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)
72
1
4
4.8
15

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
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

  1. Maximum Observed Plasma Concentration (Cmax) of Venetoclax [Up to Day 27]

    Cmax of Venetoclax will be assessed.

  2. Time to Cmax (Tmax) of Venetoclax [Up to Day 27]

    Tmax of Venetoclax will be assessed.

  3. 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.

  4. AUC from Time 0 to Infinity (AUCinf) of Venetoclax [Up to Day 27]

    AUCinf of Venetoclax will be assessed.

  5. 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.

  6. 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.

  7. 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:

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:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by AbbVie
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2023