Healthy VolunteersPhase 1NCT04163783
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-BGB-3111 in Healthy Males
A Phase 1 study testing [14C]-BGB-3111 and BGB-3111 in people with Healthy Volunteers, run by BeiGene at 1 site in United States.
Trial summary
Phase 1 study in healthy subjects to determine the effect of an 8-hour fast from food on the pharmacokinetics of [14C]-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
- What is being tested?
- [14C]-BGB-3111 and BGB-3111
- 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
- 29 Mar 2017to 18 Apr 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
- Male between 18 and 65 years of age, inclusive, at Screening
- Body mass index between 18.0 and 35.0 kg/m2, inclusive, at Screening
- In good health, determined by no clinically significant findings from medical history,12-lead ECGs, or vital signs measurements
- Clinical laboratory evaluations
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, infectious, dermatological, hepatic, renal, hematological, pulmonary, metabolic, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator [or designee]) prior to Check-in
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) prior to Check-in
- History of stomach or intestinal surgery or resection that could alter absorption or excretion of orally administered drugs prior to Check-in except that appendectomy and hernia repair will be allowed if it was not associated with complications
- Abnormal liver function tests
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit, Inc.,
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-BGB-3111 Following Single Oral Dose Administration in Healthy Male Subjects
Phase 1 study in healthy subjects to determine the effect of an 8-hour fast from food on the pharmacokinetics of [14C]-BGB-3111.
Read the detailed description
This study will be an open-label, non-randomized study to evaluate the pharmacokinetics of [14C]-BGB-3111 when administered in healthy male subjects following at least an 8-hour fast from food (not including water).
- Conditions
- Healthy Volunteers
- Being tested
- [14C]-BGB-3111, BGB-3111
- Keywords
- Phase 1, Pharmacokinetics, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-BGB-3111Drug
20-mg capsule containing ~200 μCi of [14C]-BGB-3111,
BGB-3111Drug
Three 20-mg capsules of BGB-3111 and three 80-mg capsules of BGB-3111
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Subjects will be administered a single oral dose of 320 mg of [14C]-BGB-3111 Receives: Drug: [14C]-BGB-3111; Drug: BGB-3111 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameter: Plasma concentration of [14C]-BGB-3111 as measured by area under concentration-time curve (AUC)
Measured: Up to 13 days
Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) of [14C]-BGB-3111
Measured: Up to 13 days
Pharmacokinetic Parameter: Time To Maximum Plasma Concentration (Tmax) of [14C]-BGB-3111
Measured: Up to 13 days
Pharmacokinetic Parameter: apparent terminal elimination rate constant (λZ) of [14C]-BGB-3111
Measured: Up to 13 days
Pharmacokinetic Parameter: Half-life Period of (T1/2) of [14C]-BGB-3111
Measured: Up to 13 days
Pharmacokinetic Parameter: apparent systemic clearance (CL/F) of [14C]-BGB-3111
Measured: Up to 13 days
Pharmacokinetic Parameter: apparent volume of distribution during the terminal phase (Vz/F) of [14C]-BGB-3111
Measured: Up to 13 days
Blood and plasma concentrations of total radioactivity: Maximum Plasma Concentration (Cmax) of [14C]-BGB-3111
Measured: Up to 13 days
Blood and plasma concentrations of total radioactivity: Time To Maximum Plasma Concentration (Tmax) of [14C]-BGB-3111
Measured: Up to 13 days
Blood and plasma concentrations of total radioactivity of [14C]-BGB-3111 as measured by area under concentration-time curve (AUC)
Measured: Up to 13 days
Blood and plasma concentrations of total radioactivity: apparent terminal elimination rate constant (λZ) of [14C]-BGB-3111
Measured: Up to 13 days
Blood and plasma concentrations of total radioactivity: Half-life Period of (T1/2) of [14C]-BGB-3111
Measured: Up to 13 days
Blood and plasma concentrations of total radioactivity: apparent systemic clearance (CL/F) of [14C]-BGB-3111
Measured: Up to 13 days
Blood and plasma concentrations of total radioactivity: apparent volume of distribution during the terminal phase (Vz/F) of [14C]-BGB-3111
Measured: Up to 13 days
Urinary recovery of total radioactivity of [14C]-BGB-3111 as assessed by the amount excreted in urine per sampling interval (Aeu)
Measured: Up to 13 days
