Healthy SubjectsPhase 1NCT03561298
A Pharmacokinetic Study to Assess Drug-drug Interaction Between Zanubrutinib and a Cocktail of Substrates in Healthy Subjects
A Phase 1 study testing BGB-3111 and Drug Cocktail in people with Healthy Subjects, run by BeiGene at 1 site in United States.
Trial summary
This study is designed to evaluate the safety and pharmacokinetic interaction of effects of multiple doses of zanubrutinib with a "Cocktail" of five probe drugs for cytochrome P450 (CYP) 3A, CYP2C9, CYP2C19, P-glycoprotein and breast cancer resistance protein (BCRP) in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- BGB-3111 and Drug Cocktail
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2018to 2 Jul 2018
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening.
- Subjects must have a body mass index (BMI) between 18 and 32 kg/m2.
- Male subjects must agree to a highly effective method of birth control from screening until at least 90 days after the last dose of study drug.
Who cannot join
- Subjects with a clinically relevant history or presence of any clinically significant disease.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).
- History of drug or alcohol abuse within 2 years prior to Check-In.
- Alcohol consumption of >21 units per week.
- A positive urine drug screen and/or positive alcohol breath test at Screening and/or Check-in.
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result and/or a positive human immunodeficiency virus (HIV) at screening.
- Use of tobacco- or nicotine-containing products within 3 months prior to Check-In.
- History of blood donation of 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit
Daytona Beach, Florida, 32117
About this study
Official title: An Open-label, Fixed-Sequence Study in Healthy Male Subjects to Assess the Drug Interaction Potential of Multiple Doses of Zanubrutinib With a Drug "Cocktail" Representative for CYP3A4, CYP2C9, CYP2C19, P-gP and BCRP Substrates
This study is designed to evaluate the safety and pharmacokinetic interaction of effects of multiple doses of zanubrutinib with a "Cocktail" of five probe drugs for cytochrome P450 (CYP) 3A, CYP2C9, CYP2C19, P-glycoprotein and breast cancer resistance protein (BCRP) in healthy subjects
- Conditions
- Healthy Subjects
- Being tested
- BGB-3111 and Drug Cocktail
- Keywords
- Pharmacokinetics, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-3111 and Drug CocktailDrug
BGB-3111 and Drug Cocktail (midazolam, warfarin, omeprazole, digoxin and rosuvastatin)
| Study group | Role | What they receive |
|---|---|---|
| Single Arm: BGB-3111 + Drug Cocktail | Experimental | BGB-3111 and Drug Cocktail (midazolam, warfarin, omeprazole, digoxin and rosuvastatin) Receives: Drug: BGB-3111 and Drug Cocktail |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters of probe drugs (warfarin, midazolam, digoxin, rosuvastatin, and omeprazole) derived from the plasma concentration time profile before and after oral administration of zanubrutinib
AUC from time 0 to the last quantifiable concentration (AUC0-t)
Measured: Days 1-20
PK parameters of probe drugs (warfarin, midazolam, digoxin, rosuvastatin, and omeprazole) derived from the plasma concentration time profile before and after oral administration of zanubrutinib
AUC from time 0 to infinity (AUC0 ∞; calculated as appropriate and allowed by the available data)
Measured: Days 1-20
PK parameters of probe drugs (warfarin, midazolam, digoxin, rosuvastatin, and omeprazole) derived from the plasma concentration time profile before and after oral administration of zanubrutinib
Maximum observed plasma concentration (Cmax)
Measured: Days 1-20
PK parameters of probe drugs (warfarin, midazolam, digoxin, rosuvastatin, and omeprazole) derived from the plasma concentration time profile before and after oral administration of zanubrutinib
Time of the maximum observed plasma concentration (Tmax)
Measured: Days 1-20
Secondary outcomes (1)
Number of participants with adverse events as a measure of safety and tolerability.
An adverse event is an unfavorable and unintended sign (including an abnormal laboratory finding, an abnormal electrocardiogram), symptom or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not.
Measured: up to 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start7 Jun 2018
- Primary completion7 Jun 2018
- Study completion2 Jul 2018
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 SubjectsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Novotny, MD, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561298
- Sponsor's protocol ID
- BGB-3111-108
- Status last verified
- Oct 2018
- First submitted
- 24 May 2018
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen D, Wei XT, Meng X, Alexander L, Ryan K, Jang S. Effect of Rivoceranib 200 mg Once Daily on the Pharmacokinetics of a Cocktail Probe Substrate of Cytochrome P450 Enzymes: A Phase I Trial in Healthy Volunteers. Clin Pharmacokinet. 2026 Aug 29. doi: 10.1007/s40262-026-01686-6. Online ahead of print.
