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

Part of paid clinical trials in Grayslake, Illinois.

Sponsor
AbbVie
Study ID
NCT05909553
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 15, 2023
Status verified
Nov 2023
Primary completion
Sep 22, 2023
Completion
Sep 22, 2023

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax Sequence 1
    Participants will receive whole venetoclax, followed by crushed venetoclax, and completed with ground venetoclax for a 15 day period.
  • Experimental: Venetoclax Sequence 2
    Participants will receive crushed venetoclax, followed by ground venetoclax, and completed with whole venetoclax for a 15 day period.
  • Experimental: Venetoclax Sequence 3
    Participants will receive ground venetoclax, followed by whole venetoclax, and completed with crushed venetoclax for a 15 day period.

Primary Outcome Measure

Number of Participants Experiencing Adverse Events [ Time Frame: Up to 75 Days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Acpru /Id# 255783GrayslakeIllinois60030-

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Acpru· Grayslake, IL

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