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

NCT ID: NCT05909553

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2023-09-22

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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Healthy Volunteers Venetoclax ABT-199

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Venetoclax Sequence 1

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

Group Type EXPERIMENTAL

Venetoclax

Intervention Type DRUG

Oral; Tablet

Venetoclax Sequence 2

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

Group Type EXPERIMENTAL

Venetoclax

Intervention Type DRUG

Oral; Tablet

Venetoclax Sequence 3

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

Group Type EXPERIMENTAL

Venetoclax

Intervention Type DRUG

Oral; Tablet

Interventions

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Venetoclax

Oral; Tablet

Intervention Type DRUG

Other Intervention Names

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ABT-199 Venclaxta

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Acpru /Id# 255783

Grayslake, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38782609 (View on PubMed)

Related Links

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https://www.abbvieclinicaltrials.com/study/?id=M24-301

Related Info

Other Identifiers

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M24-301

Identifier Type: -

Identifier Source: org_study_id