Healthy VolunteerPhase 1NCT06640933
A Study to Find Out How Different Forms of BIIB091 is Processed in The Body With and Without Food in Healthy Participants
A Phase 1 study testing BIIB091 in people with Healthy Volunteer, run by Biogen at 2 sites in United States.
Trial summary
In this study, researchers will learn how the body processes new tablet forms of BIIB091 when taken with and without food. One new form of BIIB091 is an "extended release" tablet, also known as "ER." This form helps release BIIB091 slowly and consistently, helping to keep steady drug levels in the body for longer. 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?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Oct 2024to 7 Feb 2025
- 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
- Have a body mass index (BMI) of 18 to 32 kilograms per meter square (kg/m^2), inclusive, and a total body weight >50 kg, Screening and Day -1.
- Negative polymerase chain reaction (PCR) test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Check-in (Day -1).
- For Japanese participants:
- Have biological parents and grandparents of Japanese origin.
- If living outside of Japan for more than 5 years, must not have significantly modified diet since leaving Japan.
Who cannot join
- History of any clinically significant cardiac, endocrine,gastrointestinal (GI), hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease or other major disease, as determined by the Investigator.
- History of torsades de pointes or additional risk factors for torsades de pointes.
- Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia), as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -1.
- NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
PPD Clinical Research Unit
Austin, Texas, 78744
PPD Las Vegas Research Unit
Las Vegas, Nevada, 89113
About this study
Official title: A Phase 1, Randomized, Open-Label, Single-Dose, 6-Period Crossover Study to Evaluate the Pharmacokinetics of BIIB091 Formulations and the Effect of Food in Healthy Participants
In this study, researchers will learn how the body processes new tablet forms of BIIB091 when taken with and without food. One new form of BIIB091 is an "extended release" tablet, also known as "ER." This form helps release BIIB091 slowly and consistently, helping to keep steady drug levels in the body for longer. The other new form is a "gastro-retentive" tablet, also known as "GR." This form has a special coating that swells and allows BIIB091 to stay in the stomach longer. For both GR and ER tablets, there are also "slow" and "fast" forms that change how quickly BIIB091 is released into the body. But, eating food with these tablets may affect how much BIIB091 is in the body.
The main objective of this study is to learn how 2 new forms of BIIB091, which are released into the body at different rates, are processed in the body. Researchers also want to learn how these new forms compare to the "immediate release" tablet, also known as "IR". This form delivers BIIB091 immediately into the body.
Read more
The main question researchers want to answer in this study is:
- How does the body process different tablet forms of BIIB091 with or without food?
Researchers will also learn more about:
- How the body processes the 2 new tablet forms of BIIB091 with food compared to the IR tablet form with food
- How the body processes the ER tablet form of BIIB091 with food compared to without food
- Any medical problems the participants have during the study
- Any changes in the participants' overall health during the study
This study will be done as follows:
- Participants will be screened to check if they can join the study. The screening period will be up to 22 days, after which eligible participants will check into their study research center.
- Participants will be randomly assigned to 1 of 6 groups. In each group, the participants will take the below tablet forms, but in different orders:
- Immediate-Release (IR)
- Gastro-Retentive slow (GR-slow)
- Gastro-Retentive fast (GR-fast)
- Extended-Release slow (ER-slow)
- Extended-Release fast (ER-fast)
- ER-slow, without food
- Each period includes the participant taking a single dose of what they were assigned to on the first day. There will be 3 days of no dosing in each period. The participant will then move to the next tablet form assigned. This will continue until each participant has taken a single dose of each of the 6 tablet forms.
- Participants will remain at their study research center for 25 days for the treatment periods. Afterwards, there will be follow-up visit 11 to 14 days after each participant's last dose. Each participant will be in the study for up to 57 days.
Read the detailed description
The primary objective of this study is to characterize the pharmacokinetics (PK) of BIIB091 after a single oral dose of different BIIB091 formulations with or without food conditions in healthy participants.
The secondary objectives of this study are: to compare the exposure of BIIB091 after a single oral dose of 4 new BIIB091 formulations (GR-fast, GR-slow, ER-fast, ER-slow) with a moderate-fat meal versus a single oral dose of BIIB091 IR tablets with a moderate-fat meal in healthy participants; to compare the exposure of BIIB091 after a single oral dose of BIIB091 ER-slow formulation with a moderate-fat meal versus under fasting conditions in healthy participants; to evaluate the safety and tolerability of BIIB091 after a single oral dose of different BIIB091 formulations with or without food conditions in healthy participants.
