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

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06070948

Collaborator

(none)

Enrollment

Location

Arms

4.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Venetoclax	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 2, 2023

Anticipated Primary Completion Date :

Feb 25, 2024

Anticipated Study Completion Date :

Feb 25, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Regimen A Participants will receive venetoclax dose A commercial formulation following a high-fat meal.	Drug: Venetoclax Oral; Tablet
Experimental: Regimen B Participants will receive venetoclax dose B new formulation following a high-fat meal.	Drug: Venetoclax Oral; Tablet
Experimental: Regimen C Participants will receive venetoclax dose A new formulation following a high-fat meal.	Drug: Venetoclax Oral; Tablet
Experimental: Regimen D Participants will receive venetoclax dose B new formulation under fasted conditions.	Drug: Venetoclax Oral; Tablet

Outcome Measures

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of Venetoclax [Up to Day 27]
Cmax of Venetoclax will be assessed.
Time to Cmax (Tmax) of Venetoclax [Up to Day 27]
Tmax of Venetoclax will be assessed.
Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Last Measurable Concentration (AUCt) of Venetoclax [Up to Day 27]
AUCt of Venetoclax will be assessed.
AUC from Time 0 to Infinity (AUCinf) of Venetoclax [Up to Day 27]
AUCinf of Venetoclax will be assessed.
Apparent Terminal Phase Elimination Rate Constant (β, BETA) of Venetoclax [Up to Day 27]
Apparent terminal phase elimination rate constant (β, BETA) of Venetoclax will be assessed.
Terminal Phase Elimination Half-life (t1/2) of Venetoclax [Up to Day 27]
Terminal phase elimination half-life (t1/2) of Venetoclax will be assessed.
Number of Adverse Events (AEs) [Baseline to Day 57]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Acpru /Id# 259897	Grayslake	Illinois	United States	60030

Sponsors and Collaborators

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

AbbVie

ClinicalTrials.gov Identifier:

NCT06070948

Other Study ID Numbers:

M22-457

First Posted:

Oct 6, 2023

Last Update Posted:

Oct 6, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by AbbVie

Venetoclax

Additional relevant MeSH terms:

Venetoclax

Study Results

No Results Posted as of Oct 6, 2023