Food Effect Study of Linerixibat Tablets in Healthy Adult Participants

• Status: Not yet recruiting
• Trial end date: 2022-08-11
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the effect of food on the Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters of linerixibat administered in fed and fasted states in heathy adult participants

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion criteria:

• Overtly healthy male or female participants 18 to 55 years of age inclusive, at the time of signing the informed consent.

• Participants' age greater than (>) 50 years old, must have had at least 3 weeks elapsed after the completion of an approved primary SARS-CoV-2 vaccination course.

• Body weight >50 kg and body mass index (BMI) within the range 18.5 - 32 kilogram per meter square (kg/m2) (inclusive).

• Female Participants:

• A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:

• Is a woman of non-childbearing potential (WONCBP). OR

• Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of <1% per year).

• Capable of giving signed informed consent.

Exclusion Criteria:

• History of cholecystectomy.

• Current symptomatic cholelithiasis or inflammatory gall bladder disease.

• Significant history of or current disorders capable of significantly altering 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) 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 Medical Monitor.

• Current enrollment in a clinical trial or recent participation in a clinical trial and has received an investigational product within the following time period prior to study drug administration: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).

• 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 >1.5x ULN (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

• Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody test or hepatitis C Ribonucleic acid (RNA) test at screening or within 3 months prior to first dose of study intervention.

• Positive human immunodeficiency virus (HIV) antibody test

• Fridericia's QT correction formula (QTcF) >450 msec on ECG performed at screening.

• Regular use of known drugs of abuse or history of drug abuse or dependence within 6 months of the study.

• Regular alcohol consumption within 6 months prior to signing the informed consent.

• Regular use of tobacco- or nicotine-containing products in the 3 months prior to screening.