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Official title A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems
ClinicalTrials.gov ID: NCT07023354
What this study is testing
What is BI 1291583?
BI 1291583 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy.
Also referred to as Verducatib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 18.5 to 42 kg/m². People with or without liver problems can take part in the study.
- Phase 1: an early, usually small safety study
- Time commitment: about 3 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Male or female trial participants aged ≥18 and ≤80 years at screening
- Body Mass Index (BMI) of 18.5 to 42 kg/m² (inclusive)
- Signed and dated written informed consent in accordance with International Council on Harmonisation (ICH) Harmonized Guideline for Good Clinical...
- Female trial participants who meet any of the following criteria for a highly effective contraception from at least 30 days before the first...
- Use of combined (oestrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus condom
You likely can't join if
- Exclusion criteria applying to all trial participants:
- Any medical condition or finding in the medical examination that in the investigator's opinion assessed as clinically relevant, poses a safety risk...
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance (apart from values due to underlying...
- Severe gastrointestinal, renal (estimated Glomerular Filtration Rate (eGFR) Chronic Kidney Disease Epidemiology (CKD-EPI) \<40 ml/min/1.73 m2 for the...
- Alpha fetoprotein \>50 ng/mL (\>50 µg/L) at screening
- Surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except cholecystectomy, appendectomy or...
See the full eligibility criteria
- Male or female trial participants aged ≥18 and ≤80 years at screening
- Body Mass Index (BMI) of 18.5 to 42 kg/m² (inclusive)
- Signed and dated written informed consent in accordance with International Council on Harmonisation (ICH) Harmonized Guideline for Good Clinical Practice (GCP) and local legislation prior to admission to the trial
- Female trial participants who meet any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 5 months after trial dosing
- Use of combined (oestrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus condom
- Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom
- Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) plus use of condom
- Sexually abstinent
- A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant
- Surgically sterilised (including hysterectomy) plus use of condom
- Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle Stimulating Hormone (FSH) above 25 U/L and oestradiol below 30 ng/L is...
- Hepatic impairment classified as Child-Pugh A (score 5-6 points) or Child-Pugh B (score 7-9 points) or Child Pugh C (score 10-15 points)
- Absence of significant abnormalities, as based on a complete medical history including a full physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical...
- Medication and/or treatment regimens must have been stable (i. e., no dose adjustments) for at least 7 days or 5 half-lives (whichever is longer) prior to the planned randomisation and should be kept stable until study...
- Exclusion criteria applying to all trial participants:
- Any medical condition or finding in the medical examination that in the investigator's opinion assessed as clinically relevant, poses a safety risk for the trial participant or may interfere with the study objectives...
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance (apart from values due to underlying disease)
- Severe gastrointestinal, renal (estimated Glomerular Filtration Rate (eGFR) Chronic Kidney Disease Epidemiology (CKD-EPI) \<40 ml/min/1.73 m2 for the hepatic impaired trial participants and Estimated Glomerular...
- Alpha fetoprotein \>50 ng/mL (\>50 µg/L) at screening
- Surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except cholecystectomy, appendectomy or simple hernia repair)
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Relevant chronic or acute infections
- Further exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Orlando, Florida, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orlando, Florida, United States; Houston, Texas, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.