A Study to Assess Food Effect of Venetoclax New Tablet Formulation in Healthy Female Participants

Healthy Volunteers Clinical Trial

Official title:

A Bioavailability and Food Effect Study of Venetoclax New High Drug Load Tablet Formulation in Healthy Female Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06070948
• Other study ID #: M22-457
• Status: Withdrawn
• Phase: Phase 1
• Start date: October 5, 2023
• Est. completion date: July 28, 2025

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Venetoclax
Oral; Tablet

Locations

Country	Name	City	State
United States	Acpru /Id# 259897	Grayslake	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

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