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Single dose reduced

Phase 1

Amyotrophic Lateral Sclerosis | Small molecule | Neurology |Biogen Inc.|Last Updated: Jun 22, 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
CONTROLLED
Total Trials1
Total Enrollment57
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01424163Dexpramipexole Japanese PK StudyPHASE1 COMPLETED 57 — — Aug 1, 2011Feb 1, 2012Jun 22, 20211 United Kingdom
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Study Endpoints
Primary Endpoints
Cmax of dexpramipexole
pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours after dosing on Days 1 and 5 in Treatments 1 and 2, and after the fifth dose on Day 11 in Treatment 3 for Parts A & B.
AUC of dexpramipexole
pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours after dosing on Days 1 and 5 in Treatments 1 and 2, and after the fifth dose on Day 11 in Treatment 3 for Parts A & B.
Secondary Endpoints
Changes in clinical laboratory tests
pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose)
ECG changes
pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose)
Vital Sign changes
pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Treatment 1 (Part A)EXPERIMENTALDexpramipexole single dose (reduced dose)
Treatment 2 (Part A)EXPERIMENTALDexpramipexole single dose (Standard dose)
Treatment 3 (Part A)EXPERIMENTALDexpramipexole multiple dosing
Treatment for Part BEXPERIMENTALDexpramipexole multiple dosing
Interventions
NameTypeDescription
Single dose reducedDRUGTreatment 1 (Part A)
Single dose standardDRUGTreatment 2 (Part A)
Multiple DoseDRUGTreatment 3 (Part A)
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects who are able and willing to give written informed consent. * Adult Japanese and Caucasian males/females aged 18 to 60 years inclusive and between 18 and 30 kg/m2 body mass index (BMI), inclusive. * Male and female subjects will be enrolled on the study. Male subjects ...

Countries:United Kingdom
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