HealthyPhase 1NCT02581553

Lesinurad/Allopurinol 200/300 FDC Tablets Bioavailability

A Phase 1 study testing lesinurad/allopurinol 200/300 FDC tablets, lesinurad 200 mg and allopurinol 300 mg in people with Healthy, run by Ardea Biosciences, Inc. 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

This study will assess relative bioavailability of lesinurad/allopurinol fixed dose combination (FDC), its individual components and the effect of food. Read more about this study

Who is it for?: Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: lesinurad/allopurinol 200/300 FDC tablets, lesinurad 200 mg and allopurinol 300 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 116 participants
Where: 1 siteUnited States
Study dates: Oct 2015to Aug 2016
Phase: Phase 1
Are there results?: None posted in the registry

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 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Body mass index ranging between 18 kg/m2 and 40 kg/m2.
Screening serum urate level is ≤ 7.0 mg/dL.

Who cannot join

Asian subject who has a positive test for the HLA-B*5801 allele.
History or suspicion of kidney stones.
Estimated creatinine clearance, as determined at Screening, of < 90 mL/min calculated by the Cockcroft-Gault formula using ideal body weight.
Undergone major surgery within 3 months prior to Screening.
Donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1or has given a plasma donation within 4 weeks prior to Day 1.
Inadequate venous access or unsuitable veins for repeated venipuncture.
Received any strong or moderate enzyme-inducing drug or product within 2 months prior to Screening.

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, Crossover Study to Assess the Relative Bioavailability of Lesinurad/Allopurinol Fixed Dose Combination Tablets and Coadministered Lesinurad and Allopurinol Tablets and the Effect of Food on the Pharmacokinetics of Lesinurad/Allopurinol Fixed Dose Combination Tablets in Healthy Adult Male Subjects

This study will assess relative bioavailability of lesinurad/allopurinol fixed dose combination (FDC), its individual components and the effect of food.

Read the detailed description

The study comprises 2 parts. Part 1 will assess the relative BA of lesinurad/allopurinol FDC and monocomponents in fasted subjects. Part 2 will assess the effect of food on the PK of FDC tablets.

Conditions: Healthy
Being tested: lesinurad/allopurinol 200/300 FDC tablets, lesinurad 200 mg, allopurinol 300 mg, lesinurad/allopurinol 200/200 FDC tablets, allopurinol 200 mg

What participants receive

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

lesinurad/allopurinol 200/300 FDC tabletsDrug
lesinurad 200 mgDrug
allopurinol 300 mgDrug
lesinurad/allopurinol 200/200 FDC tabletsDrug
allopurinol 200 mgDrug

Study groups in NCT02581553
Study group	Role	What they receive
Sequence AB	Experimental	Day 1: lesinurad/allopurinol FDC tablets (Treatment A); Day 8: lesinurad + allopurinol (Treatment B) Receives: Drug: lesinurad/allopurinol 200/300 FDC tablets; Drug: lesinurad 200 mg; Drug: allopurinol 300 mg
Sequence BA	Experimental	Day 1: lesinurad + allopurinol (Treatment B); Day 8: lesinurad/allopurinol FDC tablets (Treatment A). Receives: Drug: lesinurad/allopurinol 200/300 FDC tablets; Drug: lesinurad 200 mg; Drug: allopurinol 300 mg
Sequence CD	Experimental	Day 1: lesinurad/allopurinol FDC tablets (Treatment C [fasted]); Day 8: lesinurad/allopurinol FDC tablets (Treatment D [fed]). Receives: Drug: lesinurad/allopurinol 200/300 FDC tablets
Sequence DC	Experimental	Day 1: lesinurad/allopurinol FDC tablets (Treatment D [fed]); Day 8: lesinurad/allopurinol FDC tablets (Treatment C [fasted]). Receives: Drug: lesinurad/allopurinol 200/300 FDC tablets
Sequence EF	Experimental	Day 1: lesinurad/allopurinol 200/200 FDC tablets (Treatment E); Day 8: coadministered lesinurad 200 mg + allopurinol 200 mg (100 mg × 2) Receives: Drug: lesinurad 200 mg; Drug: lesinurad/allopurinol 200/200 FDC tablets; Drug: allopurinol 200 mg
Sequence FE	Experimental	Day 1: coadministered lesinurad 200 mg + allopurinol 200 mg (100 mg × 2) (Treatment F); Day 8: lesinurad/allopurinol 200/200 FDC tablets (Treatment E). Receives: Drug: lesinurad 200 mg; Drug: lesinurad/allopurinol 200/200 FDC tablets; Drug: allopurinol 200 mg

