Healthy ParticipantsPhase 1NCT03596632
Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers
A Phase 1 study testing Fenebrutinib in people with Healthy Participants, run by Hoffmann-La Roche at 1 site in United States.
Trial summary
The purpose of this study is to determine the excretion kinetics and mass balance of fenebrutinib in healthy male 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 Participants
- What is being tested?
- Fenebrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2018to 23 Aug 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
- Healthy male subjects, between 18 and 60 years of age, inclusive
- Within body mass index range 18 to 32 kg/m2, inclusive
- In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs, and physical examination
- For males who are sterile: agreement to use a condom with a fertile or pregnant female partner from Day -1 until 90 days following Study Completion; for males who are fertile: agreement to use a condom with spermicide with a fertile or pregnant female partner from Day -1 until 90 days following Study Completion
Who cannot join
- History or symptoms of any significant disease
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
- History of stomach or intestinal surgery or resection, except appendectomy, hernia repair, and cholecystectomy
- History of malignancy, except for non-melanoma skin carcinoma with 3-year disease-free follow-up
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to Day -1
- Exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Day -1
- Participation in a radiolabeled drug study in which exposures are known to the Investigator within 4 months prior to Day -1, or participation in a radiolabeled drug study in which exposures are not known to the Investigator within 6 months prior to Day -1. The total 12-month exposure from this study and a maximum of 2 other studies must be within the Code of Federal Regulations (CFR) recommended levels considered state (per 21 CFR 361.1), e.g. less than 5,000 mrem whole body annual exposure
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 Open-label Study Investigating the Excretion Balance, Pharmacokinetics, and Metabolism of a Single Oral Dose of [14C/12C]-Labeled Fenebrutinib in Healthy Volunteers
The purpose of this study is to determine the excretion kinetics and mass balance of fenebrutinib in healthy male subjects.
- Conditions
- Healthy Participants
- Being tested
- Fenebrutinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenebrutinibDrug
Also called RO7010939
200-mg (100 µCi) oral solution 14C/12C]-fenebrutinib
| Study group | Role | What they receive |
|---|---|---|
| Single Oral Solution Dose | Experimental | Single 200-mg (approximately 100-µCi) oral solution dose of [14C/12C]-fenebrutinib under fasted conditions. Receives: Drug: Fenebrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Percentage of the Total Radioactive Dose Administered Excreted from Urine and Feces"; TimeFrame: "Day 1 to end of study (approximately 35 days post-dose)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any AE that can be fatal, life threatening, prolongs inpatient hospitalization, significant disability, congenital anamoly, is a significant medical event in the Investigator's judgment.
Measured: Screening to end of study (approximately 35 days post-dose)
Secondary outcomes (10)
Maximum Observed Concentration (Cmax) of Fenebrutinib and its Metabolites
Measured: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Time to Observed Maximum Concentration (Tmax) of Fenebrutinib and its Metabolites
Measured: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t) of Fenebrutinib and its Metabolites
Measured: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Area under the Concentration-Time Curve Extrapolated to Infinity (AUC0-infinity) of Fenebrutinib and its Metabolites
Measured: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Cumulative Percent of Total Radioactivity Excreted in Urine Over the Sampling Interval (Total % Feu)
Measured: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Cumulative Percent of Total Radioactivity Excreted in Feces Over the Sampling Interval (Total % Fef)
Measured: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Number of Participants With Clinical Significant Changes in Vital Signs
Vital signs incudes oral temperature, respiratory rate, supine blood pressure and pulse.
Measured: Screening up to Day 31
Number of Participants With Clinical Significant Changes in Physical Examination Findings
Physical examination will consist of an assessment of general appearance, skin, thorax/lungs, abdomen, lymph nodes, head, ears, eyes, nose, throat, neck (including thyroid); and cardiovascular, musculoskeletal, and neurological systems.
Measured: Day -1, 28
Number of Participants With Clinical Significant Changes in Clinical Laboratory Results
Laboratory analysis include chemistry panel, complete blood count and urinalysis.
