Food Effect Study of Linerixibat Tablets in Healthy Adult Participants
- Registration Number
- NCT05435170
- Lead Sponsor
- GlaxoSmithKline
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment sequence BA linerixibat Participants will receive linerixibat in fasted state (Treatment B) in period 1 followed by linerixibat in fed state (Treatment A) in period 2. The washout period will be of at least 7 days. Treatment sequence AB linerixibat Participants will receive linerixibat in fed state (Treatment A) in period 1 followed by linerixibat in fasted state (Treatment B) in period 2. The washout period will be of at least 7 days.
- Primary Outcome Measures
Name Time Method Plasma linerixibat area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration [AUC(0-t)] Up to 36 hours post dose Maximum observed plasma concentration (Cmax) of linerixibat Up to 36 hours post dose
- Secondary Outcome Measures
Name Time Method Apparent terminal phase half-life (t1/2) of linerixibat Up to 36 hours post dose Apparent terminal phase volume of distribution (Vz/F) of linerixibat Up to 36 hours post dose Plasma linerixibat area under the concentration-time curve from time zero (pre-dose) to 24 hour [AUC (0-24)] Up to 24 hours post dose Apparent clearance (CL/F) of linerixibat Up to 36 hours post dose Incidence of adverse events (AEs) and of serious adverse events (SAEs) Up to day 52 Plasma linerixibat area under the concentration-time curve from time zero (pre-dose) to infinite time [AUC (0-∞)] Up to 36 hours post dose Time of occurrence of Cmax (Tmax) of linerixibat Up to 36 hours post dose Serum C4 area under the concentration-time curve from time zero (pre-dose) to 24 hour [AUC (0-24)] Up to 24 hours post dose Delay in achieving Tmax (Tlag) of linerixibat Up to 36 hours post dose Serum C4 area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration [AUC(0-t)] Up to 36 hours post dose
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧Cambridge, United Kingdom