- Conditions
- Healthy Volunteer
- Being tested
- BIIB091
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.
| Study group | Role | What they receive |
|---|---|---|
| BIIB091 IR | Experimental | Participants will receive BIIB091 IR tablets on Day 1 of its respective period, with food. Receives: Drug: BIIB091 |
| BIIB091 GR-slow | Experimental | Participants will receive BIIB091 GR-slow tablets on Day 1 of its respective period, with food. Receives: Drug: BIIB091 |
| BIIB091 GR-fast | Experimental | Participants will receive BIIB091 GR-fast tablets on Day 1 of its respective period, with food. Receives: Drug: BIIB091 |
| BIIB091 ER-slow | Experimental | Participants will receive BIIB091 ER-slow tablets on Day 1 of its respective period, with food. Receives: Drug: BIIB091 |
| BIIB091 ER-fast | Experimental | Participants will receive BIIB091 ER-fast tablets on Day 1 of its respective period, with food. Receives: Drug: BIIB091 |
| BIIB091 ER-slow Fasted | Experimental | Participants will receive BIIB091 ER-slow tablets on Day 1 of its respective period, without food. Receives: Drug: BIIB091 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB091
Measured: Predose and at multiple timepoints postdose (up to Day 4)
AUC from Time Zero to Infinity (AUCinf) of BIIB091
Measured: Predose and at multiple timepoints postdose (up to Day 4)
Maximum Observed Concentration (Cmax) of BIIB091
Measured: Predose and at multiple timepoints postdose (up to Day 4)
Time to Reach Cmax (Tmax) of BIIB091
Measured: Predose and at multiple timepoints postdose (up to Day 4)
Elimination Half-Life (t½) of BIIB091
Measured: Predose and at multiple timepoints postdose (up to Day 4)
Time of Last Measurable Concentration (Tlast) of BIIB091
Measured: Predose and at multiple timepoints postdose (up to Day 4)
Concentration of BIIB091 at 12 hours Postdose (C12h)
Measured: At multiple timepoints postdose (up to 12 hours)
Apparent Clearance (CL/F) of BIIB091
Measured: Predose and at multiple timepoints postdose (up to Day 4)
Apparent Volume of Distribution During the Terminal Elimination (VZ/F) of BIIB091
Measured: Predose and at multiple timepoints postdose (up to Day 4)
Secondary outcomes (8)
Geometric Mean Ratio (GMR) of AUClast of BIIB091
Measured: Predose and at multiple timepoints postdose (up to Day 4)
GMR of AUCinf of BIIB091
Measured: Predose and at multiple timepoints postdose (up to Day 4)
GMR of Cmax of BIIB091
Measured: Predose and at multiple timepoints postdose (up to Day 4)
GMR of C12h of BIIB091
Measured: At multiple timepoints postdose (up to 12 hours)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From Day 1 up to end of study follow-up (up to 35 days)
Number of Participants With Clinically Significant Vital Signs Abnormalities
Measured: From Day 1 up to end of study follow-up (up to 35 days)
Number of Participants With Electrocardiogram (ECG) Abnormalities
Measured: From Day 1 up to Day 4
Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Measured: At Days 4, 25 and during follow-up (up to 35 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start16 Oct 2024
- Primary completion7 Feb 2025
- Study completion7 Feb 2025
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT06640933
- Sponsor's protocol ID
- 257HV106
- Status last verified
- Feb 2025
- First submitted
- 10 Oct 2024
- Last updated
- 18 Feb 2025
- 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 https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Single-Dose, 6-Period Crossover Study to Evaluate the Pharmacokinetics of BIIB091 Formulations and the Effect of Food in Healthy Participants
- ClinicalTrials.gov ID
- NCT06640933
- Acronym / sponsor ID
- 257HV106
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 15 Oct 2024 (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.
In this study, researchers will learn how the body processes new tablet forms of BIIB091 when taken with and without food. One new form of BIIB091 is an "extended release" tablet, also known as "ER." This form helps release BIIB091 slowly and consistently, helping to keep steady drug levels in the body for longer. The other new form is a "gastro-retentive" tablet, also known as "GR." This form has a special coating that swells and allows BIIB091 to stay in the stomach longer. For both GR and ER tablets, there are also "slow" and "fast" forms that change how quickly BIIB091 is released into the body. But, eating food with these tablets may affect how much BIIB091 is in the body.
The main objective of this study is to learn how 2 new forms of BIIB091, which are released into the body at different rates, are processed in the body. Researchers also want to learn how these new forms compare to the "immediate release" tablet, also known as "IR". This form delivers BIIB091 immediately into the body.
The main question researchers want to answer in this study is:
- How does the body process different tablet forms of BIIB091 with or without food?
Researchers will also learn more about:
- How the body processes the 2 new tablet forms of BIIB091 with food compared to the IR tablet form with food
- How the body processes the ER tablet form of BIIB091 with food compared to without food
- Any medical problems the participants have during the study
- Any changes in the participants' overall health during the study
This study will be done as follows:
- Participants will be screened to check if they can join the study. The screening period will be up to 22 days, after which eligible participants will check into their study research center.
- Participants will be randomly assigned to 1 of 6 groups. In each group, the participants will take the below tablet forms, but in different orders:
- Immediate-Release (IR)
- Gastro-Retentive slow (GR-slow)
- Gastro-Retentive fast (GR-fast)
- Extended-Release slow (ER-slow)
- Extended-Release fast (ER-fast)
- ER-slow, without food
- Each period includes the participant taking a single dose of what they were assigned to on the first day. There will be 3 days of no dosing in each period. The participant will then move to the next tablet form assigned. This will continue until each participant has taken a single dose of each of the 6 tablet forms.
