Healthy VolunteersPhase 1NCT02504320

Phase 1, Febuxostat XR Relative Bioavailability Study

A Phase 1 study testing Febuxostat XR 80 mg Capsule F1, Febuxostat XR 80 mg Capsule F2 and Febuxostat XR 80 mg Capsule F3 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

Search all trials

Trial summary

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. 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 80 mg Capsule F1, Febuxostat XR 80 mg Capsule F2 and Febuxostat XR 80 mg Capsule F3
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 1 siteUnited States
Study dates: Aug 2015to Oct 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

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).

Who cannot join

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.

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, Randomized, Open-Label, Single-Dose, 4-Way Crossover Study to Assess the Relative Bioavailability of Four 80 mg Febuxostat XR Formulations

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.

Read the detailed description

The drug being tested is this study is febuxostat XR. Four different formulations of febuxostat XR are being tested to see how the drug moves through the body. This study will look at safety and side effects in people who take febuxostat XR.

This cross-over study will enroll approximately 78 patients. Participants will be randomly assigned to 1of 4 sequences which will determine the order of the 4 treatments received:

Febuxostat XR 80 mg capsule Formulation 1
Febuxostat XR 80 mg capsule Formulation 2
Febuxostat XR 80 mg capsule Formulation 3
Febuxostat XR 80 mg capsule Formulation 4

Participants will take 1 dose on Day 1 with a washout period between each period.

This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 80 days. Participants will make multiple visits to the clinic including a period of confinement, 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 80 mg Capsule F1, Febuxostat XR 80 mg Capsule F2, Febuxostat XR 80 mg Capsule F3, Febuxostat XR 80 mg Capsule F4
Keywords: Drug therapy

What participants receive

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

Febuxostat XR 80 mg Capsule F1Drug
Febuxostat extended-release (XR) capsules formulation 1
Febuxostat XR 80 mg Capsule F2Drug
Febuxostat XR capsules formulation 2
Febuxostat XR 80 mg Capsule F3Drug
Febuxostat XR capsules formulation 3
Febuxostat XR 80 mg Capsule F4Drug
Febuxostat XR capsules formulation 4

Study groups in NCT02504320
Study group	Role	What they receive
Treatment Sequence ABDC	Experimental	Febuxostat XR 80 mg capsule Formulation 1 (F1), orally, once on Day 1 of Period 1 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 2 (F2), orally, once on Day 1 of Period 2 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 4 (F4), orally, once on Day 1 of Period 3 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 3 (F3), orally, once on Day 1 of Period 4 (C). Receives: Drug: Febuxostat XR 80 mg Capsule F1; Drug: Febuxostat XR 80 mg Capsule F2; Drug: Febuxostat XR 80 mg Capsule F3; Drug: Febuxostat XR 80 mg Capsule F4
Treatment Sequence DACB	Experimental	Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 1 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1 orally, once on Day 1 of Period 2 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 3 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 4 (B). Receives: Drug: Febuxostat XR 80 mg Capsule F1; Drug: Febuxostat XR 80 mg Capsule F2; Drug: Febuxostat XR 80 mg Capsule F3; Drug: Febuxostat XR 80 mg Capsule F4
Treatment Sequence CDBA	Experimental	Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 1 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4 orally, once on Day 1 of Period 2 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 3 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 4 (A). Receives: Drug: Febuxostat XR 80 mg Capsule F1; Drug: Febuxostat XR 80 mg Capsule F2; Drug: Febuxostat XR 80 mg Capsule F3; Drug: Febuxostat XR 80 mg Capsule F4
Treatment Sequence BCAD	Experimental	Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 1 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3 orally, once on Day 1 of Period 2 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 3 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 4 (D). Receives: Drug: Febuxostat XR 80 mg Capsule F1; Drug: Febuxostat XR 80 mg Capsule F2; Drug: Febuxostat XR 80 mg Capsule F3; Drug: Febuxostat XR 80 mg Capsule F4

What is being measured

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

Mean Cmax: Maximum Observed Plasma Concentration for Febuxostat
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Mean AUCt: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Febuxostat
AUCt is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration.
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Mean AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat
AUC∞ is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

Timeline

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

Aug 2015Oct 2015

First posted21 Jul 2015 (estimated)
Study startAug 2015
Primary completionSep 2015
Study completionOct 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02504320
Sponsor's protocol ID: Febuxostat XR-1011
Other IDs: U1111-1168-1117
Status last verified: Nov 2016
First submitted: 20 Jul 2015
Last updated: 19 Jan 2017
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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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Open-Label, Single-Dose, 4-Way Crossover Study to Assess the Relative Bioavailability of Four 80 mg Febuxostat XR Formulations
ClinicalTrials.gov ID: NCT02504320
Acronym / sponsor ID: Febuxostat XR-1011
Conditions: Healthy Volunteers
Keywords: Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Aug 2015
Primary completion: Sep 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 21 Jul 2015 (estimated)
Results: Posted 19 Jan 2017

Clinical summary

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

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.

