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Colchicine

Phase 1

Gout | Small molecule | Musculoskeletal |Co-Diagnostics, Inc.|Last Updated: Aug 8, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03131583The Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With GoutPHASE1 COMPLETED 15Feb 17, 2017Jan 29, 2018Aug 8, 20191 China
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Study Endpoints
Primary Endpoints
Maximun observed concentration (Cmax) of Febuxostat and Colchicine from plasma
Clinical significant changes from baseline up to Day 8

PK profile

Area under the concentration-time curve (AUC) of Febuxostat and Colchicine from plasma
Clinical significant changes from baseline up to Day 8

PK profile

Apparent terminal half-life (t1/2) of Febuxostat and Colchicine from plasma
Clinical significant changes from baseline up to Day 8

PK profile

Secondary Endpoints
Incidence of Adverse events
Clinical significant changes from Day-14 up to Day 16
Changes in Laboratory Values
Clinical significant changes from Day-14 up to Day 16
Changes in Electrocardiogram
Clinical significant changes from Day-14 up to Day 16
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALColchicine 0.5 mg Oral Tablet Day-14\~Day16 qd, Febuxostat 80 mg Oral Tablet Day1 and Day8 qd, SHR4640 10 mg Oral Tablet Day3\~Day8 qd.
Interventions
NameTypeDescription
ColchicineDRUGDay-14\~Day16 qd
FebuxostatDRUGDay1 and Day8 qd
SHR4640DRUGDay3\~Day8 qd
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Subject has a body mass index ≥18.5 and ≤30 kg/m2; 2. Screening sUA value ≥8mg/dl; 3. Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination,imaging examination or safety laboratory values. Exclusion Criteria: 1. Subject known or suspecte...

Countries:China
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Competitive Landscape -Gout 5 trials