Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810598
Status:
COMPLETED
Last Update Posted:
2022-09-16
First Post:
2021-03-19
Brief Title:
Study to Assess Adverse Events and the Movement of Oral Venetoclax Tablet Through the Body of Female Participants Aged 18-75 Years With Impaired Renal Function
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
Evaluation of the Pharmacokinetics and Safety of Venetoclax in Subjects With Impaired Renal Function
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 kgm2 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
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 kgm2 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None