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BIIB104

Phase 1

Healthy Volunteers | Small molecule | Other |Biogen Inc.|Last Updated: Apr 18, 2023

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
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials3
Total Enrollment97
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05152485A 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 ParticipantsPHASE1 COMPLETED 36 — — Dec 15, 2021Jan 31, 2022Apr 18, 20231 United States
NCT04068532A Study to Explore Pharmacodynamic Effects of BIIB104 on Brain Circuitry in Healthy ParticipantsPHASE1 COMPLETED 30 — — Nov 15, 2019Nov 11, 2020Mar 22, 20211 United Kingdom
NCT04079101Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese ParticipantsPHASE1 COMPLETED 31 — — Oct 2, 2019Dec 27, 2019Mar 24, 20211 United States
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Study Endpoints
Primary Endpoints
Area Under the Plasma Concentration-Time Curve from Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB104
Up to Day 6
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUCinf) of BIIB104
Up to Day 6
Maximum Observed Plasma Concentration (Cmax) of BIIB104
Up to Day 6
Time to Reach Maximum Observed Plasma Concentration (Tmax) for BIIB104
Up to Day 6
Change From Baseline in Faces Versus Shapes Emotional Faces Task Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Contrasts to Day 4 Within a Priori Defined Regions of Interest
Baseline, Day 4
Maximum Observed Concentration of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Time to Reach Maximum Observed Concentration of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Area Under the Concentration-Time Curve Within a Dosing Interval (AUCtau) of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Maximum Observed Concentration at Steady State of BIIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Time to Reach Maximum Observed Concentration at Steady State of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Area Under the Concentration-Time Curve Over a Uniform Dosing Interval Tau at Steady State of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Apparent Total Body Clearance of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Apparent Volume of Distribution of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Elimination Half-Life of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Accumulation Ratio at Steady State of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Trough Concentration of BIIB104
pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Secondary Endpoints
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
From Day 1 up to end of study (up to Day 16)
Number of Participants with Clinically Significant Abnormalities in Clinical Laboratory Parameters
From Day 1 up to end of study (up to Day 16)
Number of Participants with Clinically Significant Abnormalities in Vital Signs
From Day 1 up to end of study (up to Day 16)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BIIB104 0.5 mg Reference Formulation (Fasted State)ACTIVE_COMPARATORParticipants 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)EXPERIMENTALParticipants 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)EXPERIMENTALParticipants will receive BIIB104 0.5 mg, immediate-release softgel capsule, orally, on Day 1 in the fed state.
PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo to BIIB104 on Days 1-4 in treatment periods 1 or 2.
BIIB104EXPERIMENTALParticipants will receive BIIB104 on Days 1-4 in treatment periods 1 or 2.
BIIB104 0.15 mgEXPERIMENTALParticipants will receive multiple oral doses of BIIB104 0.15 mg capsules twice daily (BID) for 9 days, with an additional dose occurring in the morning on Day 10.
BIIB104 0.5 mgEXPERIMENTALParticipants will receive multiple oral doses of BIIB104 0.5 mg capsules BID for 9 days, with an additional dose occurring in the morning on Day 10.
Interventions
NameTypeDescription
BIIB104 Reference FormulationDRUGAdministered as specified in the treatment arm
BIIB104 Test FormulationDRUGAdministered as specified in the treatment arm
PlaceboDRUGAdministered as specified in the treatment arm.
BIIB104DRUGAdministered as specified in the treatment arm.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * 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: * Participates in other studies involving treatment with an investigational drug within 30 days...

Countries:United StatesUnited Kingdom
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