Recent Updates
Recently added Catalysts

-PBI-200

Phase 1

Absorption, Metabolism and Excretion in Healthy Volunteers | Small molecule | Other |Biohaven Ltd.|Last Updated: Aug 30, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05238337A Phase 1 Study of the Absorption, Metabolism, and Excretion of [14C] PBI-200PHASE1 COMPLETED 6 — — Feb 24, 2022Mar 24, 2022Aug 30, 20221 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Total Radioactivity in Urine and Feces
28 days
Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to infinity [AUC(0-inf)]
28 days
Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of the last quantifiable concentration [AUC(0-tlast)
28 days
Maximum Observed Concentration [C(max)]
28 days
Time to Maximum Concentration [T(max)]
28 days
Apparent Terminal Elimination Half-life [t(1/2)]
28 days
Total Radioactivity in Plasma and Whole Blood
28 days
Ratio for AUC(0-inf) Blood / Plasma
28 days
Ratio for AUC(0-inf) Plasma PBI-200 / Total Radioactivity
28 days
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
[14C]-PBI-200 TreatedEXPERIMENTAL\[14C\]-labeled PBI-200 will be administered as a single dose
Interventions
NameTypeDescription
[14C]-PBI-200DRUG\[14C\]-radio-labeled-PBI-200
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Males, of any race, 18 to 65 years of age as of the dosing day. * Body mass index between 18.0 and 32.0 kg/m2, inclusive. * Non-smoking/non-vaping, healthy, with no history of clinically relevant medical illness. Key Exclusion Criteria: * Significant history or clinical ...

Countries:United States
Unlock Eligibility Criteria