Healthy Volunteers Clinical Trial
Official title:
A Bioavailability and Food Effect Study of Venetoclax New High Drug Load Tablet Formulation in Healthy Female Subjects
Verified date | June 2024 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 28, 2025 |
Est. primary completion date | July 28, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Acpru /Id# 259897 | Grayslake | Illinois |
Lead Sponsor | Collaborator |
---|---|
AbbVie |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Observed Plasma Concentration (Cmax) of Venetoclax | Cmax of Venetoclax will be assessed. | Up to Day 27 | |
Primary | Time to Cmax (Tmax) of Venetoclax | Tmax of Venetoclax will be assessed. | Up to Day 27 | |
Primary | 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 | |
Primary | AUC from Time 0 to Infinity (AUCinf) of Venetoclax | AUCinf of Venetoclax will be assessed. | Up to Day 27 | |
Primary | Apparent Terminal Phase Elimination Rate Constant (ß, BETA) of Venetoclax | Apparent terminal phase elimination rate constant (ß, BETA) of Venetoclax will be assessed. | Up to Day 27 | |
Primary | 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 | |
Primary | 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 |
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