A Study to Evaluate the Bioavailability and Food Effects of Oral Venetoclax New Tablet Formulation 2.0 in Healthy Adult Female Participants

Part of paid clinical trials in Grayslake, Illinois.

Sponsor
AbbVie
Study ID
NCT06742086
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The objective of this study is to assess the bioavailability (BA) of venetoclax new high drug load hot melt extrusion-03 (HME-03) tablet formulation at two different tablet strengths relative to the commercial venetoclax tablet formulation under high-fat conditions in healthy female volunteers. Additionally, this study will assess the potential food effect on the BA of the venetoclax HME-03 tablet at the highest dosage strength.

Key Dates

Start date
Dec 19, 2024
Status verified
Aug 2025
Primary completion
Oct 8, 2025
Completion
Oct 8, 2025

Study Design

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

Arms

  • Experimental: Stage 1: Sequence 1: Venetoclax
    Participants will receive commercial venetoclax following a high-fat meal (Regimen A), followed by venetoclax hot melt extrusion-03 (HME-03) dose A following a high-fat meal (Regimen B), followed by venetoclax HME-03 dose B following a high-fat meal (Regimen C), finally followed by venetoclax HME-03 dose A following fasting (Regimen D), as part of the approximately 18 month study duration.
  • Experimental: Stage 1: Sequence 2: Venetoclax
    Participants will receive Regimen B, followed by Regimen C, followed by Regimen A, finally followed by Regimen D, as part of the approximately 18 month study duration.
  • Experimental: Stage 1: Sequence 3: Venetoclax
    Participants will receive Regimen C, followed by Regimen A, followed by Regimen B, finally followed by Regimen D, as part of the approximately 18 month study duration.
  • Experimental: Stage 2: Sequence 1: Venetoclax
    Participants will receive Regimen A, followed by Regimen B, finally followed by Regimen C, as part of the approximately 18 month study duration.
  • Experimental: Stage 2: Sequence 2: Venetoclax
    Participants will receive Regimen B, followed by Regimen C, finally followed by Regimen A, as part of the approximately 18 month study duration.
  • Experimental: Stage 2: Sequence 3: Venetoclax
    Participants will receive Regimen C, followed by Regimen A, finally followed by Regimen B, as part of the approximately 18 month study duration.

Primary Outcome Measure

Number of Participants with Adverse Events (AE) [ Time Frame: Up to Approximately 18 Months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Acpru /Id# 272979GrayslakeIllinois60030-
PPD Phase I Clinic /ID# 275754AustinTexas78744-

Find similar trials in Grayslake, IL

By research site
Acpru· Grayslake, ILPPD Phase I Clinic· Austin, TX

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