What is being measured

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

Pharmacokinetics (PK) endpoints in terms of maximum observed concentration (Cmax) for lesinurad/allopurinol 200/300 and 200/200 FDC tablets relative to lesinurad and allopurinol monocomponent tablets
Cmax is the maximum observed concentration of a drug after administration
Measured: Days 1 and Day 8
PK endpoints in terms of time of occurrence of maximum observed concentration (tmax) for lesinurad/allopurinol 200/300 and 200/200 FDC tablets relative to lesinurad and allopurinol monocomponent tablets
Tmax is the time of occurrence of cmax
Measured: Day 1 and Day 8
PK endpoints in terms of area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint (AUC last) for lesinurad/allopurinol 200/300 and 200/200 FDC tablets relative to lesinurad and allopurinol monocomponent tablets
AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint
Measured: Day 1 and Day 8
PK endpoints in terms of area under the plasma concentration time curve from and from zero to infinity (AUC 0-∞) for lesinurad/allopurinol 200/300 and 200/200 FDC tablets relative to lesinurad and allopurinol monocomponent tablets
AUC 0-∞ is a meausre of total concentration from time zero to infinity
Measured: Day 1 and Day 8
PK endpoints in terms of apparent terminal half-life (t1/2) for lesinurad/allopurinol 200/300 and 200/200 FDC tablets relative to lesinurad and allopurinol monocomponent tablets
t1/2 is a measure of apparent terminal half-life
Measured: Day 1 and Day 8

Secondary outcomes (4)

Incidence of Adverse Events in terms of changes in laboratory parameters
Measured: 6 weeks
Incidence of Adverse Events in terms of electrocardiogram parameters
Measured: 6 weeks
Incidence of Adverse Events in terms of vital signs
Measured: 6 weeks
Incidence of Adverse Events in terms of physical examination findings
Measured: 6 weeks

Timeline

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

Oct 2015Aug 2016

First posted21 Oct 2015 (estimated)
Study startOct 2015
Primary completionJul 2016
Study completionAug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
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: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02581553
Sponsor's protocol ID: RDEA594-501
Status last verified: Dec 2016
First submitted: 12 Oct 2015
Last updated: 19 Dec 2016
Results posted: No
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 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Open-Label, Crossover Study to Assess the Relative Bioavailability of Lesinurad/Allopurinol Fixed Dose Combination Tablets and Coadministered Lesinurad and Allopurinol Tablets and the Effect of Food on the Pharmacokinetics of Lesinurad/Allopurinol Fixed Dose Combination Tablets in Healthy Adult Male Subjects
ClinicalTrials.gov ID: NCT02581553
Acronym / sponsor ID: RDEA594-501
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: Ardea Biosciences, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2015
Primary completion: Jul 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 21 Oct 2015 (estimated)
Results: Not posted in the source record

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 relative bioavailability of lesinurad/allopurinol fixed dose combination (FDC), its individual components and the effect of food.

Detailed description

The study comprises 2 parts. Part 1 will assess the relative BA of lesinurad/allopurinol FDC and monocomponents in fasted subjects. Part 2 will assess the effect of food on the PK of FDC tablets.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Sequence AB	Experimental	Drug: lesinurad/allopurinol 200/300 FDC tablets, Drug: lesinurad 200 mg, Drug: allopurinol 300 mgDay 1: lesinurad/allopurinol FDC tablets (Treatment A); Day 8: lesinurad + allopurinol (Treatment B)
Sequence BA	Experimental	Drug: lesinurad/allopurinol 200/300 FDC tablets, Drug: lesinurad 200 mg, Drug: allopurinol 300 mgDay 1: lesinurad + allopurinol (Treatment B); Day 8: lesinurad/allopurinol FDC tablets (Treatment A).
Sequence CD	Experimental	Drug: lesinurad/allopurinol 200/300 FDC tabletsDay 1: lesinurad/allopurinol FDC tablets (Treatment C [fasted]); Day 8: lesinurad/allopurinol FDC tablets (Treatment D [fed]).
Sequence DC	Experimental	Drug: lesinurad/allopurinol 200/300 FDC tabletsDay 1: lesinurad/allopurinol FDC tablets (Treatment D [fed]); Day 8: lesinurad/allopurinol FDC tablets (Treatment C [fasted]).
Sequence EF	Experimental	Drug: lesinurad 200 mg, Drug: lesinurad/allopurinol 200/200 FDC tablets, Drug: allopurinol 200 mgDay 1: lesinurad/allopurinol 200/200 FDC tablets (Treatment E); Day 8: coadministered lesinurad 200 mg + allopurinol 200 mg (100 mg × 2)
Sequence FE	Experimental	Drug: lesinurad 200 mg, Drug: lesinurad/allopurinol 200/200 FDC tablets, Drug: allopurinol 200 mgDay 1: coadministered lesinurad 200 mg + allopurinol 200 mg (100 mg × 2) (Treatment F); Day 8: lesinurad/allopurinol 200/200 FDC tablets (Treatment E).

