Renal insufficiency is common in participants with blood cancers. The main objective of this study is to evaluate adverse events and movement of oral venetoclax tablets through the body of female participants with severe normal renal function and those with end stage renal disease (ESRD) requiring hemodialy...
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Location | Status | Site Contact Details |
---|---|---|
Location Orlando Clinical Research Ctr, Orlando, Florida, 32809 | Status Not Available | Site Contact Details |
Location Acpru, Grayslake, Illinois, 60030 | Status Not Available | Site Contact Details |
Renal insufficiency is common in participants with blood cancers. The main objective of this study is to evaluate adverse events and movement of oral venetoclax tablets through the body of female participants with severe normal renal function and those with end stage renal disease (ESRD) requiring hemodialysis. Venetoclax is an investigational drug being developed for the treatment of various hematologic malignancies. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. Approximately 12 female participants between 18 and 75 years, with Body Mass Index (BMI) between 18 to 42 kg/m2 will be enrolled in approximately 4 sites across the world. Participants with normal renal function will receive single dose of oral venetoclax tablet. Participants with ESRD will receive oral venetoclax tablets just prior to hemodialysis (Period 1 Day 1) and between dialysis days (Period 2 Day 1), doses in the two periods will be separated by at least 7 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and urine tests, checking for side effects.
Percentage of Participants With Adverse Events (AEs)
Time Frame: Up to approximately 38 days
Maximum Plasma Concentration (Cmax) of Venetoclax (Groups 1,2)
Time Frame: Up to Day 6
Time to Cmax (Tmax) of Venetoclax (Groups 1,2)
Time Frame: Up to Day 6
Area Under the Plasma Concentration-time Curve over time from time 0 to 48 hours (AUC0-48) of Venetoclax (Groups 1,2)
Time Frame: Up to Day 6
Pre-dose Unbound Fraction (fu) of Venetoclax in Plasma (Groups 1,2)
Time Frame: Day 1
Dialysis Clearance (CLdialysis) (Group 2)
Time Frame: Day 1
Unbound Fraction Pre-dialysis (fu,predialysis) of Venetoclax in Plasma (Group 2)
Time Frame: Day 1
Unbound Fraction Post-dialysis (fu,postdialysis) of Venetoclax in Plasma (Group 2)
Time Frame: Day 1
Interventions:
Enrollment:
12
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