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

Part of paid clinical trials in Orlando, Florida.

Sponsor
AbbVie
Study ID
NCT04810598
Phase
PHASE1
Status
Completed

Conditions

  • Renal Disease
  • Renal Impairment

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

Study 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.

Key Dates

Start date
Jul 8, 2021
Status verified
Sep 2022
Primary completion
Aug 16, 2022
Completion
Aug 16, 2022

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group 1: Participants With Normal Renal Function
    Participants with normal renal function will receive single dose of venetoclax on Day 1.
  • Experimental: Group 2: Participants With End Stage Renal Disease
    Participants with end stage renal disease (ESRD) will receive single dose of venetoclax on Period 1 Day 1 and Period 2 Day 1 (Each period is 3 days separated by 7-day washout period).

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 38 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Orlando Clinical Research Ctr /ID# 224922OrlandoFlorida32809-
Acpru /Id# 243398GrayslakeIllinois60030-

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By research site
Orlando Clinical Research Ctr· Orlando, FLAcpru· Grayslake, IL

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