Not DeterminedPhase 1NCT06543043
A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax (BGB-11417) in Healthy Volunteers
A Phase 1 study testing Phenytoin, Itraconazole and sonrotoclax in people with Not Determined, run by BeiGene at 1 site in United States.
Trial summary
This is a single-center, open-label, parallel group study designed to investigate the effect of CYP3A induction and inhibition following multiple doses of phenytoin (Part A) and itraconazole (Part B), respectively, on the pharmacokinetics of sonrotoclax in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Not Determined
- What is being tested?
- Phenytoin, Itraconazole and sonrotoclax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2024to 7 Nov 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to understand and sign a written informed consent
- Able and willing to comply with all study requirements
- Healthy males or healthy females of non-childbearing potential
- Agrees to use an adequate method of contraception
- Body mass index (BMI) of 18.0 to 32.0 kg/m^2 as measured at screening or, if outside the range, considered not clinically significant by the investigator.
Who cannot join
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency (HIV) antibody results
- Prior treatment with sonrotoclax
- Evidence of renal impairment at screening
- Any contraindication to the use of phenytoin (Part A) or itraconazole (Part B)
- Current smokers and those who have smoked within the last 12 months
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
Show all 10Show fewer
- History of any drug or alcohol abuse in the past 2 years
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- History of clinically significant disorders as judged by the investigator
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Parallel Group Study Designed to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of Sonrotoclax (BGB-11417) in Healthy Subjects
This is a single-center, open-label, parallel group study designed to investigate the effect of CYP3A induction and inhibition following multiple doses of phenytoin (Part A) and itraconazole (Part B), respectively, on the pharmacokinetics of sonrotoclax in healthy volunteers.
- Conditions
- Not Determined
- Being tested
- Phenytoin, Itraconazole, sonrotoclax
- Keywords
- sonrotoclax, BGB-11417, healthy volunteers, phenytoin, itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenytoinDrug
Administered orally.
ItraconazoleDrug
Administered orally.
sonrotoclaxDrug
Also called BGB-11417
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Phenytoin + Sonrotoclax | Experimental | Part A is designed to determine the effect of multiple doses of phenytoin on sonrotoclax in healthy participants. Receives: Drug: Phenytoin; Drug: sonrotoclax |
| Part B: Itraconazole + Sonrotoclax | Experimental | Part B is designed to determine the effect of multiple doses of itraconazole on sonrotoclax in healthy participants. Receives: Drug: Itraconazole; Drug: sonrotoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts A and B: Lag time before observation of quantifiable concentrations in plasma (Tlag) of sonrotoclax
Measured: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Time to maximum observed concentration (Tmax) of sonrotoclax
Measured: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Maximum observed plasma concentration (Cmax) of sonrotoclax
Measured: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Area under the concentration time curve from time zero up to the last quantifiable concentration (AUClast) of sonrotoclax
Measured: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Area under the concentration time curve from time zero extrapolated to infinity (AUCinf) of sonrotoclax
Measured: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Terminal phase elimination rate constant (lambda-z) of sonrotoclax
Measured: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Terminal elimination half life (T1/2) of sonrotoclax
Measured: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Apparent oral clearance (CL/F) of sonrotoclax
Measured: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Apparent volume of distribution (Vz/F) of sonrotoclax
Measured: Approximately 21 days for Part A and 11 days for Part B
Secondary outcomes (1)
Parts A and B: Number of Participants with Adverse Events (AEs)
Number of participants with AEs and SAEs, including findings from vital signs, electrocardiograms (ECGs), physical examinations, and clinical laboratory assessments.
Measured: From time of providing written informed consent until up to 30 days after the final dose of study treatment for each part of the study; approximately 8 weeks for Part A and approximately 7 weeks for Part B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start19 Aug 2024
- Primary completion8 Oct 2024
- Study completion7 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Not DeterminedStudies of the same condition, open and under way.
