Healthy VolunteersPhase 1NCT05909553
Study to Assess Adverse Events and Compare How Crushed, Ground, and Intact Oral Tablets Venetoclax Moves Through the Body of Healthy Female Adult Volunteers
A Phase 1 study testing Venetoclax in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
Trial summary
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. 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
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2023to 22 Sep 2023
- 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
- Must either 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.
- 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).
Who cannot join
- Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary or hepatic disease within the past 6 months that in the opinion of the investigator would adversely affect her participating in this study.
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study to Evaluate the Effect of Crushing and Grinding on the Bioavailability of Venetoclax Tablet in Healthy Adult Female Subjects
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.
- Conditions
- Healthy Volunteers
- Being tested
- Venetoclax
- Keywords
- Healthy Volunteers, Venetoclax, ABT-199
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Also called ABT-199, Venclaxta
Oral; Tablet
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax Sequence 1 | Experimental | Participants will receive whole venetoclax, followed by crushed venetoclax, and completed with ground venetoclax for a 15 day period. Receives: Drug: Venetoclax |
| Venetoclax Sequence 2 | Experimental | Participants will receive crushed venetoclax, followed by ground venetoclax, and completed with whole venetoclax for a 15 day period. Receives: Drug: Venetoclax |
| Venetoclax Sequence 3 | Experimental | Participants will receive ground venetoclax, followed by whole venetoclax, and completed with crushed venetoclax for a 15 day period. Receives: Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events
An adverse event is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measured: Up to 75 Days
Maximum Observed Plasma Concentration (Cmax) of Venetoclax
Cmax of venetoclax.
Measured: Up to 45 Days
Time to Cmax (Tmax) of Venetoclax
Tmax of venetoclax.
Measured: Up to 45 Days
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Venetoclax
AUCt of venetoclax.
Measured: Up to 45 Days
AUC From Time 0 to the Time Infinity (AUCinf) of Venetoclax
AUCinf of venetoclax.
Measured: Up to 45 Days
Apparent Terminal Phase Elimination Rate Constant (β) of Venetoclax
Apparent terminal phase elimination rate constant of venetoclax.
Measured: Up to 45 Days
Terminal Phase Elimination Half-life (t1/2) of Venetoclax
T1/2 of venetoclax.
Measured: Up to 45 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start15 Jun 2023
- Primary completion22 Sep 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT05909553
- Sponsor's protocol ID
- M24-301
- Status last verified
- Nov 2023
- First submitted
- 12 Jun 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alaei S, Wang Y, Liu Y, Schiele J, Deng R, Shiller D, Marroum P, Menon R, Salem AH. Venetoclax Clinical Pharmacokinetics After Administration of Crushed, Ground or Whole Tablets. Clin Ther. 2024 Oct;46(10):752-758. doi: 10.1016/j.clinthera.2024.03.012. Epub 2024 May 22.
PubMed 38782609
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate the Effect of Crushing and Grinding on the Bioavailability of Venetoclax Tablet in Healthy Adult Female Subjects
- ClinicalTrials.gov ID
- NCT05909553
- Acronym / sponsor ID
- M24-301
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, Venetoclax, ABT-199
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 18 Jun 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Venetoclax Sequence 1 | Experimental | Drug: VenetoclaxParticipants will receive whole venetoclax, followed by crushed venetoclax, and completed with ground venetoclax for a 15 day period. |
| Venetoclax Sequence 2 | Experimental | Drug: VenetoclaxParticipants will receive crushed venetoclax, followed by ground venetoclax, and completed with whole venetoclax for a 15 day period. |
| Venetoclax Sequence 3 | Experimental | Drug: VenetoclaxParticipants will receive ground venetoclax, followed by whole venetoclax, and completed with crushed venetoclax for a 15 day period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must either 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.
- 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).
Key exclusion criteria (3 listed)
- Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary or hepatic disease within the past 6 months that in the opinion of the investigator would adversely affect her participating in this study.
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption.
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 |
|---|---|---|
| VenetoclaxAlso: ABT-199, VenclaxtaOral; Tablet | Drug | Venetoclax Sequence 1, Venetoclax Sequence 2, Venetoclax Sequence 3 |
Primary outcome
Number of Participants Experiencing Adverse Events
Time frame: Up to 75 Days
An adverse event is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Maximum Observed Plasma Concentration (Cmax) of Venetoclax
Time frame: Up to 45 Days
Cmax of venetoclax.
Time to Cmax (Tmax) of Venetoclax
Time frame: Up to 45 Days
Tmax of venetoclax.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Venetoclax
Time frame: Up to 45 Days
AUCt of venetoclax.
AUC From Time 0 to the Time Infinity (AUCinf) of Venetoclax
Time frame: Up to 45 Days
AUCinf of venetoclax.
Apparent Terminal Phase Elimination Rate Constant (β) of Venetoclax
Time frame: Up to 45 Days
Apparent terminal phase elimination rate constant of venetoclax.
Terminal Phase Elimination Half-life (t1/2) of Venetoclax
Time frame: Up to 45 Days
T1/2 of venetoclax.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Derived from this study: PubMed 38782609Alaei S, Wang Y, Liu Y, Schiele J, Deng R, Shiller D, Marroum P, Menon R, Salem AH. Venetoclax Clinical Pharmacokinetics After Administration of Crushed, Ground or Whole Tablets. Clin Ther. 2024 Oct;46(10):752-758. doi: 10.1016/j.clinthera.2024.03.012. Epub 2024 May 22.
- Individual participant dataSharing planned: No
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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 2 inclusion and 3 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: finished, as of the sponsor's last update on 1 Dec 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants Experiencing Adverse Events (time frame: Up to 75 Days). 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?
On the ClinicalTrials.gov record for NCT05909553, which also lists 1 linked publication.
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 1 Dec 2023.