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BI 690517

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

BI 690517 · 1 trial · 2 indications

Phase 1 1
NCT05731908A Study to Test How BI 690517 is Taken up in the Body of People With and Without Liver ProblemsLiver Diseases
COMPLETED28 Analytics
PHASE1COMPLETED
A Study to Test How BI 690517 is Taken up in the Body of People With and Without Liver Problems
Liver DiseasesUnlock trial analytics

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 to 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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Frequently asked questions about BI 690517

What is BI 690517 used for?

BI 690517 is an investigational small molecule being studied for use in liver diseases. It is currently in Phase 1 clinical development, with a completed study evaluating how the drug is taken up in the body of people with and without liver problems.

Who makes BI 690517?

BI 690517 is being developed by IQVIA Holdings, Inc., a company traded on the stock exchange under the ticker symbol IQV. The drug is in Phase 1 clinical development for liver diseases.

What phase is BI 690517 in?

BI 690517 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials.

What clinical trials is BI 690517 in?

BI 690517 has one completed clinical trial, identified as NCT05731908, titled "A Study to Test How BI 690517 is Taken up in the Body of People With and Without Liver Problems." This Phase 1 study enrolled 28 participants in the United States.

Is BI 690517 being studied in healthy volunteers?

Yes, BI 690517 is being studied in healthy volunteers. The completed Phase 1 trial, NCT05731908, included healthy participants as well as those with liver problems, with a minimum age of 18 years.