drugset / