At a glance
ClinicalIndex Comparison Record- ✓Age 18-80 years inclusive at informed consent
- ✓Healthy as determined by investigator, based on medical history, physical exam, vital signs, labs, and ECG
- ✓Body weight >50 kg and BMI 18.5-32 kg/m² inclusive
- ✓Capable of giving signed informed consent and compliance with protocol
- ✕Any active dermatologic disorder causing or potentially causing pruritus or recent unexplained significant itching within prior 3 months
- ✕Current or chronic liver disease, hepatic/biliary abnormalities (except Gilbert's syndrome or asymptomatic gallstones), hepatocellular carcinoma, or biliary cancer
- ✕History of cholecystectomy
- ✕Current symptomatic cholelithiasis or inflammatory gallbladder disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Single Sequence Crossover, Drug Interaction Study to Investigate the Effect of Linerixibat (GSK2330672) on Plasma Concentrations of Obeticholic Acid and Conjugates in Healthy Participants
In Brief
A Phase 1 clinical trial evaluating GSK2330672 (linerixibat) and Obeticholic acid for Cholestasis. Completed, enrolled 19 participants across 1 site.
Detailed Summary
In participants with inadequate response/intolerance to ursodeoxycholic acid (UDCA) taking obeticholic acid (OCA) who experience pruritus (due to primary biliary cholangitis \[PBC\], OCA, or both) the addition of linerixibat to OCA therapy may be considered following marketing approval. It is therefore important to characterize any potential effect of linerixibat on the pharmacokinetics of OCA in humans at clinically relevant dosages. Accordingly, a drug-drug interaction (DDI) study with linerixibat (potential perpetrator) and OCA (potential victim) will be conducted to inform both future clinical trials with linerixibat and the potential concomitant administration of these drugs in a clinical setting. This is a single-center, one part (with optional second part) open-label, single sequence crossover, drug interaction study to investigate the effect of linerixibat on plasma concentrations of OCA and OCA conjugates in healthy participants. Approximately 19 participants will be enrolled in part A and further 19 participants in part B (if performed) in the study and will have a phone call follow-up till 7-14 days post-last linerixibat dose.
Study Details
Timeline
Interventions
GSK2330672 is available as a tablet with unit dose strength of 45 mg.
Obeticholic acid is available as a tablet with a unit dose strength of 10 mg (or 5 mg dependent on evaluation of Part A).