food effect study of linerixibat tablets in healthy adult participants

Conditions: Pruritus

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


Eligibility 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.

Keywords: pharmacokinetic pharmacodynamic food effect ileal bile acid transporter (ibat) inhibitor linerixibat