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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT06070948
Other study ID # M22-457
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


Related Conditions & MeSH terms


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
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