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BI 690517

Phase 1

Liver Diseases | Small molecule | Gastrointestinal |IQVIA Holdings, Inc.|Last Updated: Sep 20, 2024

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05731908A Study to Test How BI 690517 is Taken up in the Body of People With and Without Liver ProblemsPHASE1 COMPLETED 28Feb 21, 2023Apr 13, 2023Sep 20, 20242 United States
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Study Endpoints
Primary Endpoints
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Up to 4 days
Maximum measured concentration of the analyte in plasma (Cmax)
Up to 4 days
Secondary Endpoints
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Up to 4 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BI 690517 mild hepatic impairment (Child-Pugh A)EXPERIMENTAL -
BI 690517 normal hepatic functionEXPERIMENTALcontrol group
BI 690517 moderate hepatic impairment (Child-Pugh B)EXPERIMENTAL -
Interventions
NameTypeDescription
BI 690517DRUGBI 690517
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Male or female subjects aged at least 18 years at screening * Body mass index of 18.5 to 36.0 kg/m2 (inclusive) * Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. * Women of childbearing potential1 and ...

Countries:United States
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