A Study to Assess Food Effect of Venetoclax New Tablet Formulation in Healthy Female Participants
- Registration Number
- NCT06070948
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Regimen B Venetoclax Participants will receive venetoclax dose B new formulation following a high-fat meal. Regimen A Venetoclax Participants will receive venetoclax dose A commercial formulation following a high-fat meal. Regimen C Venetoclax Participants will receive venetoclax dose A new formulation following a high-fat meal. Regimen D Venetoclax Participants will receive venetoclax dose B new formulation under fasted conditions.
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of Venetoclax Up to Day 27 Cmax of Venetoclax will be assessed.
Apparent Terminal Phase Elimination Rate Constant (β, BETA) of Venetoclax Up to Day 27 Apparent terminal phase elimination rate constant (β, BETA) of Venetoclax will be assessed.
Time to Cmax (Tmax) of Venetoclax Up to Day 27 Tmax of Venetoclax will be assessed.
Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Last Measurable Concentration (AUCt) of Venetoclax Up to Day 27 AUCt of Venetoclax will be assessed.
AUC from Time 0 to Infinity (AUCinf) of Venetoclax Up to Day 27 AUCinf of Venetoclax will be assessed.
Terminal Phase Elimination Half-life (t1/2) of Venetoclax Up to Day 27 Terminal phase elimination half-life (t1/2) of Venetoclax will be assessed.
Number of Adverse Events (AEs) Baseline to Day 57 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Acpru /Id# 259897
🇺🇸Grayslake, Illinois, United States