Clinical trial NCT04810598: 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
Official title: Evaluation of the Pharmacokinetics and Safety of Venetoclax in Subjects With Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Renal Disease
Keywords: Renal Impairment
Renal Disease
End stage renal disease (ESRD)
Venetoclax
Venclexta
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Roche-Genentech
First posted: 2021-03-23
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 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.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 18.0 and 42.0 kg/m2.
* Postmenopausal or permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
* Women of childbearing potential, practicing at least 2 protocol specified methods of birth control that are effective from at least 30 days before starting study drug through at least 30 days after the last dose of any study drug.
* Group 1 only: Must be in general good health based upon the results of a medical history, physical examination, and 12-lead electrocardiogram (ECG) with normal Glomerular Filtration Rate (GFR) at Screening.
* Group 2 only: Stable condition and acceptable for study participation based upon the results of a medical history, physical examination, laboratory profile, and ECG. Participant with end stage renal disease (ESRD) requiring dialysis on hemodialysis must have been receiving hemodialysis for at least 1 month.

Exclusion Criteria:

- Participants on a strict vegetarian or vegan diet.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to approximately 38 days
measure: Maximum Plasma Concentration (Cmax) of Venetoclax (Groups 1,2)
timeFrame: Up to Day 6
measure: Time to Cmax (Tmax) of Venetoclax (Groups 1,2)
timeFrame: Up to Day 6
measure: Area Under the Plasma Concentration-time Curve over time from time 0 to 48 hours (AUC0-48) of Venetoclax (Groups 1,2)
timeFrame: Up to Day 6
measure: Pre-dose Unbound Fraction (fu) of Venetoclax in Plasma (Groups 1,2)
timeFrame: Day 1
measure: Dialysis Clearance (CLdialysis) (Group 2)
timeFrame: Day 1
measure: Unbound Fraction Pre-dialysis (fu,predialysis) of Venetoclax in Plasma (Group 2)
timeFrame: Day 1
measure: Unbound Fraction Post-dialysis (fu,postdialysis) of Venetoclax in Plasma (Group 2)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Ctr /ID# 224922
state: Florida
city: Grayslake
country: United States
facility: Acpru /Id# 243398
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: