Healthy Volunteers: Asian, Non-AsianPhase 1NCT03301181
Phase 1 Study to Investigate Effect of Rifampin and Itraconazole on the Pharmacokinetics of BGB-3111 in Healthy Subjects
A Phase 1 study testing BGB-3111 (Arm A), Rifampin and BGB-3111 (Arm B) in people with Healthy Volunteers: Asian, Non-Asian, run by BeiGene at 1 site in United States.
Trial summary
Phase 1 study in healthy subjects to determine the effect of rifampin (Part A) or itraconazole (Part B) on the pharmacokinetics of BGB-3111 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers: Asian, Non-Asian
- What is being tested?
- BGB-3111 (Arm A), Rifampin and BGB-3111 (Arm B)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2017to 13 Nov 2017
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI)18 - 32 kg/m2, inclusive.
- Subjects of Asian (first- or second-generation) and non-Asian descent.
- In good general health as assessed by the Investigator.
- Females must be nonpregnant and nonlactating, and females of childbearing potential will agree to use required contraception.
- 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.
- Evidence of bacterial, viral, fungal, parasitic infections within 4 weeks prior to the first dose of study drug.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
- History of alcoholism or drug/chemical abuse within prior year.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Coast Clinical Trials (WCCT)
Cypress, California, 90630
About this study
Official title: A Phase 1, Open-label, Parallel-group, Fixed-sequence Study to Investigate the Effect of the CYP3A Inducer Rifampin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-3111 in Healthy Subjects
Phase 1 study in healthy subjects to determine the effect of rifampin (Part A) or itraconazole (Part B) on the pharmacokinetics of BGB-3111
Read the detailed description
This is a Phase 1 open-label, parallel-group study in healthy subjects. Subjects in Part A will receive a single dose of BGB-3111 before and during consecutive daily doses of strong cytochrome P450 CYP3A inducer, rifampin, to investigate its effect on the pharmacokinetics of BGB-3111. Following an interim data analysis, subjects in Part B will receive a single dose of BGB-3111 before and during consecutive daily doses of strong CYP3A inhibitor, itraconazole, to investigate its effect on the pharmacokinetics of BGB-3111.
- Conditions
- Healthy Volunteers: Asian, Non-Asian
- Being tested
- BGB-3111 (Arm A), Rifampin, BGB-3111 (Arm B), Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-3111 (Arm A)Drug
320 mg BGB-3111 single oral dose
RifampinDrug
Also called Rifadin, Rimactane
600 mg rifampin once daily
BGB-3111 (Arm B)Drug
Up to 80 mg BGB-3111 single oral dose
ItraconazoleDrug
Also called Sporanox, Orungal
200 mg itraconazole once daily
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Approximately 20 subjects to receive BGB-3111 and rifampin Receives: Drug: BGB-3111 (Arm A); Drug: Rifampin |
| Arm B | Experimental | Approximately 20 subjects to receive BGB-3111 and itraconazole Receives: Drug: BGB-3111 (Arm B); Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of BGB-3111 and rifampin to evaluate protocol specified PK parameters
Measured: Part A: Days 1 and 10
Plasma concentration of BGB-3111 and itraconazole to evaluate protocol specified PK parameters
Measured: Part B: Days 1 and 6
Secondary outcomes (2)
Safety as assessed by adverse events
Measured: Part A: up to 19 days: Part B: up to 14 days
Safety as assessed by electrocardiogram (ECG) measurements
Measured: Part A: Days 1 and 10, from screening to end of study visit; up to Day 19; Part B: Days 1 and 6, from screening to end of study visit; up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start18 Sep 2017
- Primary completion7 Nov 2017
- Study completion13 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers: Asian, Non-AsianStudies 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
- 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
- NCT03301181
- Sponsor's protocol ID
- BGB-3111-104
- Status last verified
- Jun 2018
- First submitted
- 29 Sep 2017
- Last updated
- 1 Nov 2019
- 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 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Parallel-group, Fixed-sequence Study to Investigate the Effect of the CYP3A Inducer Rifampin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-3111 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03301181
- Acronym / sponsor ID
- BGB-3111-104
- Conditions
- Healthy Volunteers: Asian, Non-Asian
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 7 Nov 2017 (actual)
- Study completion
- 13 Nov 2017 (actual)
- First posted
- 4 Oct 2017 (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.
Phase 1 study in healthy subjects to determine the effect of rifampin (Part A) or itraconazole (Part B) on the pharmacokinetics of BGB-3111
Detailed description
This is a Phase 1 open-label, parallel-group study in healthy subjects. Subjects in Part A will receive a single dose of BGB-3111 before and during consecutive daily doses of strong cytochrome P450 CYP3A inducer, rifampin, to investigate its effect on the pharmacokinetics of BGB-3111. Following an interim data analysis, subjects in Part B will receive a single dose of BGB-3111 before and during consecutive daily doses of strong CYP3A inhibitor, itraconazole, to investigate its effect on the pharmacokinetics of BGB-3111.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: BGB-3111 (Arm A), Drug: RifampinApproximately 20 subjects to receive BGB-3111 and rifampin |
| Arm B | Experimental | Drug: BGB-3111 (Arm B), Drug: ItraconazoleApproximately 20 subjects to receive BGB-3111 and itraconazole |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body mass index (BMI)18 - 32 kg/m2, inclusive.
- Subjects of Asian (first- or second-generation) and non-Asian descent.
- In good general health as assessed by the Investigator.
- Females must be nonpregnant and nonlactating, and females of childbearing potential will agree to use required contraception.
- 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 (5 listed)
- Subjects with a clinically relevant history or presence of any clinically significant disease.
- Evidence of bacterial, viral, fungal, parasitic infections within 4 weeks prior to the first dose of study drug.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
- History of alcoholism or drug/chemical abuse within prior year.
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 (Arm A)320 mg BGB-3111 single oral dose | Drug | Arm A |
| RifampinAlso: Rifadin, Rimactane600 mg rifampin once daily | Drug | Arm A |
| BGB-3111 (Arm B)Up to 80 mg BGB-3111 single oral dose | Drug | Arm B |
| ItraconazoleAlso: Sporanox, Orungal200 mg itraconazole once daily | Drug | Arm B |
Primary outcome
Plasma concentration of BGB-3111 and rifampin to evaluate protocol specified PK parameters
Time frame: Part A: Days 1 and 10
Plasma concentration of BGB-3111 and itraconazole to evaluate protocol specified PK parameters
Time frame: Part B: Days 1 and 6
2 secondary outcomes
Safety as assessed by adverse events
Time frame: Part A: up to 19 days: Part B: up to 14 days
Safety as assessed by electrocardiogram (ECG) measurements
Time frame: Part A: Days 1 and 10, from screening to end of study visit; up to Day 19; Part B: Days 1 and 6, from screening to end of study visit; up to Day 14
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 Nov 2019.
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 (Arm A), Rifampin and BGB-3111 (Arm B) in people with Healthy Volunteers: Asian, Non-Asian, 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 5 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 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?
Plasma concentration of BGB-3111 and rifampin to evaluate protocol specified PK parameters (time frame: Part A: Days 1 and 10). 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?
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 Nov 2019.