Measured: Screnning, Day -1, 2, 4, 28
Number of Participants With Clinical Significant Changes in Electrocardiograms (ECGs)
Measured: Screening, Day-1, 1 (Pre-dose; 1, 3 hours [h] post-dose), 28, 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start27 Jul 2018
- Primary completion23 Aug 2018
- Study completion23 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596632
- Sponsor's protocol ID
- GP40605
- Status last verified
- Dec 2018
- First submitted
- 13 Jul 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label Study Investigating the Excretion Balance, Pharmacokinetics, and Metabolism of a Single Oral Dose of [14C/12C]-Labeled Fenebrutinib in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03596632
- Acronym / sponsor ID
- GP40605
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2018 (actual)
- Primary completion
- 23 Aug 2018 (actual)
- Study completion
- 23 Aug 2018 (actual)
- First posted
- 24 Jul 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.
The purpose of this study is to determine the excretion kinetics and mass balance of fenebrutinib in healthy male subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Oral Solution Dose | Experimental | Drug: FenebrutinibSingle 200-mg (approximately 100-µCi) oral solution dose of [14C/12C]-fenebrutinib under fasted conditions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects, between 18 and 60 years of age, inclusive
- Within body mass index range 18 to 32 kg/m2, inclusive
- In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs, and physical examination
- For males who are sterile: agreement to use a condom with a fertile or pregnant female partner from Day -1 until 90 days following Study Completion; for males who are fertile: agreement to use a condom with spermicide with a fertile or pregnant female partner from Day -1 until 90 days following Study Completion
Key exclusion criteria (7 listed)
- History or symptoms of any significant disease
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
- History of stomach or intestinal surgery or resection, except appendectomy, hernia repair, and cholecystectomy
- History of malignancy, except for non-melanoma skin carcinoma with 3-year disease-free follow-up
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to Day -1
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 |
|---|---|---|
| FenebrutinibAlso: RO7010939200-mg (100 µCi) oral solution 14C/12C]-fenebrutinib | Drug | Single Oral Solution Dose |
Primary outcome
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Percentage of the Total Radioactive Dose Administered Excreted from Urine and Feces"; TimeFrame: "Day 1 to end of study (approximately 35 days post-dose)
Time frame: Screening to end of study (approximately 35 days post-dose)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any AE that can be fatal, life threatening, prolongs inpatient hospitalization, significant disability, congenital anamoly, is a significant medical event in the Investigator's judgment.
10 secondary outcomes
Maximum Observed Concentration (Cmax) of Fenebrutinib and its Metabolites
Time frame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Time to Observed Maximum Concentration (Tmax) of Fenebrutinib and its Metabolites
Time frame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t) of Fenebrutinib and its Metabolites
Time frame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Area under the Concentration-Time Curve Extrapolated to Infinity (AUC0-infinity) of Fenebrutinib and its Metabolites
Time frame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Cumulative Percent of Total Radioactivity Excreted in Urine Over the Sampling Interval (Total % Feu)
Time frame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Cumulative Percent of Total Radioactivity Excreted in Feces Over the Sampling Interval (Total % Fef)
Time frame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Number of Participants With Clinical Significant Changes in Vital Signs
Time frame: Screening up to Day 31
Number of Participants With Clinical Significant Changes in Physical Examination Findings
Time frame: Day -1, 28
Number of Participants With Clinical Significant Changes in Clinical Laboratory Results
Time frame: Screnning, Day -1, 2, 4, 28
Number of Participants With Clinical Significant Changes in Electrocardiograms (ECGs)
Time frame: Screening, Day-1, 1 (Pre-dose; 1, 3 hours [h] post-dose), 28, 31
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 6 Dec 2018.
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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.
Clinical Trials study director
Hoffmann-La Roche
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 Fenebrutinib in people with Healthy Participants, run by Hoffmann-La Roche 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 7 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 6 Dec 2018. 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?
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Percentage of the Total Radioactive Dose Administered Excreted from Urine and Feces"; TimeFrame: "Day 1 to end of study (approximately 35 days post-dose) (time frame: Screening to end of study (approximately 35 days post-dose)). 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 6 Dec 2018.