Healthy VolunteerPhase 1NCT03943056
A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants
A Phase 1 study testing BIIB091 in people with Healthy Volunteer, run by Biogen at 1 site in United States.
Trial summary
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of BIIB091 in healthy participants.This study will also determine the effect of food on the single oral dose pharmacokinetic (PK). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- BIIB091
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2019to 10 Jan 2020
- 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
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with applicable participant privacy regulations.
- Have a body mass index between 18 and 30 kg/m2, inclusive.
- All male participants must practice highly effective methods of contraception and not donate sperm during the study and for at least 1 spermatogenic cycle (90 days) after administration of last dose of study treatment.
- All female participants of childbearing potential must practice highly effective methods of contraception and not donate eggs during the study and for at least 90 days after their last dose of study treatment.
- Must be in good health as by the Investigator, based on medical history and screening evaluations.
Who cannot join
- History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic,hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- History of severe allergic or anaphylactic reactions, or of any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by any component of the study treatment.
- History of, or ongoing, malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 12 months prior to Check-in).
- Current enrollment or plan to enroll in any other drug, biological, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days prior to Check-in, or 5 half-lives of the drug or therapy, whichever is longer.
- Breastfeeding, pregnant, or planning to become pregnant during study participation.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of BIIB091 in healthy participants.This study will also determine the effect of food on the single oral dose pharmacokinetic (PK).
Read the detailed description
Initial protocol recruitment and follow up was completed by 10 Jan 2020 with an optional cohort intended for completion by April 2020. Subsequently, a decision was made not to progress this optional cohort in light of COVID-19 which has resulted in a delay in reporting the actual completion date.
- Conditions
- Healthy Volunteer
- Being tested
- BIIB091, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB091Drug
Administered as specified in the treatment arm.
PlaceboDrug
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose (SAD): Cohort 1A | Experimental | Participants will receive dose level 1 of BIIB091 or placebo, orally, while fasting on Day 1. Receives: Drug: BIIB091; Drug: Placebo |
| (SAD): Cohort 2A | Experimental | Participants will receive dose level 2 of BIIB091 or placebo, orally, while fasting on Day 1. Receives: Drug: BIIB091; Drug: Placebo |
| (SAD): Cohort 3A | Experimental | Participants will receive dose level 3 of BIIB091 or placebo, orally, while fasting on Day 1, then again following a 7 day washout and high-fat meal. Receives: Drug: BIIB091; Drug: Placebo |
| (SAD): Cohort 4A | Experimental | Participants will receive dose level 4 of BIIB091 or placebo, orally, while fasting on Day 1. Receives: Drug: BIIB091; Drug: Placebo |
| (SAD): Cohort 5A | Experimental | Participants will receive dose level 5 of BIIB091 or placebo, orally, while fasting on Day 1. Receives: Drug: BIIB091; Drug: Placebo |
| Multiple Ascending Dose (MAD): Cohort 1B | Experimental | Participants will receive dose level 1 of BIIB091 or placebo, orally, twice daily (BID) for 13 days, and a single dose on Day 14. Receives: Drug: BIIB091; Drug: Placebo |
| (MAD): Cohort 2B | Experimental | Participants will receive dose level 2 of BIIB091 or placebo, orally, BID for 13 days, and a single dose on Day 14. Receives: Drug: BIIB091; Drug: Placebo |
| (MAD): Cohort 3B | Experimental | Participants will receive dose level 3 of BIIB091 or placebo, orally, BID for 13 days, and a single dose on Day 14. Receives: Drug: BIIB091; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death, in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event), however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.
Measured: Baseline up to Day 9 for SAD Cohorts; Baseline up to Day 24 for MAD Cohorts
Secondary outcomes (13)
Area Under the Curve from Time 0 to the Time of the Last Measurable Concentration (AUClast)
Measured: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)
Measured: Baseline and multiple timepoints up to Day 3
Maximum Observed Concentration (Cmax)
Measured: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 14 for MAD Cohorts
Time to Reach Maximum Observed Concentration (Tmax)
Measured: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 14 for MAD Cohorts
Elimination Half-Life (t½)
Measured: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts
Apparent Total Body Clearance (CL/F)
Measured: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)
Measured: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts
Amount of BIIB091 Excreted in Urine per Sampling Interval (Aeu)
Measured: Baseline and multiple timepoints up to Day 3
Percentage of BIIB091 Excreted in Urine per Sampling Interval (%Feu)
Measured: Baseline and multiple timepoints up to Day 3
Renal clearance (CLr)
Measured: Baseline and multiple timepoints up to Day 3
Area Under the Concentration-Time Curve Within a Dosing Interval (AUCtau)
Measured: Baseline and multiple timepoints up to Day 16
Accumulation Ratio (R)
Measured: Baseline and multiple timepoints up to Day 16
Trough concentration (Ctrough)
Measured: Baseline and multiple timepoints up to Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start13 May 2019
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by BiogenThe 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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943056
- Sponsor's protocol ID
- 257HV101
- Status last verified
- Mar 2021
- First submitted
- 7 May 2019
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT03943056
- Acronym / sponsor ID
- 257HV101
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 13 May 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 9 May 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.
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of BIIB091 in healthy participants.This study will also determine the effect of food on the single oral dose pharmacokinetic (PK).
