Clareo Health | A Study to Learn About How BAY 3283142 Moves Into, Through, and Out of the Body After a Single Dose in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function
A Study to Learn About How BAY 3283142 Moves Into, Through, and Out of the Body After a Single Dose in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–79
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Participant must be 18 to 79 years (both inclusive) at the screening visit
Participants with hepatic impairment classified as Child-Pugh A or B
* Disease confirmed by histopathology, (e.g. previous liver biopsy), laparoscopy, CT, MRI, ultrasound or fibroscan
* Stable liver disease in the last 2 months
Participants who have normal hepatic function and are overtly healthy.
Body mass index (BMI): 18 to 36 kg/m\*2 (both inclusive).
Male or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Male participants: Must agree to use contraception/barrier as detailed below:
* Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
* Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person.
* Female participants: A female participant is eligible to participate if she is not pregnant or breast feeding, and one of the following conditions applies:
* Is a woman of nonchildbearing potential (WONCBP)
* Is a women of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate \< 1% per year), with low user dependency, starting from signing the informed consent form and for at least 10 days after the intake of study intervention. The investigator should evaluate the potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relationship to the dose of study intervention.
A WOCBP must have a negative highly sensitive pregnancy test within 24h before the first dose of study intervention.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
You may not be if
Severe ascites of more than 6 L (estimated by ultrasound)
Evidence of hepatic encephalopathy related to chronic liver disease \> grade 2 (exclusion by Number Connection Test).
Renal failure with an estimated glomerular filtration rate ≤40 mL/min (according to CKD-EPI equation).
Relevant diseases within the last 4 weeks prior to first study drug intervention.
Acute diarrhea or constipation within 14 days before the predicted first dosing day.
Febrile illness within 2 weeks prior to the admission of the study center
Tendency for vasovagal reactions (e.g. after venipuncture) or syncope.