PubMed 42667590
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Fixed-Sequence Study in Healthy Male Subjects to Assess the Drug Interaction Potential of Multiple Doses of Zanubrutinib With a Drug "Cocktail" Representative for CYP3A4, CYP2C9, CYP2C19, P-gP and BCRP Substrates
- ClinicalTrials.gov ID
- NCT03561298
- Acronym / sponsor ID
- BGB-3111-108
- Conditions
- Healthy Subjects
- Keywords
- Pharmacokinetics, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 7 Jun 2018 (actual)
- Study completion
- 2 Jul 2018 (actual)
- First posted
- 19 Jun 2018 (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 study is designed to evaluate the safety and pharmacokinetic interaction of effects of multiple doses of zanubrutinib with a "Cocktail" of five probe drugs for cytochrome P450 (CYP) 3A, CYP2C9, CYP2C19, P-glycoprotein and breast cancer resistance protein (BCRP) in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm: BGB-3111 + Drug Cocktail | Experimental | Drug: BGB-3111 and Drug CocktailBGB-3111 and Drug Cocktail (midazolam, warfarin, omeprazole, digoxin and rosuvastatin) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male subjects in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening.
- Subjects must have a body mass index (BMI) between 18 and 32 kg/m2.
- Male subjects must agree to a highly effective method of birth control from screening until at least 90 days after the last dose of study drug.
Key exclusion criteria (8 listed)
- Subjects with a clinically relevant history or presence of any clinically significant disease.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).
- History of drug or alcohol abuse within 2 years prior to Check-In.
- Alcohol consumption of >21 units per week.
- A positive urine drug screen and/or positive alcohol breath test at Screening and/or Check-in.
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 |
|---|---|---|
| BGB-3111 and Drug CocktailBGB-3111 and Drug Cocktail (midazolam, warfarin, omeprazole, digoxin and rosuvastatin) | Drug | Single Arm: BGB-3111 + Drug Cocktail |
Primary outcome
PK parameters of probe drugs (warfarin, midazolam, digoxin, rosuvastatin, and omeprazole) derived from the plasma concentration time profile before and after oral administration of zanubrutinib
Time frame: Days 1-20
AUC from time 0 to the last quantifiable concentration (AUC0-t)
PK parameters of probe drugs (warfarin, midazolam, digoxin, rosuvastatin, and omeprazole) derived from the plasma concentration time profile before and after oral administration of zanubrutinib
Time frame: Days 1-20
AUC from time 0 to infinity (AUC0 ∞; calculated as appropriate and allowed by the available data)
PK parameters of probe drugs (warfarin, midazolam, digoxin, rosuvastatin, and omeprazole) derived from the plasma concentration time profile before and after oral administration of zanubrutinib
Time frame: Days 1-20
Maximum observed plasma concentration (Cmax)
PK parameters of probe drugs (warfarin, midazolam, digoxin, rosuvastatin, and omeprazole) derived from the plasma concentration time profile before and after oral administration of zanubrutinib
Time frame: Days 1-20
Time of the maximum observed plasma concentration (Tmax)
1 secondary outcome
Number of participants with adverse events as a measure of safety and tolerability.
Time frame: up to 26 days
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 4 Nov 2019.
- Derived from this study: PubMed 42667590Nguyen D, Wei XT, Meng X, Alexander L, Ryan K, Jang S. Effect of Rivoceranib 200 mg Once Daily on the Pharmacokinetics of a Cocktail Probe Substrate of Cytochrome P450 Enzymes: A Phase I Trial in Healthy Volunteers. Clin Pharmacokinet. 2026 Aug 29. doi: 10.1007/s40262-026-01686-6. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
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.
William Novotny, MD 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 BGB-3111 and Drug Cocktail in people with Healthy Subjects, 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 3 inclusion and 8 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 4 Nov 2019. 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?
PK parameters of probe drugs (warfarin, midazolam, digoxin, rosuvastatin, and omeprazole) derived from the plasma concentration time profile before and after oral administration of zanubrutinib (time frame: Days 1-20). The study lists 4 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 NCT03561298, 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 4 Nov 2019.