HealthyPhase 1NCT02127775
Lesinurad Tablet Bioequivalence
A Phase 1 study testing Lesinurad 400 mg (manufactured at Site 1) and Lesinurad 400 mg (manufactured at Site 2) in people with Healthy, run by Ardea Biosciences, Inc. at 1 site in United States.
Trial summary
This study will assess the bioequivalence of lesinurad tablets manufactured at two different sites. 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 400 mg (manufactured at Site 1) and Lesinurad 400 mg (manufactured at Site 2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jul 2014
- 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
- Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
- Subject has a Screening serum urate level ≤ 7 mg/dL. ˗ Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.
Who cannot join
- Subject has any gastrointestinal disorder that affects motility and/or absorption.
- Subject has a history or suspicion of kidney stones.
- Subject has undergone major surgery within 3 months prior to Screening.
- 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, Randomized, Open-Label, Crossover Study to Assess the Bioequivalence of Lesinurad Tablets From Two Manufacturing Sites in Healthy Adult Male Subjects
This study will assess the bioequivalence of lesinurad tablets manufactured at two different sites.
Read the detailed description
This study is intended to evaluate the clinical comparability of lesinurad tablets manufactured at the 2 different sites by assessing relevant clinical Pharmacokinetics (PK) parameters.
- Conditions
- Healthy
- Being tested
- Lesinurad 400 mg (manufactured at Site 1), Lesinurad 400 mg (manufactured at Site 2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lesinurad 400 mg (manufactured at Site 1)Drug
Lesinurad 400 mg (manufactured at Site 2)Drug
| Study group | Role | What they receive |
|---|---|---|
| Sequence B | Experimental | Day 1: Lesinurad 400 mg (manufactured at Site 2); Day 5: Lesinurad 400 mg (manufactured at Site 1) Receives: Drug: Lesinurad 400 mg (manufactured at Site 1); Drug: Lesinurad 400 mg (manufactured at Site 2) |
| Sequence A | Experimental | Day 1: Lesinurad 400 mg (manufactured at Site 1); Day 5: Lesinurad 400 mg (manufactured at Site 2) Receives: Drug: Lesinurad 400 mg (manufactured at Site 1); Drug: Lesinurad 400 mg (manufactured at Site 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK profile of lesinurad from plasma
PK endpoints in terms of maximum observed concentration (Cmax); time of occurrence of maximum observed concentration (tmax); area under the plasma concentration time curve from zero to 24 hours post dose (AUC last) and from zero to infinity (AUC ∞); and apparent terminal half-life (t1/2). Point estimates and 90% confidence intervals for the ratio of geometric means for Cmax, AUC last and AUC∞ between test and reference formulations.
Measured: Day 1 and Day 5
Secondary outcomes (1)
Incidence of Adverse Events
Changes in Laboratory, Electrocardiogram and Vital Signs Parameters
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionJul 2014
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardea Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J. Hall, Study director, Ardea Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127775
- Sponsor's protocol ID
- RDEA594-132
- Status last verified
- Sep 2014
- First submitted
- 28 Apr 2014
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. 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 Bioequivalence of Lesinurad Tablets From Two Manufacturing Sites in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT02127775
- Acronym / sponsor ID
- RDEA594-132
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ardea Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 1 May 2014 (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 the bioequivalence of lesinurad tablets manufactured at two different sites.
Detailed description
This study is intended to evaluate the clinical comparability of lesinurad tablets manufactured at the 2 different sites by assessing relevant clinical Pharmacokinetics (PK) parameters.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence B | Experimental | Drug: Lesinurad 400 mg (manufactured at Site 1), Drug: Lesinurad 400 mg (manufactured at Site 2)Day 1: Lesinurad 400 mg (manufactured at Site 2); Day 5: Lesinurad 400 mg (manufactured at Site 1) |
| Sequence A | Experimental | Drug: Lesinurad 400 mg (manufactured at Site 1), Drug: Lesinurad 400 mg (manufactured at Site 2)Day 1: Lesinurad 400 mg (manufactured at Site 1); Day 5: Lesinurad 400 mg (manufactured at Site 2) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
- Subject has a Screening serum urate level ≤ 7 mg/dL. ˗ Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.
Key exclusion criteria (5 listed)
- Subject has any gastrointestinal disorder that affects motility and/or absorption.
- Subject has a history or suspicion of kidney stones.
- Subject has undergone major surgery within 3 months prior to Screening.
- 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.
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 (manufactured at Site 1) | Drug | Sequence A, Sequence B |
| Lesinurad 400 mg (manufactured at Site 2) | Drug | Sequence A, Sequence B |
Primary outcome
PK profile of lesinurad from plasma
Time frame: Day 1 and Day 5
PK endpoints in terms of maximum observed concentration (Cmax); time of occurrence of maximum observed concentration (tmax); area under the plasma concentration time curve from zero to 24 hours post dose (AUC last) and from zero to infinity (AUC ∞); and apparent terminal half-life (t1/2). Point estimates and 90% confidence intervals for the ratio of geometric means for Cmax, AUC last and AUC∞ between test and reference formulations.
1 secondary outcome
Incidence of Adverse Events
Time frame: 5 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 22 Sep 2014.
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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.
J. Hall 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 (manufactured at Site 1) and Lesinurad 400 mg (manufactured at Site 2) 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 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 22 Sep 2014. 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 (time frame: Day 1 and Day 5). 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 22 Sep 2014.