Healthy VolunteersPhase 1NCT05005338
A Study to Determine the Absolute Bioavailability of BIIB122/DNL151 in Healthy Subjects
A Phase 1 study testing BIIB122 (DNL151) and [14C] BIIB122 ([14C] DNL151) in people with Healthy Volunteers, run by Biogen at 1 site in United States.
Trial summary
This is a single center, non-randomized, open label Phase 1 study to determine the PK and absolute bioavailability of BIIB122 (DNL151) in 2 conditions: following a single, oral dose of BIIB122 (DNL151) and following consecutive days of oral dosing, approximating steady state. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BIIB122 (DNL151) and [14C] BIIB122 ([14C] DNL151)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2021to 23 Sep 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women of non-childbearing potential and men either with a vasectomy, using contraception, or having sex with a woman of non-childbearing potential
- Body mass index (BMI) ≥ 18 kg/m2 and ≤ 32 kg/m2
- Considered to be in good health
- Nonsmoker
Who cannot join
- History or presence of any condition or prior surgery that, in the opinion of the investigator, poses a significant risk to subject safety and/or achievement of study objectives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Phase 1 Study to Determine the Absolute Bioavailability of Single and Repeated Daily Oral Administration of BIIB122 (DNL151) Utilizing a Microtracer Dose of Intravenously Administered [14C] BIIB122 ([14C] DNL151) to Healthy Subjects
This is a single center, non-randomized, open label Phase 1 study to determine the PK and absolute bioavailability of BIIB122 (DNL151) in 2 conditions: following a single, oral dose of BIIB122 (DNL151) and following consecutive days of oral dosing, approximating steady state.
Read the detailed description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
- Conditions
- Healthy Volunteers
- Being tested
- BIIB122 (DNL151), [14C] BIIB122 ([14C] DNL151)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB122 (DNL151)Drug
Oral doses
[14C] BIIB122 ([14C] DNL151)Drug
Intravenous doses
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Not described Receives: Drug: BIIB122 (DNL151); Drug: [14C] BIIB122 ([14C] DNL151) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK Parameter: The first time to maximum observed concentration (Tmax) of BIIB122 (DNL151) in plasma following oral administration
Measured: 1 day
PK Parameter: Maximum observed concentration (Cmax) of BIIB122 (DNL151) in plasma following oral administration
Measured: 1 day
PK Parameter: Area under the concentration-time curve (AUC) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151 in plasma following oral and intravenous administration
Measured: 1 day
PK Parameter: Time from baseline at which half of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151 has been eliminated (t1/2) in plasma after oral and intravenous administration
Measured: 1 day
PK Parameter: Clearance (CL/F and CL) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration
Measured: 1 day
PK Parameter: Volume of distribution (Vd/F and Vd) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration
Measured: 1 day
PK Parameter: Absolute bioavailability (F) of BIIB122 (DNL151) after oral administration
Measured: 1 day
PK Parameter: The first time to maximum observed concentration (Tmax) of BIIB122 (DNL151) in plasma following oral administration
Measured: 21 days
PK Parameter: Maximum observed concentration (Cmax) of BIIB122 (DNL151) in plasma following oral administration
Measured: 21 days
PK Parameter: Concentration of BIIB122 (DNL151) in plasma at the end of dosing interval
Measured: 21 days
PK Parameter: Area under the concentration-time curve of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) in plasma following oral and intravenous administration
Measured: 21 days
PK Parameter: Time from baseline at which half of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) has been eliminated (t1/2) in plasma after oral and intravenous administration
Measured: 21 days
PK Parameter: Volume of distribution (Vd/F and Vd) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration
Measured: 21 days
PK Parameter: Clearance (CL/F and CL) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration
Measured: 21 days
PK Parameter: Absolute bioavailability (F) of BIIB122 (DNL151) after oral administration
Measured: 21 days
Secondary outcomes (2)
Incidence of adverse events (AEs)
Measured: 31 days
Incidence of serious adverse events (SAEs)
Measured: 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start28 Jul 2021
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Denali Therapeutics Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Denali Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005338
- Sponsor's protocol ID
- 283HV103
- Status last verified
- Nov 2021
- First submitted
- 27 Jul 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase 1 Study to Determine the Absolute Bioavailability of Single and Repeated Daily Oral Administration of BIIB122 (DNL151) Utilizing a Microtracer Dose of Intravenously Administered [14C] BIIB122 ([14C] DNL151) to Healthy Subjects
- ClinicalTrials.gov ID
- NCT05005338
- Acronym / sponsor ID
- 283HV103
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Collaborators
- Denali Therapeutics Inc.