- Participants will remain at their study research center for 25 days for the treatment periods. Afterwards, there will be follow-up visit 11 to 14 days after each participant's last dose. Each participant will be in the study for up to 57 days.
Detailed description
The primary objective of this study is to characterize the pharmacokinetics (PK) of BIIB091 after a single oral dose of different BIIB091 formulations with or without food conditions in healthy participants.
The secondary objectives of this study are: to compare the exposure of BIIB091 after a single oral dose of 4 new BIIB091 formulations (GR-fast, GR-slow, ER-fast, ER-slow) with a moderate-fat meal versus a single oral dose of BIIB091 IR tablets with a moderate-fat meal in healthy participants; to compare the exposure of BIIB091 after a single oral dose of BIIB091 ER-slow formulation with a moderate-fat meal versus under fasting conditions in healthy participants; to evaluate the safety and tolerability of BIIB091 after a single oral dose of different BIIB091 formulations with or without food conditions in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BIIB091 IR | Experimental | Drug: BIIB091Participants will receive BIIB091 IR tablets on Day 1 of its respective period, with food. |
| BIIB091 GR-slow | Experimental | Drug: BIIB091Participants will receive BIIB091 GR-slow tablets on Day 1 of its respective period, with food. |
| BIIB091 GR-fast | Experimental | Drug: BIIB091Participants will receive BIIB091 GR-fast tablets on Day 1 of its respective period, with food. |
| BIIB091 ER-slow | Experimental | Drug: BIIB091Participants will receive BIIB091 ER-slow tablets on Day 1 of its respective period, with food. |
| BIIB091 ER-fast | Experimental | Drug: BIIB091Participants will receive BIIB091 ER-fast tablets on Day 1 of its respective period, with food. |
| BIIB091 ER-slow Fasted | Experimental | Drug: BIIB091Participants will receive BIIB091 ER-slow tablets on Day 1 of its respective period, without food. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Have a body mass index (BMI) of 18 to 32 kilograms per meter square (kg/m^2), inclusive, and a total body weight >50 kg, Screening and Day -1.
- Negative polymerase chain reaction (PCR) test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Check-in (Day -1).
- For Japanese participants:
Key exclusion criteria (4 listed)
- History of any clinically significant cardiac, endocrine,gastrointestinal (GI), hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease or other major disease, as determined by the Investigator.
- History of torsades de pointes or additional risk factors for torsades de pointes.
- Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia), as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -1.
- NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
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 | BIIB091 ER-fast, BIIB091 ER-slow, BIIB091 ER-slow Fasted, BIIB091 GR-fast, BIIB091 GR-slow, BIIB091 IR |
Primary outcome
Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB091
Time frame: Predose and at multiple timepoints postdose (up to Day 4)
AUC from Time Zero to Infinity (AUCinf) of BIIB091
Time frame: Predose and at multiple timepoints postdose (up to Day 4)
Maximum Observed Concentration (Cmax) of BIIB091
Time frame: Predose and at multiple timepoints postdose (up to Day 4)
Time to Reach Cmax (Tmax) of BIIB091
Time frame: Predose and at multiple timepoints postdose (up to Day 4)
Elimination Half-Life (t½) of BIIB091
Time frame: Predose and at multiple timepoints postdose (up to Day 4)
Time of Last Measurable Concentration (Tlast) of BIIB091
Time frame: Predose and at multiple timepoints postdose (up to Day 4)
Concentration of BIIB091 at 12 hours Postdose (C12h)
Time frame: At multiple timepoints postdose (up to 12 hours)
Apparent Clearance (CL/F) of BIIB091
Time frame: Predose and at multiple timepoints postdose (up to Day 4)
Apparent Volume of Distribution During the Terminal Elimination (VZ/F) of BIIB091
Time frame: Predose and at multiple timepoints postdose (up to Day 4)
8 secondary outcomes
Geometric Mean Ratio (GMR) of AUClast of BIIB091
Time frame: Predose and at multiple timepoints postdose (up to Day 4)
GMR of AUCinf of BIIB091
Time frame: Predose and at multiple timepoints postdose (up to Day 4)
GMR of Cmax of BIIB091
Time frame: Predose and at multiple timepoints postdose (up to Day 4)
GMR of C12h of BIIB091
Time frame: At multiple timepoints postdose (up to 12 hours)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to end of study follow-up (up to 35 days)
Number of Participants With Clinically Significant Vital Signs Abnormalities
Time frame: From Day 1 up to end of study follow-up (up to 35 days)
Number of Participants With Electrocardiogram (ECG) Abnormalities
Time frame: From Day 1 up to Day 4
Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Time frame: At Days 4, 25 and during follow-up (up to 35 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 18 Feb 2025.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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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
2 sites 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 2 sites 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 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB091 (time frame: Predose and at multiple timepoints postdose (up to Day 4)). The study lists 9 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 18 Feb 2025.