Urinary recovery of total radioactivity of [14C]-BGB-3111 as assessed by the cumulative amount excreted in urine per sampling interval (Cum Aeu)
Measured: Up to 13 days
Urinary recovery of total radioactivity of [14C]-BGB-3111 as assessed by the percentage of drug or radioactive dose excreted in urine per sampling interval (%Feu)
Measured: Up to 13 days
Urinary recovery of total radioactivity of [14C]-BGB-3111 as assessed by the cumulative percentage of drug or radioactive dose excreted in urine (Cum %Feu)
Measured: Up to 13 days
Urinary recovery of total radioactivity as assessed by the renal clearance (CLR; for BGB-3111 only)
Measured: Up to 13 days
Fecal recovery of total radioactivity as assessed by the amount of [14C]-BGB-3111 excreted in feces per sampling interval (Aef)
Measured: Up to 13 days
Fecal recovery of total radioactivity as assessed by the cumulative amount of [14C]-BGB-3111 excreted in feces per sampling interval (Cum Aef)
Measured: Up to 13 days
Fecal recovery of total radioactivity as assessed by the percentage of radioactive dose excreted in feces per sampling interval (%Fef)
Measured: Up to 13 days
Fecal recovery of total radioactivity as assessed by the cumulative percentage of radioactive dose excreted in feces per sampling interval (Cum %Fef)
Measured: Up to 13 days
Mass balance
Urine and fecal collection for Mass Balance Evaluation
Measured: Up to 13 days
Routes of elimination of [14C]-BGB-3111
Urine and fecal collection for Metabolite Profiling/Characterization
Measured: Up to 13 days
Secondary outcomes (4)
Characterize and identify metabolites of [14C]-BGB-3111
plasma, urine, and feces collection
Measured: Up to 13 days
plasma and urine concentrations of BGB-3111
plasma and urine collection
Measured: up to 13 days
Number of Participants experiencing Adverse events (AEs)
Measured: up to 13 days
Number of Participants experiencing abnormal clinical laboratory evaluations
Measured: up to 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start29 Mar 2017
- Primary completion18 Apr 2017
- Study completion18 Apr 2017
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
- Basic science
- 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
- Investigators
- William Novotony, MD, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163783
- Sponsor's protocol ID
- BGB-3111-105
- Status last verified
- Nov 2019
- First submitted
- 5 Nov 2019
- Last updated
- 15 Nov 2019
- 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 15 Nov 2019. 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-3111 Following Single Oral Dose Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04163783
- Acronym / sponsor ID
- BGB-3111-105
- Conditions
- Healthy Volunteers
- Keywords
- Phase 1, Pharmacokinetics, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 18 Apr 2017 (actual)
- Study completion
- 18 Apr 2017 (actual)
- First posted
- 15 Nov 2019 (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 an 8-hour fast from food on the pharmacokinetics of [14C]-BGB-3111.
Detailed description
This study will be an open-label, non-randomized study to evaluate the pharmacokinetics of [14C]-BGB-3111 when administered in healthy male subjects following at least an 8-hour fast from food (not including water).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: [14C]-BGB-3111, Drug: BGB-3111Subjects will be administered a single oral dose of 320 mg of [14C]-BGB-3111 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male between 18 and 65 years of age, inclusive, at Screening
- Body mass index between 18.0 and 35.0 kg/m2, inclusive, at Screening
- In good health, determined by no clinically significant findings from medical history,12-lead ECGs, or vital signs measurements
- Clinical laboratory evaluations
Key exclusion criteria (4 listed)
- Significant history or clinical manifestation of any metabolic, allergic, infectious, dermatological, hepatic, renal, hematological, pulmonary, metabolic, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator [or designee]) prior to Check-in
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) prior to Check-in
- History of stomach or intestinal surgery or resection that could alter absorption or excretion of orally administered drugs prior to Check-in except that appendectomy and hernia repair will be allowed if it was not associated with complications
- Abnormal liver function tests
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-311120-mg capsule containing ~200 μCi of [14C]-BGB-3111, | Drug | Arm A |
| BGB-3111Three 20-mg capsules of BGB-3111 and three 80-mg capsules of BGB-3111 | Drug | Arm A |
