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

NCT05909553 | Completed Phase 1

• 1 other identifier: M24-301
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; Venetoclax; ABT-199

Outcome Measures

Primary Outcomes (7)

• Number of Participants Experiencing Adverse Events

  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.

  Up to 75 Days

• Maximum Observed Plasma Concentration (Cmax) of Venetoclax

  Cmax of venetoclax.

  Up to 45 Days

• Time to Cmax (Tmax) of Venetoclax

  Tmax of venetoclax.

  Up to 45 Days

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

  AUCt of venetoclax.

  Up to 45 Days

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

  AUCinf of venetoclax.

  Up to 45 Days

• Apparent Terminal Phase Elimination Rate Constant (β) of Venetoclax

  Apparent terminal phase elimination rate constant of venetoclax.

  Up to 45 Days

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

  T1/2 of venetoclax.

  Up to 45 Days

Study Arms (3)

Venetoclax Sequence 1

EXPERIMENTAL

Participants will receive whole venetoclax, followed by crushed venetoclax, and completed with ground venetoclax for a 15 day period.

Drug: Venetoclax

Venetoclax Sequence 2

EXPERIMENTAL

Participants will receive crushed venetoclax, followed by ground venetoclax, and completed with whole venetoclax for a 15 day period.

Drug: Venetoclax

Venetoclax Sequence 3

EXPERIMENTAL

Participants will receive ground venetoclax, followed by whole venetoclax, and completed with crushed venetoclax for a 15 day period.

Drug: Venetoclax

Interventions

Venetoclax DRUG

Oral; Tablet

Also known as: ABT-199, Venclaxta

Venetoclax Sequence 1; Venetoclax Sequence 2; Venetoclax Sequence 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 255783

Grayslake, Illinois, 60030, United States

Location

Related Publications (1)

• Alaei S, Wang Y, Liu Y, Schiele J, Deng R, Shiller D, Marroum P, Menon R, Salem AH. Venetoclax Clinical Pharmacokinetics After Administration of Crushed, Ground or Whole Tablets. Clin Ther. 2024 Oct;46(10):752-758. doi: 10.1016/j.clinthera.2024.03.012. Epub 2024 May 22.

  PMID: 38782609 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

venetoclax

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 18, 2023
• Study Start: June 15, 2023
• Primary Completion: September 22, 2023
• Study Completion: September 22, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)