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 13 Aug 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.
This is a single center, non-randomized, open label Phase 1 study to determine the PK and absolute bioavailability of BIIB122 (DNL151) in 2 conditions: following a single, oral dose of BIIB122 (DNL151) and following consecutive days of oral dosing, approximating steady state.
Detailed description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: BIIB122 (DNL151), Drug: [14C] BIIB122 ([14C] DNL151) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women of non-childbearing potential and men either with a vasectomy, using contraception, or having sex with a woman of non-childbearing potential
- Body mass index (BMI) ≥ 18 kg/m2 and ≤ 32 kg/m2
- Considered to be in good health
- Nonsmoker
Key exclusion criteria (1 listed)
- History or presence of any condition or prior surgery that, in the opinion of the investigator, poses a significant risk to subject safety and/or achievement of study objectives
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 |
|---|---|---|
| BIIB122 (DNL151)Oral doses | Drug | Cohort A |
| [14C] BIIB122 ([14C] DNL151)Intravenous doses | Drug | Cohort A |
Primary outcome
PK Parameter: The first time to maximum observed concentration (Tmax) of BIIB122 (DNL151) in plasma following oral administration
Time frame: 1 day
PK Parameter: Maximum observed concentration (Cmax) of BIIB122 (DNL151) in plasma following oral administration
Time frame: 1 day
PK Parameter: Area under the concentration-time curve (AUC) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151 in plasma following oral and intravenous administration
Time frame: 1 day
PK Parameter: Time from baseline at which half of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151 has been eliminated (t1/2) in plasma after oral and intravenous administration
Time frame: 1 day
PK Parameter: Clearance (CL/F and CL) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration
Time frame: 1 day
PK Parameter: Volume of distribution (Vd/F and Vd) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration
Time frame: 1 day
PK Parameter: Absolute bioavailability (F) of BIIB122 (DNL151) after oral administration
Time frame: 1 day
PK Parameter: The first time to maximum observed concentration (Tmax) of BIIB122 (DNL151) in plasma following oral administration
Time frame: 21 days
PK Parameter: Maximum observed concentration (Cmax) of BIIB122 (DNL151) in plasma following oral administration
Time frame: 21 days
PK Parameter: Concentration of BIIB122 (DNL151) in plasma at the end of dosing interval
Time frame: 21 days
PK Parameter: Area under the concentration-time curve of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) in plasma following oral and intravenous administration
Time frame: 21 days
PK Parameter: Time from baseline at which half of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) has been eliminated (t1/2) in plasma after oral and intravenous administration
Time frame: 21 days
PK Parameter: Volume of distribution (Vd/F and Vd) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration
Time frame: 21 days
PK Parameter: Clearance (CL/F and CL) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration
Time frame: 21 days
PK Parameter: Absolute bioavailability (F) of BIIB122 (DNL151) after oral administration
Time frame: 21 days
2 secondary outcomes
Incidence of adverse events (AEs)
Time frame: 31 days
Incidence of serious adverse events (SAEs)
Time frame: 31 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 17 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
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
Denali Therapeutics Inc.
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 BIIB122 (DNL151) and [14C] BIIB122 ([14C] DNL151) 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 4 inclusion and 1 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 17 Nov 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?
PK Parameter: The first time to maximum observed concentration (Tmax) of BIIB122 (DNL151) in plasma following oral administration (time frame: 1 day). The study lists 15 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 17 Nov 2021.