Recent Updates
Recently added Catalysts

dontinurad

Phase 1

Gout | Small molecule | Metabolic |Fortress Biotech, Inc.|Last Updated: Jan 28, 2025

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical trial landscape

dontinurad · 1 trial · 2 indications

Phase 1 1
NCT06056570Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients with HyperuricemiaGout
COMPLETED20 Analytics
PHASE1COMPLETED
Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients with Hyperuricemia
GoutUnlock trial analytics
Study Endpoints
Primary Endpoints
Peak plasma concentrations (Cmax)
7 days

To evaluate the Cmax of dotinurad 2mg, dotinturad 4mg, and allopurinol 300mg

Area under the plasma concentration versus time curve (AUC)
7 days

To evaluate the AUC of dotinurad 2mg, dotinturad 4mg, and allopurinol 300mg

Time to maximum plasma concentration (Tmax)
7 days

To evaluate the Tmax of dotinurad 2mg, dotinturad 4mg, and allopurinol 300mg

Terminal half life (T1/2)
7 days

To evaluate the T1/2 of dotinurad 2mg, dotinturad 4mg, and allopurinol 300mg

Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
dotinurad 2mgEXPERIMENTALdotinurad 2mg q.d.
dotinurad 4mgEXPERIMENTALdotinurad 4mg q.d.
Interventions
NameTypeDescription
dontinuradDRUGdotinurad alone
dotinurad + allopurinolDRUGdotinurad + allopurinol 300mg
allopurinolDRUGallopurinol 300 mg alone
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * 1\. In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements. 2\. Patients with a diagnosis of gout based on American College of Rheumatology criteria (1997). Patients must fulfill at least 3 of the following, with...

Countries:United States
Unlock Eligibility Criteria