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BIIB122

Phase 1

Healthy Volunteers | Small molecule | Other |Biogen Inc.|Last Updated: Dec 7, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials2
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05119790A Study of Mass Balance, Pharmacokinetics, Metabolite Profile, and Metabolite Identification of BIIB122/DNL151 in Healthy Male SubjectsPHASE1 COMPLETED 7 — — Aug 27, 2021Nov 5, 2021Dec 7, 20211 United States
NCT05005338A Study to Determine the Absolute Bioavailability of BIIB122/DNL151 in Healthy SubjectsPHASE1 COMPLETED 8 — — Jul 28, 2021Sep 23, 2021Nov 17, 20211 United States
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Study Endpoints
Primary Endpoints
Mass balance (total recovery) following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)
43 days
Percentage of radioactivity recovered in urine following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)
43 days
Percentage of radioactivity recovered in feces following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)
43 days
PK Parameter: The first time to maximum observed concentration (Tmax) for total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)
43 days
PK Parameter: Maximum observed plasma concentration (Cmax) occurring at Tmax for total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)
43 days
PK Parameter: Area under the concentration-time curve (AUC) of total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)
43 days
PK Parameter: Time at which half the drug has been eliminated (T1/2) of total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C]-BIIB122 ([14C]-DNL151)
43 days
PK Parameter: Apparent systemic clearance (CL/F) of total radioactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)
43 days
PK Parameter: Apparent volume of distribution (Vz/F) of total reactivity and BIIB122 (DNL151) in blood following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)
43 days
Profiles of [14C] BIIB122 ([14C]-DNL151) and its [14C] metabolites in plasma, urine, and feces following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)
43 days
PK Parameter: The first time to maximum observed concentration (Tmax) of BIIB122 (DNL151) in plasma following oral administration
1 day
PK Parameter: Maximum observed concentration (Cmax) of BIIB122 (DNL151) in plasma following oral administration
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
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
1 day
PK Parameter: Clearance (CL/F and CL) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration
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
1 day
PK Parameter: Absolute bioavailability (F) of BIIB122 (DNL151) after oral administration
1 day
PK Parameter: Concentration of BIIB122 (DNL151) in plasma at the end of dosing interval
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
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
21 days
Secondary Endpoints
Incidence of adverse events (AEs)
43 days
PK Parameter: The ratio of total radioactivity in whole blood to that in plasma following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)
43 days
Chemical identities of the [14C] metabolites of [14C] BIIB122 ([14C]-DNL151) measured in plasma, urine, and feces
43 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort AEXPERIMENTAL -
Interventions
NameTypeDescription
[14C] BIIB122 ([14C] DNL151)DRUGOral dose
BIIB122 (DNL151)DRUGOral doses
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

key Inclusion Criteria: * For men who choose to have sex with women, either: vasectomy, use of condoms, or sex with a woman who is of non-childbearing potential * Body mass index ≥18.0 kg/m2 and ≤32.0 kg/m2 * Body weight ≥5.0 kg and ≤100.0 kg * Considered to be in good health * Non-smoker Key Excl...

Countries:United States
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