Primary outcome
Pharmacokinetic Parameter: Plasma concentration of [14C]-BGB-3111 as measured by area under concentration-time curve (AUC)
Time frame: Up to 13 days
Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) of [14C]-BGB-3111
Time frame: Up to 13 days
Pharmacokinetic Parameter: Time To Maximum Plasma Concentration (Tmax) of [14C]-BGB-3111
Time frame: Up to 13 days
Pharmacokinetic Parameter: apparent terminal elimination rate constant (λZ) of [14C]-BGB-3111
Time frame: Up to 13 days
Pharmacokinetic Parameter: Half-life Period of (T1/2) of [14C]-BGB-3111
Time frame: Up to 13 days
Pharmacokinetic Parameter: apparent systemic clearance (CL/F) of [14C]-BGB-3111
Time frame: Up to 13 days
Pharmacokinetic Parameter: apparent volume of distribution during the terminal phase (Vz/F) of [14C]-BGB-3111
Time frame: Up to 13 days
Blood and plasma concentrations of total radioactivity: Maximum Plasma Concentration (Cmax) of [14C]-BGB-3111
Time frame: Up to 13 days
Blood and plasma concentrations of total radioactivity: Time To Maximum Plasma Concentration (Tmax) of [14C]-BGB-3111
Time frame: Up to 13 days
Blood and plasma concentrations of total radioactivity of [14C]-BGB-3111 as measured by area under concentration-time curve (AUC)
Time frame: Up to 13 days
Blood and plasma concentrations of total radioactivity: apparent terminal elimination rate constant (λZ) of [14C]-BGB-3111
Time frame: Up to 13 days
Blood and plasma concentrations of total radioactivity: Half-life Period of (T1/2) of [14C]-BGB-3111
Time frame: Up to 13 days
Blood and plasma concentrations of total radioactivity: apparent systemic clearance (CL/F) of [14C]-BGB-3111
Time frame: Up to 13 days
Blood and plasma concentrations of total radioactivity: apparent volume of distribution during the terminal phase (Vz/F) of [14C]-BGB-3111
Time frame: Up to 13 days
Urinary recovery of total radioactivity of [14C]-BGB-3111 as assessed by the amount excreted in urine per sampling interval (Aeu)
Time frame: Up to 13 days
Urinary recovery of total radioactivity of [14C]-BGB-3111 as assessed by the cumulative amount excreted in urine per sampling interval (Cum Aeu)
Time frame: Up to 13 days
Urinary recovery of total radioactivity of [14C]-BGB-3111 as assessed by the percentage of drug or radioactive dose excreted in urine per sampling interval (%Feu)
Time frame: Up to 13 days
Urinary recovery of total radioactivity of [14C]-BGB-3111 as assessed by the cumulative percentage of drug or radioactive dose excreted in urine (Cum %Feu)
Time frame: Up to 13 days
Urinary recovery of total radioactivity as assessed by the renal clearance (CLR; for BGB-3111 only)
Time frame: Up to 13 days
Fecal recovery of total radioactivity as assessed by the amount of [14C]-BGB-3111 excreted in feces per sampling interval (Aef)
Time frame: Up to 13 days
Fecal recovery of total radioactivity as assessed by the cumulative amount of [14C]-BGB-3111 excreted in feces per sampling interval (Cum Aef)
Time frame: Up to 13 days
Fecal recovery of total radioactivity as assessed by the percentage of radioactive dose excreted in feces per sampling interval (%Fef)
Time frame: Up to 13 days
Fecal recovery of total radioactivity as assessed by the cumulative percentage of radioactive dose excreted in feces per sampling interval (Cum %Fef)
Time frame: Up to 13 days
Mass balance
Time frame: Up to 13 days
Urine and fecal collection for Mass Balance Evaluation
Routes of elimination of [14C]-BGB-3111
Time frame: Up to 13 days
Urine and fecal collection for Metabolite Profiling/Characterization
4 secondary outcomes
Characterize and identify metabolites of [14C]-BGB-3111
Time frame: Up to 13 days
plasma and urine concentrations of BGB-3111
Time frame: up to 13 days
Number of Participants experiencing Adverse events (AEs)
Time frame: up to 13 days
Number of Participants experiencing abnormal clinical laboratory evaluations
Time frame: up to 13 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 15 Nov 2019.
- 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.
William Novotony, 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 [14C]-BGB-3111 and BGB-3111 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 4 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 15 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?
Pharmacokinetic Parameter: Plasma concentration of [14C]-BGB-3111 as measured by area under concentration-time curve (AUC) (time frame: Up to 13 days). The study lists 25 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 15 Nov 2019.