Recent Updates
Recently added Catalysts

Obeticholic acid

Phase 1

Pruritus | Small molecule | Dermatology |GSK plc|Last Updated: Nov 8, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05133830Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult ParticipantsPHASE1 COMPLETED 52 — — Nov 23, 2021May 31, 2022Nov 8, 20221 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Average trough concentration (Ctrough) in plasma for total-OCA at steady state
Days 35 to 38
Secondary Endpoints
Area under the concentration curve from time 0 to t (AUC0-t) for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state
At Day 18 and Day 37
AUC from time 0 to 24 hour (AUC0-24) for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state
Up to 24 hours on Day 18 and Day 37
Maximum observed plasma concentration (Cmax) for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state
At Day 18 and Day 37
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment Arm 1EXPERIMENTALParticipants will receive OCA at dose level 1, 4 hours after the linerixibat administration
Treatment Arm 2EXPERIMENTALParticipants will receive OCA at dose level 2 along with linerixibat
Treatment Arm 3EXPERIMENTALParticipants will receive OCA at dose level 1 along with linerixibat
Treatment Arm 4EXPERIMENTALParticipants will receive OCA at dose level 2, 4 hours after the linerixibat administration
Interventions
NameTypeDescription
Obeticholic acidDRUGOCA will be administered
LinerixibatDRUGLinerixibat will be administered
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overtly healthy male or female participants 18 to 50 years of age inclusive, at the time of signing the informed consent * Body weight greater than (\>) 50 kilogram (kg) and body mass index (BMI) within the range 18.5 - 32 kilogram per meter square (kg/m\^2) (inclusive) * Capa...

Countries:United States
Unlock Eligibility Criteria