A Study to Evaluate the Bioavailability and Food Effects of Oral Venetoclax New Tablet Formulation 2.0 in Healthy Adult Female Participants

Phase 1CompletedNCT06742086

AbbVie72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteer

Interventions

VenetoclaxDRUG

Oral Tablet

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].

Locations (2)

Acpru /Id# 272979

Grayslake, Illinois, United States

PPD Phase I Clinic /ID# 275754

Austin, Texas, United States

Outcomes

Primary Outcomes

Number of Participants with Adverse Events (AE)

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.