A Phase 1 interventional study of lesinurad/allopurinol 200/300 FDC tablets and lesinurad 200 mg in Gout, sponsored by Ardea Biosciences, Inc.. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-07.
Sponsored by Ardea Biosciences, Inc. (part of AstraZeneca) · Phase 1, Interventional, and Treatment
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Among 12 studies testing lesinurad in Gout — none open to participants now, none under way, none of them phase 3. lesinurad · Gout.
Among the 12 studies testing lesinurad in Gout, this one is the 11th largest by enrollment, is one of 2 that started in 2017, is one of 3 in phase 1, and was the 12th registered.
345 studies on the registry are indexed under Gout; 49 are open to participants now.
Browse Gout studies →None of the 12 studies testing lesinurad in Gout is open now. The open studies under Gout, anywhere →
lesinurad: first FDA approval 2015 (ZURAMPIC), first EMA approval 2016. What it is approved for, and how studies give it, is on its page →
Of the 30 Gout studies recruiting now, 14 (47%) set no upper age limit and 10 (33%) stop at 75 or younger; none take children under 18; none take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 32 is below the median of 83 across 286 interventional studies indexed under Gout.
Median enrollment 221 across the 12 interventional studies. Of the 12 that completed or were terminated, 7 (58%) have results posted.
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12 of 12 have an industry lead sponsor. The 2 most frequent:
This study is registered under Ardea Biosciences, Inc., one of the names counted as AstraZeneca. Under that name alone:
Ardea Biosciences, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.
27 studies in Gout by AstraZeneca: none open now, none under way, none of them phase 3. Of 26 finished, 14 (54%) have results posted.
Among the 27 studies in Gout by AstraZeneca, this one is the 19th largest by enrollment of the 24 interventional ones that give a count, is one of 2 that started in 2017, is one of 9 in phase 1, and was the 25th registered.
AstraZeneca’s Gout studies by the year they started, since 2008.
None of the studies under way reaches primary completion within a year.
Among the 12 studies testing lesinurad in Gout, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among AstraZeneca’s 27 in Gout:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
To assess the bioequivalence between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fasted state based on the pharmacokinetic (PK) evaluation of lesinurad and allopurinol in healthy adult subjects.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment A: Lesinurad/Allopurinol FDC Tablets - 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2).
Drug: lesinurad/allopurinol 200/300 FDC tablets · Drug: lesinurad 200 mg · Drug: allopurinol 300 mg
Treatment A: Lesinurad/Allopurinol FDC Tablets - 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2).
Drug: lesinurad/allopurinol 200/300 FDC tablets · Drug: lesinurad 200 mg · Drug: allopurinol 300 mg
Treatment A: Lesinurad/Allopurinol FDC Tablets - 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2).
Drug: lesinurad/allopurinol 200/300 FDC tablets · Drug: lesinurad 200 mg · Drug: allopurinol 300 mg
Treatment A: Lesinurad/Allopurinol FDC Tablets - 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2).
Drug: lesinurad/allopurinol 200/300 FDC tablets · Drug: lesinurad 200 mg · Drug: allopurinol 300 mg
Test Drug
Comparator 1
Comparator 2
Pharmacokinetics (PK) endpoints in terms of maximum observed concentration (Cmax) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets
Cmax is the maximum observed concentration of a drug after administration
Time frame: Days 1, 8, 15 and 22
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 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
Time frame: Days 1, 8, 15 and 22
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 FDC tablets relative to lesinurad and allopurinol monocomponent tablets
AUC 0-∞ is a meausre of total concentration from time zero to infinity
Time frame: Days 1, 8, 15 and 22
PK endpoints in terms of time of occurrence of maximum observed concentration (tmax) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets
Tmax is the time of occurrence of cmax
Time frame: Days 1, 8, 15 and 22
PK endpoints in terms of apparent terminal half-life (t1/2) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets
t1/2 is a measure of apparent terminal half-life
Time frame: Days 1, 8, 15 and 22
Incidence of Adverse Events in terms of changes in laboratory parameters
Time frame: 26 days
Incidence of Adverse Events in terms of electrocardiogram parameters
Time frame: 26 days
Incidence of Adverse Events in terms of vital signs
Time frame: 26 days
Incidence of Adverse Events in terms of physical examination findings
Time frame: 26 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2017 to primary completion in Oct 2017, 1 month.
Of 37 industry-sponsored phase 1 interventional studies under Gout, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 14. This study's 1 month is below that.
Counting every sponsor, half of 40 studies reached it within 6 months; a quarter within 1 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Lesinurad · Allopurinol