Healthy VolunteersPhase 1NCT06070948
A Study to Assess Food Effect of Venetoclax New Tablet Formulation in Healthy Female Participants
A Phase 1 study testing Venetoclax in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Venetoclax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2023to 28 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Bioavailability and Food Effect Study of Venetoclax New High Drug Load Tablet Formulation in Healthy Female Subjects
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.
- Conditions
- Healthy Volunteers
- Being tested
- Venetoclax
- Keywords
- Venetoclax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Oral; Tablet
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Experimental | Participants will receive venetoclax dose A commercial formulation following a high-fat meal. Receives: Drug: Venetoclax |
| Regimen B | Experimental | Participants will receive venetoclax dose B new formulation following a high-fat meal. Receives: Drug: Venetoclax |
| Regimen C | Experimental | Participants will receive venetoclax dose A new formulation following a high-fat meal. Receives: Drug: Venetoclax |
| Regimen D | Experimental | Participants will receive venetoclax dose B new formulation under fasted conditions. Receives: Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Venetoclax
Cmax of Venetoclax will be assessed.
Measured: Up to Day 27
Time to Cmax (Tmax) of Venetoclax
Tmax of Venetoclax will be assessed.
Measured: Up to Day 27
Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Last Measurable Concentration (AUCt) of Venetoclax
AUCt of Venetoclax will be assessed.
Measured: Up to Day 27
AUC from Time 0 to Infinity (AUCinf) of Venetoclax
AUCinf of Venetoclax will be assessed.
Measured: Up to Day 27
Apparent Terminal Phase Elimination Rate Constant (β, BETA) of Venetoclax
Apparent terminal phase elimination rate constant (β, BETA) of Venetoclax will be assessed.
Measured: Up to Day 27
Terminal Phase Elimination Half-life (t1/2) of Venetoclax
Terminal phase elimination half-life (t1/2) of Venetoclax will be assessed.
Measured: Up to Day 27
Number of Adverse Events (AEs)
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.
Measured: Baseline to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start5 Oct 2023
- Primary completion28 Jul 2025 (estimated)
- Study completion28 Jul 2025 (estimated)
Why it stopped: Strategic considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070948
- Sponsor's protocol ID
- M22-457
- Status last verified
- Jun 2024
- First submitted
- 2 Oct 2023
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioavailability and Food Effect Study of Venetoclax New High Drug Load Tablet Formulation in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT06070948
- Acronym / sponsor ID
- M22-457
- Conditions
- Healthy Volunteers
- Keywords
- Venetoclax
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic considerations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 28 Jul 2025 (estimated)
- Study completion
- 28 Jul 2025 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Experimental | Drug: VenetoclaxParticipants will receive venetoclax dose A commercial formulation following a high-fat meal. |
| Regimen B | Experimental | Drug: VenetoclaxParticipants will receive venetoclax dose B new formulation following a high-fat meal. |
| Regimen C | Experimental | Drug: VenetoclaxParticipants will receive venetoclax dose A new formulation following a high-fat meal. |
| Regimen D | Experimental | Drug: VenetoclaxParticipants will receive venetoclax dose B new formulation under fasted conditions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenetoclaxOral; Tablet | Drug | Regimen A, Regimen B, Regimen C, Regimen D |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Venetoclax
Time frame: Up to Day 27
Cmax of Venetoclax will be assessed.
Time to Cmax (Tmax) of Venetoclax
Time frame: 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
Time frame: Up to Day 27
AUCt of Venetoclax will be assessed.
AUC from Time 0 to Infinity (AUCinf) of Venetoclax
Time frame: Up to Day 27
AUCinf of Venetoclax will be assessed.
Apparent Terminal Phase Elimination Rate Constant (β, BETA) of Venetoclax
Time frame: 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
Time frame: Up to Day 27
Terminal phase elimination half-life (t1/2) of Venetoclax will be assessed.
Number of Adverse Events (AEs)
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Venetoclax in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) of Venetoclax (time frame: Up to Day 27). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.