Detailed description
Initial protocol recruitment and follow up was completed by 10 Jan 2020 with an optional cohort intended for completion by April 2020. Subsequently, a decision was made not to progress this optional cohort in light of COVID-19 which has resulted in a delay in reporting the actual completion date.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (SAD): Cohort 1A | Experimental | Drug: BIIB091, Drug: PlaceboParticipants will receive dose level 1 of BIIB091 or placebo, orally, while fasting on Day 1. |
| (SAD): Cohort 2A | Experimental | Drug: BIIB091, Drug: PlaceboParticipants will receive dose level 2 of BIIB091 or placebo, orally, while fasting on Day 1. |
| (SAD): Cohort 3A | Experimental | Drug: BIIB091, Drug: PlaceboParticipants will receive dose level 3 of BIIB091 or placebo, orally, while fasting on Day 1, then again following a 7 day washout and high-fat meal. |
| (SAD): Cohort 4A | Experimental | Drug: BIIB091, Drug: PlaceboParticipants will receive dose level 4 of BIIB091 or placebo, orally, while fasting on Day 1. |
| (SAD): Cohort 5A | Experimental | Drug: BIIB091, Drug: PlaceboParticipants will receive dose level 5 of BIIB091 or placebo, orally, while fasting on Day 1. |
| Multiple Ascending Dose (MAD): Cohort 1B | Experimental | Drug: BIIB091, Drug: PlaceboParticipants will receive dose level 1 of BIIB091 or placebo, orally, twice daily (BID) for 13 days, and a single dose on Day 14. |
| (MAD): Cohort 2B | Experimental | Drug: BIIB091, Drug: PlaceboParticipants will receive dose level 2 of BIIB091 or placebo, orally, BID for 13 days, and a single dose on Day 14. |
| (MAD): Cohort 3B | Experimental | Drug: BIIB091, Drug: PlaceboParticipants will receive dose level 3 of BIIB091 or placebo, orally, BID for 13 days, and a single dose on Day 14. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with applicable participant privacy regulations.
- Have a body mass index between 18 and 30 kg/m2, inclusive.
- All male participants must practice highly effective methods of contraception and not donate sperm during the study and for at least 1 spermatogenic cycle (90 days) after administration of last dose of study treatment.
- All female participants of childbearing potential must practice highly effective methods of contraception and not donate eggs during the study and for at least 90 days after their last dose of study treatment.
- Must be in good health as by the Investigator, based on medical history and screening evaluations.
Key exclusion criteria (6 listed)
- History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic,hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- History of severe allergic or anaphylactic reactions, or of any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by any component of the study treatment.
- History of, or ongoing, malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 12 months prior to Check-in).
- Current enrollment or plan to enroll in any other drug, biological, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days prior to Check-in, or 5 half-lives of the drug or therapy, whichever is longer.
- Breastfeeding, pregnant, or planning to become pregnant during study participation.
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 |
|---|---|---|
| BIIB091Administered as specified in the treatment arm. | Drug | (MAD): Cohort 2B, (MAD): Cohort 3B, (SAD): Cohort 2A, (SAD): Cohort 3A, (SAD): Cohort 4A, (SAD): Cohort 5A, Multiple Ascending Dose (MAD): Cohort 1B, Single Ascending Dose (SAD): Cohort 1A |
| PlaceboAdministered as specified in the treatment arm. | Drug | (MAD): Cohort 2B, (MAD): Cohort 3B, (SAD): Cohort 2A, (SAD): Cohort 3A, (SAD): Cohort 4A, (SAD): Cohort 5A, Multiple Ascending Dose (MAD): Cohort 1B, Single Ascending Dose (SAD): Cohort 1A |
Primary outcome
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 9 for SAD Cohorts; Baseline up to Day 24 for MAD Cohorts
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death, in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event), however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.
13 secondary outcomes
Area Under the Curve from Time 0 to the Time of the Last Measurable Concentration (AUClast)
Time frame: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)
Time frame: Baseline and multiple timepoints up to Day 3
Maximum Observed Concentration (Cmax)
Time frame: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 14 for MAD Cohorts
Time to Reach Maximum Observed Concentration (Tmax)
Time frame: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 14 for MAD Cohorts
Elimination Half-Life (t½)
Time frame: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts
Apparent Total Body Clearance (CL/F)
Time frame: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)
Time frame: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts
Amount of BIIB091 Excreted in Urine per Sampling Interval (Aeu)
Time frame: Baseline and multiple timepoints up to Day 3
Percentage of BIIB091 Excreted in Urine per Sampling Interval (%Feu)
Time frame: Baseline and multiple timepoints up to Day 3
Renal clearance (CLr)
Time frame: Baseline and multiple timepoints up to Day 3
Area Under the Concentration-Time Curve Within a Dosing Interval (AUCtau)
Time frame: Baseline and multiple timepoints up to Day 16
Accumulation Ratio (R)
Time frame: Baseline and multiple timepoints up to Day 16
Trough concentration (Ctrough)
Time frame: Baseline and multiple timepoints up to Day 16
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 22 Mar 2021.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
Related trials for Healthy Volunteer
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
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Medical Director study director
Biogen
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 BIIB091 in people with Healthy Volunteer, run by Biogen 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 6 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 22 Mar 2021. 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?
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to Day 9 for SAD Cohorts; Baseline up to Day 24 for MAD Cohorts). 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 22 Mar 2021.