Healthy VolunteersPhase 1NCT05152485
A Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB104 and Assess the Effect of Food on the Pharmacokinetics of BIIB104 Following Administration of a Single, Fixed, Oral Dose of BIIB104 in Healthy Participants
A Phase 1 study testing BIIB104 Reference Formulation and BIIB104 Test Formulation in people with Healthy Volunteers, run by Biogen at 1 site in United States.
Trial summary
The primary objectives of this study are to evaluate the relative bioavailability of the BIIB104 test formulation compared with the reference formulation in healthy Caucasian male adult participants in the fasted state and to assess the impact of food on BIIB104 pharmacokinetic (PK) parameters for the test formulation… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BIIB104 Reference Formulation and BIIB104 Test Formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2021to 31 Jan 2022
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has a body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m^2), inclusive and a total body weight >50 kilograms [110 pound (lb)].
Who cannot join
- Participates in other studies involving treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to randomization and/or during study participation.
- Previously participated in this study or previous studies with BIIB104.
- 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, Open-Label, Parallel-Arm Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB104 and Assess the Effect of Food on the Pharmacokinetics of BIIB104 Following Administration of a Single, Fixed, Oral Dose of BIIB104 in Healthy Participants
The primary objectives of this study are to evaluate the relative bioavailability of the BIIB104 test formulation compared with the reference formulation in healthy Caucasian male adult participants in the fasted state and to assess the impact of food on BIIB104 pharmacokinetic (PK) parameters for the test formulation in healthy Caucasian male adult participants.
The secondary objective of the study is to assess the safety and tolerability of BIIB104 0.5 milligrams (mg) test formulation in the fasted and fed states following single-dose administration.
- Conditions
- Healthy Volunteers
- Being tested
- BIIB104 Reference Formulation, BIIB104 Test Formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB104 Reference FormulationDrug
Administered as specified in the treatment arm
BIIB104 Test FormulationDrug
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| BIIB104 0.5 mg Reference Formulation (Fasted State) | Active comparator | Participants will receive BIIB104 0.5 mg, immediate-release liquid-filled hard-shell capsule, orally, on Day 1 in the fasted state. Receives: Drug: BIIB104 Reference Formulation |
| BIIB104 0.5 mg Test Formulation (Fasted State) | Experimental | Participants will receive BIIB104 0.5 mg, immediate-release softgel capsule, orally, on Day 1 in the fasted state. Receives: Drug: BIIB104 Test Formulation |
| BIIB104 0.5 mg Test Formulation (Fed State) | Experimental | Participants will receive BIIB104 0.5 mg, immediate-release softgel capsule, orally, on Day 1 in the fed state. Receives: Drug: BIIB104 Test Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve from Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB104
Measured: Up to Day 6
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUCinf) of BIIB104
Measured: Up to Day 6
Maximum Observed Plasma Concentration (Cmax) of BIIB104
Measured: Up to Day 6
Time to Reach Maximum Observed Plasma Concentration (Tmax) for BIIB104
Measured: Up to Day 6
Secondary outcomes (4)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs that start or worsen after receiving the study drug. 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); 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: From Day 1 up to end of study (up to Day 16)
Number of Participants with Clinically Significant Abnormalities in Clinical Laboratory Parameters
Measured: From Day 1 up to end of study (up to Day 16)
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Measured: From Day 1 up to end of study (up to Day 16)
Number of Participants with Clinically Significant Abnormalities in Physical Examination Parameters
Measured: From Day 1 up to end of study (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 Dec 2021
- Study start15 Dec 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
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 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT05152485
- Sponsor's protocol ID
- 263HV109
- Status last verified
- Apr 2023
- First submitted
- 8 Dec 2021
- Last updated
- 18 Apr 2023
- 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 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Parallel-Arm Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB104 and Assess the Effect of Food on the Pharmacokinetics of BIIB104 Following Administration of a Single, Fixed, Oral Dose of BIIB104 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05152485
- Acronym / sponsor ID
- 263HV109
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 9 Dec 2021 (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 primary objectives of this study are to evaluate the relative bioavailability of the BIIB104 test formulation compared with the reference formulation in healthy Caucasian male adult participants in the fasted state and to assess the impact of food on BIIB104 pharmacokinetic (PK) parameters for the test formulation in healthy Caucasian male adult participants.
The secondary objective of the study is to assess the safety and tolerability of BIIB104 0.5 milligrams (mg) test formulation in the fasted and fed states following single-dose administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIIB104 0.5 mg Reference Formulation (Fasted State) | Active comparator | Drug: BIIB104 Reference FormulationParticipants will receive BIIB104 0.5 mg, immediate-release liquid-filled hard-shell capsule, orally, on Day 1 in the fasted state. |
| BIIB104 0.5 mg Test Formulation (Fasted State) | Experimental | Drug: BIIB104 Test FormulationParticipants will receive BIIB104 0.5 mg, immediate-release softgel capsule, orally, on Day 1 in the fasted state. |
| BIIB104 0.5 mg Test Formulation (Fed State) | Experimental | Drug: BIIB104 Test FormulationParticipants will receive BIIB104 0.5 mg, immediate-release softgel capsule, orally, on Day 1 in the fed state. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Has a body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m^2), inclusive and a total body weight >50 kilograms [110 pound (lb)].
Key exclusion criteria (3 listed)
- Participates in other studies involving treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to randomization and/or during study participation.
- Previously participated in this study or previous studies with BIIB104.
- 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 |
|---|---|---|
| BIIB104 Reference FormulationAdministered as specified in the treatment arm | Drug | BIIB104 0.5 mg Reference Formulation (Fasted State) |
| BIIB104 Test FormulationAdministered as specified in the treatment arm | Drug | BIIB104 0.5 mg Test Formulation (Fasted State), BIIB104 0.5 mg Test Formulation (Fed State) |
Primary outcome
Area Under the Plasma Concentration-Time Curve from Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB104
Time frame: Up to Day 6
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUCinf) of BIIB104
Time frame: Up to Day 6
Maximum Observed Plasma Concentration (Cmax) of BIIB104
Time frame: Up to Day 6
Time to Reach Maximum Observed Plasma Concentration (Tmax) for BIIB104
Time frame: Up to Day 6
4 secondary outcomes
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to end of study (up to Day 16)
Number of Participants with Clinically Significant Abnormalities in Clinical Laboratory Parameters
Time frame: From Day 1 up to end of study (up to Day 16)
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Time frame: From Day 1 up to end of study (up to Day 16)
Number of Participants with Clinically Significant Abnormalities in Physical Examination Parameters
Time frame: From Day 1 up to end of study (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 18 Apr 2023.
- 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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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 BIIB104 Reference Formulation and BIIB104 Test Formulation in people with Healthy Volunteers, 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 1 inclusion and 3 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 Apr 2023. 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?
Area Under the Plasma Concentration-Time Curve from Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB104 (time frame: Up to Day 6). The study lists 4 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 Apr 2023.