Clinical trial NCT06742086: A Study to Evaluate the Bioavailability and Food Effects of Oral Venetoclax New Tablet Formulation 2.0 in Healthy Adult Female Participants
Official title: A Bioavailability and Food Effect Study of Venetoclax New Tablet Formulation 2.0 in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
Venetoclax
ABT-199
Venclexta
Venclyxto
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-12-19
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the bioavailability (BA) of venetoclax new high drug load hot melt extrusion-03 (HME-03) tablet formulation at two different tablet strengths relative to the commercial venetoclax tablet formulation under high-fat conditions in healthy female volunteers. Additionally, this study will assess the potential food effect on the BA of the venetoclax HME-03 tablet at the highest dosage strength.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) is 18.0 to 32.0 kg/m\^2.
* Must either be: postmenopausal, permanently surgically sterile, or perimenopausal or premenopausal and practicing a method of birth control until at least 30 days after the last dose of study drug.
* Have CD19+ B-cell count \> 150 cells/μL at screening.

Exclusion Criteria:

* History: of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary, or hepatic diseases within the past 6 months that in the option of the investigator would adversely affect her participating in this study.
* History of any clinically significant sensitivity or allergy to any medication or food.
* History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].

Primary outcomes:
measure: Number of Participants with Adverse Events (AE)
timeFrame: Up to Approximately 18 Months
measure: Maximum Observed Plasma Concentration (Cmax) of Venetoclax Hot Melt Extrusion-03 (HME-03)
timeFrame: Up to Approximately 18 Months
measure: Time to Cmax (Tmax) of Venetoclax HME-03
timeFrame: Up to Approximately 18 Months
measure: Apparent Terminal Phase Elimination Constant (β) of Venetoclax HME-03
timeFrame: Up to Approximately 18 Months
measure: Terminal Phase Elimination Half-Life (t1/2) of Venetoclax HME-03
timeFrame: Up to Approximately 18 Months
measure: Area Under the Plasma Concentration-Time Curve from Time 0 Until the Last Measurable Concentration (AUCt) of Venetoclax HME-03
timeFrame: Up to Approximately 18 Months
measure: Area Under the Plasma Concentration-Time Curve from Time 0 Until Infinity (AUCinf) of Venetoclax HME-03
timeFrame: Up to Approximately 18 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 272979
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: