A Study to Assess Food Effect of Venetoclax New Tablet Formulation in Healthy Female Participants

NCT06070948 | Withdrawn Phase 1

• 1 other identifier: M22-457
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the bioavailability of two different doses of venetoclax new high drug load formulation tablets relative to two tablets of the currently marketed venetoclax tablets under fed conditions.

Conditions

Healthy Volunteers

Keywords

Venetoclax

Outcome Measures

Primary Outcomes (7)

• Maximum Observed Plasma Concentration (Cmax) of Venetoclax

  Cmax of Venetoclax will be assessed.

  Up to Day 27

• Time to Cmax (Tmax) of Venetoclax

  Tmax of Venetoclax will be assessed.

  Up to Day 27

• Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Last Measurable Concentration (AUCt) of Venetoclax

  AUCt of Venetoclax will be assessed.

  Up to Day 27

• AUC from Time 0 to Infinity (AUCinf) of Venetoclax

  AUCinf of Venetoclax will be assessed.

  Up to Day 27

• Apparent Terminal Phase Elimination Rate Constant (β, BETA) of Venetoclax

  Apparent terminal phase elimination rate constant (β, BETA) of Venetoclax will be assessed.

  Up to Day 27

• Terminal Phase Elimination Half-life (t1/2) of Venetoclax

  Terminal phase elimination half-life (t1/2) of Venetoclax will be assessed.

  Up to Day 27

• Number of 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.

  Baseline to Day 57

Study Arms (4)

Regimen A

EXPERIMENTAL

Participants will receive venetoclax dose A commercial formulation following a high-fat meal.

Drug: Venetoclax

Regimen B

EXPERIMENTAL

Participants will receive venetoclax dose B new formulation following a high-fat meal.

Drug: Venetoclax

Regimen C

EXPERIMENTAL

Participants will receive venetoclax dose A new formulation following a high-fat meal.

Drug: Venetoclax

Regimen D

EXPERIMENTAL

Participants will receive venetoclax dose B new formulation under fasted conditions.

Drug: Venetoclax

Interventions

Venetoclax DRUG

Oral; Tablet

Regimen A; Regimen B; Regimen C; Regimen D

Eligibility Criteria

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

You may qualify if:

• Body Mass Index (BMI) is \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal.
• A condition of general good health based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
• Participant must be postmenopausal, permanently surgically sterile, or perimenopausal or premenopausal and practicing a method of birth control until at least 1 month after the last dose of study drug.

You may not qualify if:

• \- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 259897

Grayslake, Illinois, 60030, United States

Location

Related Links

• Related Info

MeSH Terms

Interventions

venetoclax

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 6, 2023
• Study Start: October 5, 2023
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)