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

Part of paid clinical trials in Grayslake, Illinois.

Sponsor
AbbVie
Study ID
NCT06070948
Phase
PHASE1
Status
Withdrawn

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 5, 2023
Status verified
Jun 2024
Primary completion
Jul 28, 2025
Completion
Jul 28, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen A
    Participants will receive venetoclax dose A commercial formulation following a high-fat meal.
  • Experimental: Regimen B
    Participants will receive venetoclax dose B new formulation following a high-fat meal.
  • Experimental: Regimen C
    Participants will receive venetoclax dose A new formulation following a high-fat meal.
  • Experimental: Regimen D
    Participants will receive venetoclax dose B new formulation under fasted conditions.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Venetoclax [ Time Frame: Up to Day 27 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Acpru /Id# 259897GrayslakeIllinois60030-

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Acpru· Grayslake, IL

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