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Obeticholic acid

Phase 1

Pruritus | Small molecule | Dermatology |GSK plc|Last Updated: Nov 8, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

Obeticholic acid · 1 trial · 1 indication

Phase 1 1
NCT05133830Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult ParticipantsPruritus
COMPLETED52 Analytics
PHASE1COMPLETED
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants
PruritusUnlock trial analytics

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
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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
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about Obeticholic acid

What is obeticholic acid used for?

Obeticholic acid is a small molecule being studied for pruritus, or itching. It is in Phase 1 clinical development for this dermatologic condition. The drug is investigational and has not been approved for this use.

Who makes obeticholic acid?

Obeticholic acid is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this small molecule for pruritus.

What phase is obeticholic acid in?

Obeticholic acid is in Phase 1 clinical development for pruritus. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials.

What clinical trials is obeticholic acid in?

Obeticholic acid has one completed clinical trial, NCT05133830, titled 'Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants.' This Phase 1 study enrolled 52 participants in the United States and was a controlled, randomized trial.

Is obeticholic acid the same as linerixibat?

No, obeticholic acid and linerixibat are different drugs. They were studied together in a drug interaction trial, NCT05133830, which evaluated how they interact when administered to healthy adult participants.