).
Sequence 2: DACB	Experimental	Drug: Febuxostat XR, Drug: Maalox Advance Regular Strength liquidExperimental: 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.
Sequence 3: CDBA	Experimental	Drug: Febuxostat XR, Drug: Maalox Advance Regular Strength liquidFebuxostat 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.
Sequence 4: BCAD	Experimental	Drug: Febuxostat XR, Drug: Maalox Advance Regular Strength liquidMaalox 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Febuxostat XRFebuxostat extended-release (XR) capsules	Drug	Sequence 1: ABDC, Sequence 2: DACB, Sequence 3: CDBA, Sequence 4: BCAD
Maalox Advance Regular Strength liquidMaalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg/5 mL or equivalent	Drug	Sequence 1: ABDC, Sequence 2: DACB, Sequence 3: CDBA, Sequence 4: BCAD

Primary outcome

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)

Results and safety

Results posted to the registry on 29 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Regimen A, Then B, Then D, Then C	9	9
Regimen D, Then A, Then C, Then B	9	9
Regimen C, Then D, Then B, Then A	9	9
Regimen B, Then C, Then A, Then D	9	9

Primary outcome: Cmax: Maximum Observed Plasma Concentration for Febuxostat

Time frame: Days 1 at multiple timepoints (up to 48 hours) post-dose. Mean (Standard Deviation). Unit: nanogram per milliliter (ng/mL)

Measure	Regimen A n = 36	Regimen B n = 36	Regimen C n = 35	Regimen D n = 36
Value	883.58 (898.49)	1075.08 (941.46)	765.89 (480.2)	1456.42 (875.39)

Population analysed: The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.

Primary outcome: 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. Mean (Standard Deviation). Unit: nanogram*hour per milliliter (ng*hr/mL)

Measure	Regimen A n = 36	Regimen B n = 36	Regimen C n = 35	Regimen D n = 36
Value	4680.69 (2427.11)	5877.99 (2888.9)	4412.22 (1718.42)	7316.21 (2811.1)

Population analysed: The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.

Primary outcome: 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. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Regimen A n = 36	Regimen B n = 36	Regimen C n = 35	Regimen D n = 36
Value	5901 (2739.92)	6999.9 (2912.71)	4844.33 (1918.73)	7697.85 (2732.63)

Population analysed: The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.

Primary outcome: 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. Unit: participants

Measure	Regimen A n = 36	Regimen B n = 36	Regimen C n = 35	Regimen D n = 36
TEAE	2	1	3	2
SAE	0	0	0	0

Population analysed: The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Regimen A	0 of 36 (0%)	2 of 36 (5.6%)	Not reported
Regimen B	0 of 36 (0%)	1 of 36 (2.8%)	Not reported
Regimen C	0 of 35 (0%)	3 of 35 (8.6%)	Not reported
Regimen D	0 of 36 (0%)	2 of 36 (5.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director Clinical Science study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Febuxostat XR and Maalox Advance Regular Strength liquid in people with Healthy Volunteers, run by Takeda at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax: Maximum Observed Plasma Concentration for Febuxostat (time frame: Days 1 at multiple timepoints (up to 48 hours) post-dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02382640.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2016.