Detailed description

This cross-over study will enroll approximately 78 patients. Participants will be randomly assigned to 1of 4 sequences which will determine the order of the 4 treatments received:

Febuxostat XR 80 mg capsule Formulation 1
Febuxostat XR 80 mg capsule Formulation 2
Febuxostat XR 80 mg capsule Formulation 3
Febuxostat XR 80 mg capsule Formulation 4

Participants will take 1 dose on Day 1 with a washout period between each period.

Study design

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

Arm	Type	Receives
Treatment Sequence ABDC	Experimental	Drug: Febuxostat XR 80 mg Capsule F1, Drug: Febuxostat XR 80 mg Capsule F2, Drug: Febuxostat XR 80 mg Capsule F3, Drug: Febuxostat XR 80 mg Capsule F4Febuxostat XR 80 mg capsule Formulation 1 (F1), orally, once on Day 1 of Period 1 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 2 (F2), orally, once on Day 1 of Period 2 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 4 (F4), orally, once on Day 1 of Period 3 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 3 (F3), orally, once on Day 1 of Period 4 (C).
Treatment Sequence DACB	Experimental	Drug: Febuxostat XR 80 mg Capsule F1, Drug: Febuxostat XR 80 mg Capsule F2, Drug: Febuxostat XR 80 mg Capsule F3, Drug: Febuxostat XR 80 mg Capsule F4Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 1 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1 orally, once on Day 1 of Period 2 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 3 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 4 (B).
Treatment Sequence CDBA	Experimental	Drug: Febuxostat XR 80 mg Capsule F1, Drug: Febuxostat XR 80 mg Capsule F2, Drug: Febuxostat XR 80 mg Capsule F3, Drug: Febuxostat XR 80 mg Capsule F4Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 1 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4 orally, once on Day 1 of Period 2 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 3 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 4 (A).
Treatment Sequence BCAD	Experimental	Drug: Febuxostat XR 80 mg Capsule F1, Drug: Febuxostat XR 80 mg Capsule F2, Drug: Febuxostat XR 80 mg Capsule F3, Drug: Febuxostat XR 80 mg Capsule F4Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 1 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3 orally, once on Day 1 of Period 2 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 3 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 4 (D).

Who may qualify

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

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (5 listed)

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.

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 XR 80 mg Capsule F1Febuxostat extended-release (XR) capsules formulation 1	Drug	Treatment Sequence ABDC, Treatment Sequence BCAD, Treatment Sequence CDBA, Treatment Sequence DACB
Febuxostat XR 80 mg Capsule F2Febuxostat XR capsules formulation 2	Drug	Treatment Sequence ABDC, Treatment Sequence BCAD, Treatment Sequence CDBA, Treatment Sequence DACB
Febuxostat XR 80 mg Capsule F3Febuxostat XR capsules formulation 3	Drug	Treatment Sequence ABDC, Treatment Sequence BCAD, Treatment Sequence CDBA, Treatment Sequence DACB
Febuxostat XR 80 mg Capsule F4Febuxostat XR capsules formulation 4	Drug	Treatment Sequence ABDC, Treatment Sequence BCAD, Treatment Sequence CDBA, Treatment Sequence DACB

Primary outcome

Mean Cmax: Maximum Observed Plasma Concentration for Febuxostat
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Mean AUCt: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Febuxostat
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUCt is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration.
Mean AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUC∞ is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.