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Body mass index ranging between 18 kg/m2 and 40 kg/m2.
Screening serum urate level is ≤ 7.0 mg/dL.

Key exclusion criteria (7 listed)

Asian subject who has a positive test for the HLA-B*5801 allele.
History or suspicion of kidney stones.
Estimated creatinine clearance, as determined at Screening, of < 90 mL/min calculated by the Cockcroft-Gault formula using ideal body weight.
Undergone major surgery within 3 months prior to Screening.
Donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1or has given a plasma donation within 4 weeks prior to Day 1.

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
lesinurad/allopurinol 200/300 FDC tablets	Drug	Sequence AB, Sequence BA, Sequence CD, Sequence DC
lesinurad 200 mg	Drug	Sequence AB, Sequence BA, Sequence EF, Sequence FE
allopurinol 300 mg	Drug	Sequence AB, Sequence BA
lesinurad/allopurinol 200/200 FDC tablets	Drug	Sequence EF, Sequence FE
allopurinol 200 mg	Drug	Sequence EF, Sequence FE

Primary outcome

Pharmacokinetics (PK) endpoints in terms of maximum observed concentration (Cmax) for lesinurad/allopurinol 200/300 and 200/200 FDC tablets relative to lesinurad and allopurinol monocomponent tablets
Time frame: Days 1 and Day 8
Cmax is the maximum observed concentration of a drug after administration
PK endpoints in terms of time of occurrence of maximum observed concentration (tmax) for lesinurad/allopurinol 200/300 and 200/200 FDC tablets relative to lesinurad and allopurinol monocomponent tablets
Time frame: Day 1 and Day 8
Tmax is the time of occurrence of cmax
PK endpoints in terms of area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint (AUC last) for lesinurad/allopurinol 200/300 and 200/200 FDC tablets relative to lesinurad and allopurinol monocomponent tablets
Time frame: Day 1 and Day 8
AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint
PK endpoints in terms of area under the plasma concentration time curve from and from zero to infinity (AUC 0-∞) for lesinurad/allopurinol 200/300 and 200/200 FDC tablets relative to lesinurad and allopurinol monocomponent tablets
Time frame: Day 1 and Day 8
AUC 0-∞ is a meausre of total concentration from time zero to infinity
PK endpoints in terms of apparent terminal half-life (t1/2) for lesinurad/allopurinol 200/300 and 200/200 FDC tablets relative to lesinurad and allopurinol monocomponent tablets
Time frame: Day 1 and Day 8
t1/2 is a measure of apparent terminal half-life

4 secondary outcomes

Incidence of Adverse Events in terms of changes in laboratory parameters
Time frame: 6 weeks
Incidence of Adverse Events in terms of electrocardiogram parameters
Time frame: 6 weeks
Incidence of Adverse Events in terms of vital signs
Time frame: 6 weeks
Incidence of Adverse Events in terms of physical examination findings
Time frame: 6 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.

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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.

N. Bhakta study director

Ardea Biosciences, Inc.

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 lesinurad/allopurinol 200/300 FDC tablets, lesinurad 200 mg and allopurinol 300 mg in people with Healthy, run by Ardea Biosciences, Inc. 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 2 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 19 Dec 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Pharmacokinetics (PK) endpoints in terms of maximum observed concentration (Cmax) for lesinurad/allopurinol 200/300 and 200/200 FDC tablets relative to lesinurad and allopurinol monocomponent tablets (time frame: Days 1 and Day 8). The study lists 5 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 NCT02581553.

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 Dec 2016.