Status:
COMPLETED
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
Lead Sponsor:
AbbVie
Collaborating Sponsors:
Roche-Genentech
Conditions:
Renal Impairment
Renal Disease
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
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 part...
Eligibility Criteria
Inclusion
- 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
- \- Participants on a strict vegetarian or vegan diet.
Key Trial Info
Start Date :
July 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04810598
Start Date
July 8 2021
End Date
August 16 2022
Last Update
September 16 2022
Active Locations (2)
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1
Orlando Clinical Research Ctr /ID# 224922
Orlando, Florida, United States, 32809
2
Acpru /Id# 243398
Grayslake, Illinois, United States, 60030