Healthy VolunteersPhase 1NCT05844111
A Study to Investigate the Absorption, Metabolism and Excretion of [14C]-BGB-11417
A Phase 1 study testing [14C]-BGB-11417 in people with Healthy Volunteers, run by BeiGene at 1 site in United States.
Trial summary
The main objective of this study is to determine the mass balance, routes of elimination, and pharmacokinetics of [14C]-BGB-11417 in healthy male participants along with determining the concentrations of radioactivity in plasma, fecal and urinary elimination of total radioactivity. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C]-BGB-11417
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2023to 18 Jun 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participant is judged by the investigator to be in good general health, as determined by no clinically significant findings from medical history, clinical laboratory assessments, vital sign measurements, 12-Lead electrocardiogram (ECG), and physical examination at screening and check-in
- The participant has a body mass index from 18.0 to 35.0 kilograms per square meter (kg/m^2), inclusive, at screening
- The participant has normal hepatic function (Note: Participants with Gilbert's syndrome should not be included)
- Participants must be willing to follow contraceptive practices, as applicable, from check-in until 90 days following study drug administration
- Participants must be willing to refrain from donating sperm from check-in until 90 days following study drug administration
Who cannot join
- The participant has an absolute B-lymphocyte count of <200 cells/μL
- The participant has a medical history of any issues affecting swallowing, absorption, or metabolism, as judged by the investigator
- The participant has a medical history of any problems affecting venous access or bowel/bladder function
- The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening
- The participant is a smoker or has used nicotine or nicotine-containing products within 6 months before the first dose of study drug
- The subject has creatinine clearance of <90 mL/min, calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
Show all 13Show fewer
- The participant has used any prescription or over-the-counter medications (except acetaminophen [up to 2 grams per day]), including herbal or nutritional supplements, within 14 days before the first dose of study drug
- The participant received any treatment with a moderate CYP3A4 inhibitor or strong CYP3A4 inducer within 14 days (or 5 half-lives, whichever is longer) before the first dose of study drug or during the study
- The participant has consumed grapefruit or grapefruit juice, Seville orange or Seville-orange-containing products (eg, marmalade), or caffeine- or xanthine-containing products within 48 hours before the first dose of study drug or during the study
- The participant has a history of alcohol abuse or drug addiction or psychiatric disorders including major depression disorder within the last year or excessive alcohol consumption (regular alcohol intake >21 units per week) (1 unit is equal to approximately one-half pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits
- The participant has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug.
- The participant is involved in strenuous activity or contact sports within 24 hours before the first dose of study drug or during the study
- Note: Other inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study To Investigate The Absorption, Metabolism, and Excretion of [14C]-BGB-11417 Following Single Oral Dose Administration in Healthy Male Subjects
The main objective of this study is to determine the mass balance, routes of elimination, and pharmacokinetics of [14C]-BGB-11417 in healthy male participants along with determining the concentrations of radioactivity in plasma, fecal and urinary elimination of total radioactivity.
- Conditions
- Healthy Volunteers
- Being tested
- [14C]-BGB-11417
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-BGB-11417Drug
Also called Sonrotoclax
A single oral dose of liquid formulation
| Study group | Role | What they receive |
|---|---|---|
| [14C] radiolabeled BGB-11417 | Experimental | Participants will receive a single dose of [14C]-BGB-11417 Receives: Drug: [14C]-BGB-11417 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of BGB-11417
Measured: From 0 to 168 hours after study drug administration
Maximum concentration (Cmax) of BGB-11417 in Plasma
Measured: From 0 to 168 hours after study drug administration
Time to Cmax (Tmax) of BGB-11417 in Plasma
Measured: From 0 to 168 hours after study drug administration
Amount of BGB-11417-106 excreted (Ae) and Cumulative amount of BGB-11417-106 (Cum Ae) excreted in urine and feces
Measured: From 0 to 168 hours after study drug administration
Percentage (%Fe) and cumulative percentage (Cum %Fe) of BGB-11417 or radioactive dose excreted in urine and feces
Measured: From 0 to 168 hours after study drug administration
Secondary outcomes (1)
Number of participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: From the day of screening until end of study (approximately 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start22 May 2023
- Primary completion18 Jun 2023
- Study completion18 Jun 2023
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 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844111
- Sponsor's protocol ID
- BGB-11417-106
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2023
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study To Investigate The Absorption, Metabolism, and Excretion of [14C]-BGB-11417 Following Single Oral Dose Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05844111
- Acronym / sponsor ID
- BGB-11417-106
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 22 May 2023 (actual)
- Primary completion
- 18 Jun 2023 (actual)
- Study completion
- 18 Jun 2023 (actual)
- First posted
- 6 May 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 main objective of this study is to determine the mass balance, routes of elimination, and pharmacokinetics of [14C]-BGB-11417 in healthy male participants along with determining the concentrations of radioactivity in plasma, fecal and urinary elimination of total radioactivity.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C] radiolabeled BGB-11417 | Experimental | Drug: [14C]-BGB-11417Participants will receive a single dose of [14C]-BGB-11417 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The participant is judged by the investigator to be in good general health, as determined by no clinically significant findings from medical history, clinical laboratory assessments, vital sign measurements, 12-Lead electrocardiogram (ECG), and physical examination at screening and check-in
- The participant has a body mass index from 18.0 to 35.0 kilograms per square meter (kg/m^2), inclusive, at screening
- The participant has normal hepatic function (Note: Participants with Gilbert's syndrome should not be included)
- Participants must be willing to follow contraceptive practices, as applicable, from check-in until 90 days following study drug administration
- Participants must be willing to refrain from donating sperm from check-in until 90 days following study drug administration
Key exclusion criteria (13 listed)
- The participant has an absolute B-lymphocyte count of <200 cells/μL
- The participant has a medical history of any issues affecting swallowing, absorption, or metabolism, as judged by the investigator
- The participant has a medical history of any problems affecting venous access or bowel/bladder function
- The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening
- The participant is a smoker or has used nicotine or nicotine-containing products within 6 months before 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 |
|---|---|---|
| [14C]-BGB-11417Also: SonrotoclaxA single oral dose of liquid formulation | Drug | [14C] radiolabeled BGB-11417 |
Primary outcome
Area under the concentration curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of BGB-11417
Time frame: From 0 to 168 hours after study drug administration
Maximum concentration (Cmax) of BGB-11417 in Plasma
Time frame: From 0 to 168 hours after study drug administration
Time to Cmax (Tmax) of BGB-11417 in Plasma
Time frame: From 0 to 168 hours after study drug administration
Amount of BGB-11417-106 excreted (Ae) and Cumulative amount of BGB-11417-106 (Cum Ae) excreted in urine and feces
Time frame: From 0 to 168 hours after study drug administration
Percentage (%Fe) and cumulative percentage (Cum %Fe) of BGB-11417 or radioactive dose excreted in urine and feces
Time frame: From 0 to 168 hours after study drug administration
1 secondary outcome
Number of participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From the day of screening until end of study (approximately 1 month)
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 17 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 [14C]-BGB-11417 in people with Healthy Volunteers, 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 13 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 17 Apr 2025. 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?
Area under the concentration curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of BGB-11417 (time frame: From 0 to 168 hours after study drug administration). The study lists 5 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 17 Apr 2025.