Results and safety

Results posted to the registry on 19 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence ABDC	19	19
Treatment Sequence DACB	19	19
Treatment Sequence CDBA	20	19
Treatment Sequence BCAD	20	20

Primary outcome: Mean Cmax: Maximum Observed Plasma Concentration for Febuxostat

Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Regimen A: Febuxostat XR 80 mg Formulation 1 n = 76	Regimen B: Febuxostat XR 80 mg Formulation 2 n = 74	Regimen C: Febuxostat XR 80 mg Formulation 3 n = 77	Regimen D: Febuxostat XR 80 mg Formulation 4 n = 76
Value	2027.1184 (1278.28368)	1442.2267 (991.94583)	1730.2468 (1013.56204)	1809.3158 (1170.53245)

Regimen A: Febuxostat XR 80 mg Formulation 1 vs Regimen D: Febuxostat XR 80 mg Formulation 4: Point Estimate: 1.0848 (90% CI 0.9528 to 1.2350)
Regimen B: Febuxostat XR 80 mg Formulation 2 vs Regimen D: Febuxostat XR 80 mg Formulation 4: Point Estimate: 0.7709 (90% CI 0.6767 to 0.8782)
Regimen C: Febuxostat XR 80 mg Formulation 3 vs Regimen D: Febuxostat XR 80 mg Formulation 4: Point Estimate: 0.9389 (90% CI 0.8246 to 1.0689)

Population analysed: Participants with valid parameters for Regimen D and at least one of the test regimen were included in the analyses for this outcome measure. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.

Primary outcome: Mean AUCt: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Febuxostat

Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Regimen A: Febuxostat XR 80 mg Formulation 1 n = 76	Regimen B: Febuxostat XR 80 mg Formulation 2 n = 75	Regimen C: Febuxostat XR 80 mg Formulation 3 n = 77	Regimen D: Febuxostat XR 80 mg Formulation 4 n = 76
Value	9395.6014 (3961.55203)	7971.0624 (3291.36390)	8652.7080 (3673.91666)	8817.3600 (3429.94880)

Regimen A: Febuxostat XR 80 mg Formulation 1 vs Regimen D: Febuxostat XR 80 mg Formulation 4: Point Estimate: 1.0435 (90% CI 0.9840 to 1.1066)
Regimen B: Febuxostat XR 80 mg Formulation 2 vs Regimen D: Febuxostat XR 80 mg Formulation 4: Point Estimate: 0.8777 (90% CI 0.8274 to 0.9311)
Regimen C: Febuxostat XR 80 mg Formulation 3 vs Regimen D: Febuxostat XR 80 mg Formulation 4: Point Estimate: 0.9540 (90% CI 0.8996 to 1.0117)

Primary outcome: Mean AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat

Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Regimen A: Febuxostat XR 80 mg Formulation 1 n = 69	Regimen B: Febuxostat XR 80 mg Formulation 2 n = 62	Regimen C: Febuxostat XR 80 mg Formulation 3 n = 69	Regimen D: Febuxostat XR 80 mg Formulation 4 n = 69
Value	9368.0744 (3944.01280)	8278.6143 (3205.31556)	8938.8765 (3746.60153)	9102.3700 (3430.45699)

Regimen A: Febuxostat XR 80 mg Formulation 1 vs Regimen D: Febuxostat XR 80 mg Formulation 4: Point Estimate: 1.0283 (90% CI 0.9691 to 1.0911)
Regimen B: Febuxostat XR 80 mg Formulation 2 vs Regimen D: Febuxostat XR 80 mg Formulation 4: Point Estimate: 0.9056 (90% CI 0.8516 to 0.9630)
Regimen C: Febuxostat XR 80 mg Formulation 3 vs Regimen D: Febuxostat XR 80 mg Formulation 4: Point Estimates: 0.9463 (90% CI 0.8909 to 1.0051)

Adverse events

Time frame: From the first administration of study drug on Day 1 of Period 1 up to 30 days after the last dose of study drug or Early termination visit (approximately up to 95 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Regimen A: Febuxostat XR 80 mg Formulation 1	0 of 76 (0%)	6 of 76 (7.9%)	Not reported
Regimen B: Febuxostat XR 80 mg Formulation 2	1 of 76 (1.3%)	9 of 76 (11.8%)	Not reported
Regimen C: Febuxostat XR 80 mg Formulation 3	0 of 77 (0%)	7 of 77 (9.1%)	Not reported
Regimen D: Febuxostat XR 80 mg Formulation 4	0 of 76 (0%)	7 of 76 (9.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
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 80 mg Capsule F1, Febuxostat XR 80 mg Capsule F2 and Febuxostat XR 80 mg Capsule F3 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 8 inclusion and 5 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 19 Jan 2017. 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 19 Jan 2017). 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?

Mean Cmax: Maximum Observed Plasma Concentration for Febuxostat (time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose). The study lists 3 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 NCT02504320.

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 19 Jan 2017.