Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04810598
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : February 10, 2022
Sponsor:
Collaborator:
Roche-Genentech
Information provided by (Responsible Party):
AbbVie

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Renal Impairment Renal Disease Drug: Venetoclax Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of the Pharmacokinetics and Safety of Venetoclax in Subjects With Impaired Renal Function
Actual Study Start Date : July 8, 2021
Estimated Primary Completion Date : May 26, 2022
Estimated Study Completion Date : May 26, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Venetoclax

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Group 1: Participants With Normal Renal Function
Participants with normal renal function will receive single dose of venetoclax on Day 1.
 Drug: Venetoclax
Oral Tablet
Other Names:
  • Venclexta
  • ABT-199
  • GDC-0199
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).
 Drug: Venetoclax
Oral Tablet
Other Names:
  • Venclexta
  • ABT-199
  • GDC-0199


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04810598


Contacts
Layout table for location contacts
Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
Layout table for location information
United States, Florida
Orlando Clinical Research Ctr /ID# 224922 Recruiting
Orlando, Florida, United States, 32809
United States, Illinois
Acpru /Id# 243398 Recruiting
Grayslake, Illinois, United States, 60030
Sponsors and Collaborators
AbbVie
Roche-Genentech
Investigators
Layout table for investigator information
Study Director: ABBVIE INC. AbbVie
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04810598    
Other Study ID Numbers: M19-065
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AbbVie:
Renal Impairment
Renal Disease
End stage renal disease (ESRD)
Venetoclax
Venclexta
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency
Urologic Diseases
Venetoclax
Antineoplastic Agents