Healthy VolunteersPhase 1NCT03432884
A Two-Part Phase 1 Study to Investigate the Safety and Tolerability of Supratherapeutic Dose of Zanubrutinib and Effect of Zanubrutinib on Cardiac Repolarization in Healthy Subjects
A Phase 1 study testing BGB-3111 and Moxifloxacin in people with Healthy Volunteers, run by BeiGene at 1 site in United States.
Trial summary
A Two-Part Phase 1 Study to Investigate A) Safety and Tolerability of Supratherapeutic dose of Zanubrutinib (BGB-3111) and B) Effect of Zanubrutinib on Cardiac Repolarization in Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BGB-3111 and Moxifloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2018to 16 Apr 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) 18 - 33 kg/m2, inclusive.
- In good general health as assessed by the Investigator.
- Females of non-child bearing potential.
- Males without a vasectomy will agree to use required barrier contraception, and will agree to not donate sperm from the time of the first dose of BGB-3111 until ≥ 90 days after the last dose of BGB-3111.
- Able to comprehend and willing to sign consent.
Who cannot join
- Subjects with a clinically relevant history or presence of any clinically significant disease.
- Personal or known family history of congenital or acquired long QT syndrome or cardiovascular disease.
- Women of child-bearing potential.
- History of alcoholism or drug/chemical abuse within 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Services, Inc.
Secaucus, New Jersey, 07094
About this study
Official title: A Two-Part Study Consisting of a Randomized, Placebo-Controlled, Single Dose Safety and Tolerability Study (Part A) Evaluating a Supratherapeutic Dose of Zanubrutinib Followed by a Randomized, Placebo- and Positive-Controlled, Crossover Study (Part B) to Evaluate the Effect of Zanubrutinib on Cardiac Repolarization in Healthy Volunteers
A Two-Part Phase 1 Study to Investigate A) Safety and Tolerability of Supratherapeutic dose of Zanubrutinib (BGB-3111) and B) Effect of Zanubrutinib on Cardiac Repolarization in Healthy Subjects
Read the detailed description
This is a Two-Part Phase 1 Study.
Part A: This is a randomized, placebo-controlled, double blind, single dose study to evaluate the safety and tolerability of a single oral supratherapeutic dose of zanubrutinib in eight (8) subjects.
Part B: This is a randomized, placebo and positive-controlled, double-blind, 4-way crossover study being conducted in about 28 subjects to investigate the effect of a single therapeutic dose of zanubrutinib, a supratherapeutic dose of zanubrutinib and placebo on cardiac repolarization. Open-label Moxifloxacin (400 mg), a fluoroquinolone broad spectrum antibiotic will be used as a positive control.
- Conditions
- Healthy Volunteers
- Being tested
- BGB-3111, Placebo, Moxifloxacin
- Keywords
- Phase 1, pharmacokinetics, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-3111Drug
Subjects will receive BGB-3111
PlaceboDrug
Subjects will receive Placebo
MoxifloxacinDrug
Also called Avelox
Subjects will receive Moxifloxicin
| Study group | Role | What they receive |
|---|---|---|
| Part A: BGB-3111 | Experimental | Not described Receives: Drug: BGB-3111 |
| Part A: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Part B: BGB-3111, Placebo, and Moxifloxicin | Experimental | Not described Receives: Drug: BGB-3111; Drug: Placebo; Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Incidence of treatment-emergent adverse events (safety and tolerability)
Incidence of treatment-emergent adverse events reported for zanubrutinib compared with placebo
Measured: Up to 8 days
Part B: Corrected QT interval [QTc]
Evaluate the effects of single doses of zanubrutinib on the corrected QT interval [QTc] using the Fridericia correction [QTcF]) compared with placebo
Measured: Up to 2 days
Secondary outcomes (6)
Part A: PK Parameters
Plasma concentrations of zanubrutinib to evaluate protocol specified PK parameters
Measured: Up to 3 days
Part B: Heart Rate (HR)
Evaluate the effects of a single dose of zanubrutinib and a single supratherapeutic dose of zanubrutinib on heart rate (HR)
Measured: Up to 2 days
Part B: PR Intervals
Evaluate the effects of a single dose of zanubrutinib and a single supratherapeutic dose of zanubrutinib on PR
Measured: Up to 2 days
Part B: QRS Intervals
Evaluate the effects of a single dose of zanubrutinib and a single supratherapeutic dose of zanubrutinib on QRS Intervals
Measured: Up to 2 days
Part B: PK Parameters
Plasma concentrations of zanubrutinib to evaluate protocol specified PK parameters
Measured: Up to 2 days
Part B: Incidence of treatment-emergent adverse events (safety and tolerability)
Incidence of treatment-emergent adverse events reported for zanubrutinib
Measured: Up to 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start25 Jan 2018
- Primary completion16 Apr 2018
- Study completion16 Apr 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 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Part A: Single Group Part B: Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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
- NCT03432884
- Sponsor's protocol ID
- BGB-3111-106
- Status last verified
- Apr 2020
- First submitted
- 19 Jan 2018
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mu S, Darpo B, Tang Z, Novotny W, Tawashi M, Xue H, Willett M, Lin L, Sahasranaman S, Ou YC. No QTc Prolongation With Zanubrutinib: Results of Concentration-QTc Analysis From a Thorough QT Study in Healthy Subjects. Clin Transl Sci. 2020 Sep;13(5):923-931. doi: 10.1111/cts.12779. Epub 2020 Apr 8.
