Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, Venetoclax, ABT-199, Venclexta, Venclyxto
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.
Interventions
DRUGVenetoclax
Oral Tablet
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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 \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AE) | Up to Approximately 18 Months | 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. |
| Maximum Observed Plasma Concentration (Cmax) of Venetoclax Hot Melt Extrusion-03 (HME-03) | Up to Approximately 18 Months | Cmax of venetoclax HME-03. |
| Time to Cmax (Tmax) of Venetoclax HME-03 | Up to Approximately 18 Months | Tmax of venetoclax HME-03. |
| Apparent Terminal Phase Elimination Constant (β) of Venetoclax HME-03 | Up to Approximately 18 Months | β of venetoclax HME-03. |
| Terminal Phase Elimination Half-Life (t1/2) of Venetoclax HME-03 | Up to Approximately 18 Months | t1/2 of venetoclax HME-03. |
| Area Under the Plasma Concentration-Time Curve from Time 0 Until the Last Measurable Concentration (AUCt) of Venetoclax HME-03 | Up to Approximately 18 Months | AUCt of venetoclax HME-03. |
| Area Under the Plasma Concentration-Time Curve from Time 0 Until Infinity (AUCinf) of Venetoclax HME-03 | Up to Approximately 18 Months | AUCinf of venetoclax HME-03. |
Countries
United States
Outcome results
None listed