HealthyPhase 1NCT01908257
Lesinurad Interaction Study With Ranitidine
A Phase 1 study testing lesinurad 400 mg, ranitidine 150 mg and lesinurad 400 mg + ranitidine 150 mg in people with Healthy, 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 ranitidine on lesinurad. 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
- Healthy
- What is being tested?
- lesinurad 400 mg, ranitidine 150 mg and lesinurad 400 mg + ranitidine 150 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Nov 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
- body weight ≥ 50 kg (110 lbs) and body mass index ≥ 18 and ≤ 30 kg/m2.
- Screening sUA value ≤ 7.0 mg/dL.
- 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 abnormalties in vital signs, ECG, physical examination or safety laboratory values per the Investigator's judgment.
Who cannot join
- history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic renal,urological, or psychiatric disorders.
- history or suspicion of kidney stones.
- undergone major surgery within 3 months prior to Day 1.
- 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.
- 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, Open-Label, Drug-Drug Interaction Study to Evaluate the Potential Effects of Ranitidine on the Pharmacokinetics of Lesinurad in Healthy Adult Male Subjects
This is a drug-drug interaction study in healthy volunteers to evaluate the potential pharmacokinetic (PK) effects of ranitidine on lesinurad.
Read the detailed description
This study will evaluate the potential effect of ranitidine on the pharmacokinetics of lesinurad. An earlier study demonstrated an effect on lesinurad PK in the presence of both calcium-containing and magnesium- and aluminum-containing antacids. The current study will assess whether raising gastric pH, without the presence of these cations, affects lesinurad PK and PD under the fasted state. If an impact is seen, then the optional second cohort will be conducted under the fed state.
- Conditions
- Healthy
- Being tested
- lesinurad 400 mg, ranitidine 150 mg, lesinurad 400 mg + ranitidine 150 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lesinurad 400 mgDrug
ranitidine 150 mgDrug
lesinurad 400 mg + ranitidine 150 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 fasted | Experimental | Day 1: Lesinurad 400 mg once daily (qd)
Day 5: Ranitidine 150 mg twice daily (bid)
Day 6: Lesinurad 400 mg (qd) + ranitidine 150 mg (bid). Ranitidine dosed at -2 hours predose and 12 hours postdose of lesinurad.
Day 7: Ranitidine 150 mg (bid) Receives: Drug: lesinurad 400 mg; Drug: ranitidine 150 mg; Drug: lesinurad 400 mg + ranitidine 150 mg |
| Sequence 2 fasted | Experimental | Day 1: Ranitidine 150 mg (bid)
Day 2: Lesinurad 400 mg (qd) + ranitidine 150 mg (bid). Ranitidine dosed at -2 hours predose and 12 hours postdose of lesinurad
Day 3: Ranitidine 150 mg (bid)
Day 7: Lesinurad 400 mg (qd) Receives: Drug: lesinurad 400 mg; Drug: ranitidine 150 mg; Drug: lesinurad 400 mg + ranitidine 150 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 Cmax, Tmax, AUC, CL/F, t1/2
Cmax: maximum concentration; Tmax: time to reach max plasma concentration; AUC: area under the concentration-time curve; CL/F: total body clearance corrected for bioavailability; t1/2: apparent terminal half-life
Measured: Days 1 and 6 (Sequence 1) or Days 2 and 7 (Sequence 2)
Secondary outcomes (2)
Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
Measured: 6 weeks
PD profile of lesinurad from serum
Profile in terms of serum urate concentration
Measured: Days 1 and 6 (Sequence 1) or Days 2 and 7 (Sequence 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013
- Study completionNov 2013
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
- 16 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
- NCT01908257
- Sponsor's protocol ID
- RDEA594-127
- Status last verified
- Jan 2014
- First submitted
- 23 Jul 2013
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Potential Effects of Ranitidine on the Pharmacokinetics of Lesinurad in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT01908257
- Acronym / sponsor ID
- RDEA594-127
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ardea Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 Jul 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 ranitidine on lesinurad.
Detailed description
This study will evaluate the potential effect of ranitidine on the pharmacokinetics of lesinurad. An earlier study demonstrated an effect on lesinurad PK in the presence of both calcium-containing and magnesium- and aluminum-containing antacids. The current study will assess whether raising gastric pH, without the presence of these cations, affects lesinurad PK and PD under the fasted state. If an impact is seen, then the optional second cohort will be conducted under the fed state.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 fasted | Experimental | Drug: lesinurad 400 mg, Drug: ranitidine 150 mg, Drug: lesinurad 400 mg + ranitidine 150 mgDay 1: Lesinurad 400 mg once daily (qd) Day 5: Ranitidine 150 mg twice daily (bid) Day 6: Lesinurad 400 mg (qd) + ranitidine 150 mg (bid). Ranitidine dosed at -2 hours predose and 12 hours postdose of lesinurad. Day 7: Ranitidine 150 mg (bid) |
| Sequence 2 fasted | Experimental | Drug: lesinurad 400 mg, Drug: ranitidine 150 mg, Drug: lesinurad 400 mg + ranitidine 150 mgDay 1: Ranitidine 150 mg (bid) Day 2: Lesinurad 400 mg (qd) + ranitidine 150 mg (bid). Ranitidine dosed at -2 hours predose and 12 hours postdose of lesinurad Day 3: Ranitidine 150 mg (bid) Day 7: Lesinurad 400 mg (qd) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- body weight ≥ 50 kg (110 lbs) and body mass index ≥ 18 and ≤ 30 kg/m2.
- Screening sUA value ≤ 7.0 mg/dL.
- 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 abnormalties in vital signs, ECG, physical examination or safety laboratory values per the Investigator's judgment.
Key exclusion criteria (5 listed)
- history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic renal,urological, or psychiatric disorders.
- history or suspicion of kidney stones.
- undergone major surgery within 3 months prior to Day 1.
- 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.
- 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 | Drug | Sequence 1 fasted, Sequence 2 fasted |
| ranitidine 150 mg | Drug | Sequence 1 fasted, Sequence 2 fasted |
| lesinurad 400 mg + ranitidine 150 mg | Drug | Sequence 1 fasted, Sequence 2 fasted |
Primary outcome
PK profile of lesinurad from plasma and urine
Time frame: Days 1 and 6 (Sequence 1) or Days 2 and 7 (Sequence 2)
Profile in terms of Cmax, Tmax, AUC, CL/F, t1/2 Cmax: maximum concentration; Tmax: time to reach max plasma concentration; AUC: area under the concentration-time curve; CL/F: total body clearance corrected for bioavailability; t1/2: apparent terminal half-life
2 secondary outcomes
Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
Time frame: 6 weeks
PD profile of lesinurad from serum
Time frame: Days 1 and 6 (Sequence 1) or Days 2 and 7 (Sequence 2)
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 9 Jan 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.
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, ranitidine 150 mg and lesinurad 400 mg + ranitidine 150 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 4 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 9 Jan 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 and urine (time frame: Days 1 and 6 (Sequence 1) or Days 2 and 7 (Sequence 2)). 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 9 Jan 2014.