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OpenTrials
Completed

NCT Number: NCT05909553

Study to Assess Adverse Events and Compare How Crushed, Ground, and Intact Oral Tablets Venetoclax Moves Through the Body of Healthy Female Adult Volunteers

The objective of this study is to assess the oral bioavailability of crushed and ground venetoclax commercial tablets relative to the intact venetoclax commercial tablets under fed condition in healthy female participants.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 255783

Grayslake, Illinois, 60030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must either 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.
  • 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).

Exclusion criteria

  • Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary or hepatic disease within the past 6 months that in the opinion 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.

Treatment and study plan

Venetoclax

Drug

Oral; Tablet

Other names: ABT-199, Venclaxta

Primary outcomes

  1. Number of Participants Experiencing Adverse Events

    Time frame: Up to 75 Days

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

  2. Maximum Observed Plasma Concentration (Cmax) of Venetoclax

    Time frame: Up to 45 Days

    Cmax of venetoclax.

  3. Time to Cmax (Tmax) of Venetoclax

    Time frame: Up to 45 Days

    Tmax of venetoclax.

  4. Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Venetoclax

    Time frame: Up to 45 Days

    AUCt of venetoclax.

  5. AUC From Time 0 to the Time Infinity (AUCinf) of Venetoclax

    Time frame: Up to 45 Days

    AUCinf of venetoclax.

  6. Apparent Terminal Phase Elimination Rate Constant (β) of Venetoclax

    Time frame: Up to 45 Days

    Apparent terminal phase elimination rate constant of venetoclax.

  7. Terminal Phase Elimination Half-life (t1/2) of Venetoclax

    Time frame: Up to 45 Days

    T1/2 of venetoclax.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1, Open-Label Study to Evaluate the Effect of Crushing and Grinding on the Bioavailability of Venetoclax Tablet in Healthy Adult Female Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2023
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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