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

NCT04810598 | Completed Phase 1 FDA Drug

• 1 other identifier: M19-065
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Renal Impairment; Renal Disease

Keywords

Renal Impairment; Renal Disease; End stage renal disease (ESRD); Venetoclax; Venclexta

Outcome Measures

Primary Outcomes (8)

• Percentage of Participants With Adverse Events (AEs)

  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.

  Up to approximately 38 days

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

  Maximum Plasma Concentration (Cmax) of Venetoclax.

  Up to Day 6

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

  Time to Cmax (Tmax) of Venetoclax.

  Up to Day 6

• Area Under the Plasma Concentration-time Curve over time from time 0 to 48 hours (AUC0-48) of Venetoclax (Groups 1,2)

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

  Up to Day 6

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

  Unbound Fraction (fu) of Venetoclax in Plasma.

  Day 1

• Dialysis Clearance (CLdialysis) (Group 2)

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

  Day 1

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

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

  Day 1

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

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

  Day 1

Study Arms (2)

Group 1: Participants With Normal Renal Function

EXPERIMENTAL

Participants with normal renal function will receive single dose of venetoclax on Day 1.

Drug: Venetoclax

Group 2: Participants With End Stage Renal Disease

EXPERIMENTAL

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

Interventions

Venetoclax DRUG

Oral Tablet

Also known as: Venclexta, ABT-199, GDC-0199

Group 1: Participants With Normal Renal Function; Group 2: Participants With End Stage Renal Disease

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Participants on a strict vegetarian or vegan diet.

Sponsors & Collaborators

• AbbVie: lead
• Roche-Genentech: collaborator

Study Sites (2)

Orlando Clinical Research Ctr /ID# 224922

Orlando, Florida, 32809, United States

Location

Acpru /Id# 243398

Grayslake, Illinois, 60030, United States

Location

Related Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

MeSH Terms

Conditions

Renal Insufficiency; Kidney Diseases; Kidney Failure, Chronic

Interventions

venetoclax

Condition Hierarchy (Ancestors)

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

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: July 8, 2021
• Primary Completion: August 16, 2022
• Study Completion: August 16, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)