- More trials run by BeiGeneThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543043
- Sponsor's protocol ID
- BGB-11417-107
- Other IDs
- QSC302214
- Status last verified
- Nov 2024
- First submitted
- 3 Aug 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Parallel Group Study Designed to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of Sonrotoclax (BGB-11417) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06543043
- Acronym / sponsor ID
- BGB-11417-107
- Conditions
- Not Determined
- Keywords
- sonrotoclax, BGB-11417, healthy volunteers, phenytoin, itraconazole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 7 Nov 2024 (actual)
- First posted
- 7 Aug 2024 (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.
This is a single-center, open-label, parallel group study designed to investigate the effect of CYP3A induction and inhibition following multiple doses of phenytoin (Part A) and itraconazole (Part B), respectively, on the pharmacokinetics of sonrotoclax in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Phenytoin + Sonrotoclax | Experimental | Drug: Phenytoin, Drug: sonrotoclaxPart A is designed to determine the effect of multiple doses of phenytoin on sonrotoclax in healthy participants. |
| Part B: Itraconazole + Sonrotoclax | Experimental | Drug: Itraconazole, Drug: sonrotoclaxPart B is designed to determine the effect of multiple doses of itraconazole on sonrotoclax in healthy participants. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able to understand and sign a written informed consent
- Able and willing to comply with all study requirements
- Healthy males or healthy females of non-childbearing potential
- Agrees to use an adequate method of contraception
- Body mass index (BMI) of 18.0 to 32.0 kg/m^2 as measured at screening or, if outside the range, considered not clinically significant by the investigator.
Key exclusion criteria (10 listed)
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency (HIV) antibody results
- Prior treatment with sonrotoclax
- Evidence of renal impairment at screening
- Any contraindication to the use of phenytoin (Part A) or itraconazole (Part B)
- Current smokers and those who have smoked within the last 12 months
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 |
|---|---|---|
| PhenytoinAdministered orally. | Drug | Part A: Phenytoin + Sonrotoclax |
| ItraconazoleAdministered orally. | Drug | Part B: Itraconazole + Sonrotoclax |
| sonrotoclaxAlso: BGB-11417Administered orally. | Drug | Part A: Phenytoin + Sonrotoclax, Part B: Itraconazole + Sonrotoclax |
Primary outcome
Parts A and B: Lag time before observation of quantifiable concentrations in plasma (Tlag) of sonrotoclax
Time frame: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Time to maximum observed concentration (Tmax) of sonrotoclax
Time frame: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Maximum observed plasma concentration (Cmax) of sonrotoclax
Time frame: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Area under the concentration time curve from time zero up to the last quantifiable concentration (AUClast) of sonrotoclax
Time frame: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Area under the concentration time curve from time zero extrapolated to infinity (AUCinf) of sonrotoclax
Time frame: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Terminal phase elimination rate constant (lambda-z) of sonrotoclax
Time frame: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Terminal elimination half life (T1/2) of sonrotoclax
Time frame: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Apparent oral clearance (CL/F) of sonrotoclax
Time frame: Approximately 21 days for Part A and 11 days for Part B
Parts A and B: Apparent volume of distribution (Vz/F) of sonrotoclax
Time frame: Approximately 21 days for Part A and 11 days for Part B
1 secondary outcome
Parts A and B: Number of Participants with Adverse Events (AEs)
Time frame: From time of providing written informed consent until up to 30 days after the final dose of study treatment for each part of the study; approximately 8 weeks for Part A and approximately 7 weeks for Part B
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 27 Nov 2024.
- Individual participant dataSharing planned: Yes
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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.
Study Director study director
BeiGene
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 Phenytoin, Itraconazole and sonrotoclax in people with Not Determined, run by BeiGene 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 5 inclusion and 10 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 27 Nov 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 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?
Parts A and B: Lag time before observation of quantifiable concentrations in plasma (Tlag) of sonrotoclax (time frame: Approximately 21 days for Part A and 11 days for Part B). The study lists 9 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 27 Nov 2024.