GoutPhase 1NCT01884272
NSAID Drug Interaction Study
A Phase 1 study testing lesinurad 400 mg, naproxen 250 mg and indomethacin 25 mg in people with Gout, run by Ardea Biosciences, Inc. at 1 site in United States.
Trial summary
This is a drug-drug interaction study in healthy volunteers to evaluate the potential pharmacokinetic (PK) effects of non-steroidal anti-inflammatory drugs on lesinurad and leinurad on the non-steroidal anti-inflammatory drugs. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gout
- What is being tested?
- lesinurad 400 mg, naproxen 250 mg and indomethacin 25 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Oct 2013
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject has a body weight ≥ 50 kg (110 lbs) and a body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
- Subject is free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
- Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values.
Who cannot join
- Subject has clinically significant pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
- Subject has a history or suspicion of kidney stones.
- Subject has a history of asthma.
- Subject has undergone major surgery within 3 months prior to Day 1.
- Subject has donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening visit.
- Subject has inadequate venous access or unsuitable veins for repeated venipuncture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Evaluate the Potential Two-Way Pharmacokinetic Interaction Between Lesinurad and Naproxen and Between Lesinurad and Indomethacin in Healthy Adult Male Subjects
This is a drug-drug interaction study in healthy volunteers to evaluate the potential pharmacokinetic (PK) effects of non-steroidal anti-inflammatory drugs on lesinurad and leinurad on the non-steroidal anti-inflammatory drugs.
Read the detailed description
Naproxen and indomethacin are non-steroidal anti-inflammatory drugs (NSAIDs) used both prophylactically for the prevention of, and as a treatment for, acute gout flares. RDEA594-126 is an open-label study designed to assess the potential effect of multiple doses of naproxen and indomethacin on the single-dose PK of lesinurad, and to assess the potential effect of multiple doses of lesinurad on the multiple-dose PK of naproxen and indomethacin.
- Conditions
- Gout
- Being tested
- lesinurad 400 mg, naproxen 250 mg, indomethacin 25 mg
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lesinurad 400 mgDrug
naproxen 250 mgDrug
indomethacin 25 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Lesinurad 400 mg and naproxen 250 mg | Experimental | Lesinurad once daily (qd) Day 1, naproxen twice daily (bid) Day 2-6, lesinurad qd with naproxen bid Day 7-14. Receives: Drug: lesinurad 400 mg; Drug: naproxen 250 mg |
| Lesinurad 400 mg and indomethacin 25 mg | Active comparator | Lesinurad qd Day 1, indomethacin bid Day 2-6, lesinurad qd with indomethacin bid Day 7-14. Receives: Drug: lesinurad 400 mg; Drug: indomethacin 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK profile of lesinurad from plasma and urine
Profile in terms of AUC, Tmax, Cmax, and t1/2 AUC: area under the plasma concentration versus time curve; Tmax: time to maximum plasma concentration; Cmax: maximum plasma drug concentration; t1/2: apparent terminal half-life
Measured: Day 1, Day 6 (urine only), Day 7, Day 14
PK profile of naproxen and indomethacin from plasma and urine
Profile in terms of AUC, Tmax, Cmax, and t1/2
Measured: Day 1, Day 6 (urine only), Day 7, Day 14
Secondary outcomes (1)
Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardea Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- S Bradley, MD, Study director, Ardea Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884272
- Sponsor's protocol ID
- RDEA594-126
- Status last verified
- Nov 2013
- First submitted
- 18 Jun 2013
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Potential Two-Way Pharmacokinetic Interaction Between Lesinurad and Naproxen and Between Lesinurad and Indomethacin in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT01884272
- Acronym / sponsor ID
- RDEA594-126
- Conditions
- Gout
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ardea Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 24 Jun 2013 (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 is a drug-drug interaction study in healthy volunteers to evaluate the potential pharmacokinetic (PK) effects of non-steroidal anti-inflammatory drugs on lesinurad and leinurad on the non-steroidal anti-inflammatory drugs.
Detailed description
Naproxen and indomethacin are non-steroidal anti-inflammatory drugs (NSAIDs) used both prophylactically for the prevention of, and as a treatment for, acute gout flares. RDEA594-126 is an open-label study designed to assess the potential effect of multiple doses of naproxen and indomethacin on the single-dose PK of lesinurad, and to assess the potential effect of multiple doses of lesinurad on the multiple-dose PK of naproxen and indomethacin.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lesinurad 400 mg and naproxen 250 mg | Experimental | Drug: lesinurad 400 mg, Drug: naproxen 250 mgLesinurad once daily (qd) Day 1, naproxen twice daily (bid) Day 2-6, lesinurad qd with naproxen bid Day 7-14. |
| Lesinurad 400 mg and indomethacin 25 mg | Active comparator | Drug: lesinurad 400 mg, Drug: indomethacin 25 mgLesinurad qd Day 1, indomethacin bid Day 2-6, lesinurad qd with indomethacin bid Day 7-14. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject has a body weight ≥ 50 kg (110 lbs) and a body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
- Subject is free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
- Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values.
Key exclusion criteria (6 listed)
- Subject has clinically significant pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
- Subject has a history or suspicion of kidney stones.
- Subject has a history of asthma.
- Subject has undergone major surgery within 3 months prior to Day 1.
- Subject has donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening visit.
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 400 mg | Drug | Lesinurad 400 mg and indomethacin 25 mg, Lesinurad 400 mg and naproxen 250 mg |
| naproxen 250 mg | Drug | Lesinurad 400 mg and naproxen 250 mg |
| indomethacin 25 mg | Drug | Lesinurad 400 mg and indomethacin 25 mg |
Primary outcome
PK profile of lesinurad from plasma and urine
Time frame: Day 1, Day 6 (urine only), Day 7, Day 14
Profile in terms of AUC, Tmax, Cmax, and t1/2 AUC: area under the plasma concentration versus time curve; Tmax: time to maximum plasma concentration; Cmax: maximum plasma drug concentration; t1/2: apparent terminal half-life
PK profile of naproxen and indomethacin from plasma and urine
Time frame: Day 1, Day 6 (urine only), Day 7, Day 14
Profile in terms of AUC, Tmax, Cmax, and t1/2
1 secondary outcome
Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
Time frame: 13 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 8 Nov 2013.
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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.
S Bradley, MD 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 400 mg, naproxen 250 mg and indomethacin 25 mg in people with Gout, 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 3 inclusion and 6 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 8 Nov 2013. 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?
PK profile of lesinurad from plasma and urine (time frame: Day 1, Day 6 (urine only), Day 7, Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2013.