Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants

NCT ID: NCT05133830

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-23
• Study Completion Date: 2022-05-31

Brief Summary

This study aims to investigate the effect of linerixibat on plasma concentrations of obeticholic acid (OCA) and its conjugates in healthy adult participants to inform the potential for drug interaction with coadministration of linerixibat and OCA.

Conditions

Pruritus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm 1

Participants will receive OCA at dose level 1, 4 hours after the linerixibat administration

Group Type: EXPERIMENTAL

Obeticholic acid

Intervention Type: DRUG

OCA will be administered

Linerixibat

Intervention Type: DRUG

Linerixibat will be administered

Treatment Arm 2

Participants will receive OCA at dose level 2 along with linerixibat

Group Type: EXPERIMENTAL

Obeticholic acid

Intervention Type: DRUG

OCA will be administered

Linerixibat

Intervention Type: DRUG

Linerixibat will be administered

Treatment Arm 3

Participants will receive OCA at dose level 1 along with linerixibat

Group Type: EXPERIMENTAL

Obeticholic acid

Intervention Type: DRUG

OCA will be administered

Linerixibat

Intervention Type: DRUG

Linerixibat will be administered

Treatment Arm 4

Participants will receive OCA at dose level 2, 4 hours after the linerixibat administration

Group Type: EXPERIMENTAL

Obeticholic acid

Intervention Type: DRUG

OCA will be administered

Linerixibat

Intervention Type: DRUG

Linerixibat will be administered

Interventions

Obeticholic acid

OCA will be administered

Intervention Type: DRUG

Linerixibat

Linerixibat will be administered

Intervention Type: DRUG

Eligibility Criteria

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)
• Capable of giving signed informed consent as the protocol.

Exclusion Criteria

• Any active dermatologic disorder leading to or with the potential to cause itching or a recent history of unexplained clinically significant itching locally or generally within the prior 3 months
• Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) and/or confirmed hepatocellular carcinoma or biliary cancer
• History of gall bladder removal
• Current symptomatic gallstones or inflammatory gall bladder disease
• Significant history of or current disorders that can significantly alter the absorption, metabolism, or elimination of drugs
• Current clinically significant diarrhea
• History of gastrointestinal surgery with ileal resection or ileal bypass at any time
• Any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
• Administration of any other ileal bile acid transport (IBAT) inhibitor (including linerixibat) or Ocaliva in the 3 months prior to screening
• Past or intended use of over-the-counter or prescription medication, including vitamins and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inhibitor) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless approved by the Investigator in conjunction with GSK
• Current enrolment in a clinical trial or recent participation in a clinical trial and has received an investigational product within 30 days before the first dose in the current study
• Exposure to more than 4 new chemical entities within 12 months before the first dose in the current study
• Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5x upper limit of normal (ULN)
• Bilirubin >1.5xULN (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin lesser than (<)35%
• Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test or positive hepatitis C riboneucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention
• Positive pregnancy test at screening or at Day -1
• Positive human immunodeficiency virus (HIV) antibody test
• QT interval corrected (QTc) >450 millisecond (msec)
• Regular use of known drugs of abuse or history of drug abuse or dependence within 6 months of the study
• Participants with moderate (or greater) alcohol consumption
• History of or regular use of tobacco- or nicotine-containing products in the 3 months prior to screening.
• Female participants unable or unwilling to comply with specific contraception restrictions as detailed in the protocol
• Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within a 56-day period
• Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

213688

Identifier Type: -

Identifier Source: org_study_id