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NCT Number: 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

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.

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Key information

Conditions

Renal Impairment Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Disease Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Orlando Clinical Research Ctr /ID# 224922, Orlando, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Venetoclax

Drug

Oral Tablet

Other names: Venclexta, ABT-199, GDC-0199

Primary outcomes

  1. Percentage of Participants With Adverse Events (AEs)

    Time frame: Up to approximately 38 days

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

  2. Maximum Plasma Concentration (Cmax) of Venetoclax (Groups 1,2)

    Time frame: Up to Day 6

    Maximum Plasma Concentration (Cmax) of Venetoclax.

  3. Time to Cmax (Tmax) of Venetoclax (Groups 1,2)

    Time frame: Up to Day 6

    Time to Cmax (Tmax) of Venetoclax.

  4. 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

    Area Under the Plasma Concentration-time Curve over time from time 0 to 48 hours (AUC0-48).

  5. Pre-dose Unbound Fraction (fu) of Venetoclax in Plasma (Groups 1,2)

    Time frame: Day 1

    Unbound Fraction (fu) of Venetoclax in Plasma.

  6. Dialysis Clearance (CLdialysis) (Group 2)

    Time frame: Day 1

    Dialysis Clearance (CLdialysis) is calculated in participants undergoing hemodialysis in Period 1.

  7. Unbound Fraction Pre-dialysis (fu,predialysis) of Venetoclax in Plasma (Group 2)

    Time frame: Day 1

    Unbound fraction pre-dialysis (fu,predialysis) of venetoclax in plasma is calculated in participants undergoing hemodialysis in Period 1.

  8. Unbound Fraction Post-dialysis (fu,postdialysis) of Venetoclax in Plasma (Group 2)

    Time frame: Day 1

    Unbound fraction post-dialysis (fu,postdialysis) of venetoclax in plasma is calculated in participants undergoing hemodialysis in Period 1.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Collaborators

  • Roche-Genentech

Registry information

Official study title

Evaluation of the Pharmacokinetics and Safety of Venetoclax in Subjects With Impaired Renal Function

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 23, 2021
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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