PubMed 32144955
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part Study Consisting of a Randomized, Placebo-Controlled, Single Dose Safety and Tolerability Study (Part A) Evaluating a Supratherapeutic Dose of Zanubrutinib Followed by a Randomized, Placebo- and Positive-Controlled, Crossover Study (Part B) to Evaluate the Effect of Zanubrutinib on Cardiac Repolarization in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03432884
- Acronym / sponsor ID
- BGB-3111-106
- Conditions
- Healthy Volunteers
- Keywords
- Phase 1, pharmacokinetics, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 16 Apr 2018 (actual)
- First posted
- 14 Feb 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.
A Two-Part Phase 1 Study to Investigate A) Safety and Tolerability of Supratherapeutic dose of Zanubrutinib (BGB-3111) and B) Effect of Zanubrutinib on Cardiac Repolarization in Healthy Subjects
Detailed description
This is a Two-Part Phase 1 Study.
Part A: This is a randomized, placebo-controlled, double blind, single dose study to evaluate the safety and tolerability of a single oral supratherapeutic dose of zanubrutinib in eight (8) subjects.
Part B: This is a randomized, placebo and positive-controlled, double-blind, 4-way crossover study being conducted in about 28 subjects to investigate the effect of a single therapeutic dose of zanubrutinib, a supratherapeutic dose of zanubrutinib and placebo on cardiac repolarization. Open-label Moxifloxacin (400 mg), a fluoroquinolone broad spectrum antibiotic will be used as a positive control.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Part A: Single Group Part B: Crossover
| Arm | Type | Receives |
|---|---|---|
| Part A: BGB-3111 | Experimental | Drug: BGB-3111 |
| Part A: Placebo | Placebo comparator | Drug: Placebo |
| Part B: BGB-3111, Placebo, and Moxifloxicin | Experimental | Drug: BGB-3111, Drug: Placebo, Drug: Moxifloxacin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index (BMI) 18 - 33 kg/m2, inclusive.
- In good general health as assessed by the Investigator.
- Females of non-child bearing potential.
- Males without a vasectomy will agree to use required barrier contraception, and will agree to not donate sperm from the time of the first dose of BGB-3111 until ≥ 90 days after the last dose of BGB-3111.
- Able to comprehend and willing to sign consent.
Key exclusion criteria (4 listed)
- Subjects with a clinically relevant history or presence of any clinically significant disease.
- Personal or known family history of congenital or acquired long QT syndrome or cardiovascular disease.
- Women of child-bearing potential.
- History of alcoholism or drug/chemical abuse within 6 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 |
|---|---|---|
| BGB-3111Subjects will receive BGB-3111 | Drug | Part A: BGB-3111, Part B: BGB-3111, Placebo, and Moxifloxicin |
| PlaceboSubjects will receive Placebo | Drug | Part A: Placebo, Part B: BGB-3111, Placebo, and Moxifloxicin |
| MoxifloxacinAlso: AveloxSubjects will receive Moxifloxicin | Drug | Part B: BGB-3111, Placebo, and Moxifloxicin |
Primary outcome
Part A: Incidence of treatment-emergent adverse events (safety and tolerability)
Time frame: Up to 8 days
Incidence of treatment-emergent adverse events reported for zanubrutinib compared with placebo
Part B: Corrected QT interval [QTc]
Time frame: Up to 2 days
Evaluate the effects of single doses of zanubrutinib on the corrected QT interval [QTc] using the Fridericia correction [QTcF]) compared with placebo
6 secondary outcomes
Part A: PK Parameters
Time frame: Up to 3 days
Part B: Heart Rate (HR)
Time frame: Up to 2 days
Part B: PR Intervals
Time frame: Up to 2 days
Part B: QRS Intervals
Time frame: Up to 2 days
Part B: PK Parameters
Time frame: Up to 2 days
Part B: Incidence of treatment-emergent adverse events (safety and tolerability)
Time frame: Up to 16 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 24 Apr 2020.
- Results publication: PubMed 32144955Mu S, Darpo B, Tang Z, Novotny W, Tawashi M, Xue H, Willett M, Lin L, Sahasranaman S, Ou YC. No QTc Prolongation With Zanubrutinib: Results of Concentration-QTc Analysis From a Thorough QT Study in Healthy Subjects. Clin Transl Sci. 2020 Sep;13(5):923-931. doi: 10.1111/cts.12779. Epub 2020 Apr 8.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Volunteers
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
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 Moxifloxacin 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 4 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 24 Apr 2020. 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. Some participants in this study may receive a placebo. 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?
Part A: Incidence of treatment-emergent adverse events (safety and tolerability) (time frame: Up to 8 days). The study lists 2 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 NCT03432884, 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 24 Apr 2020.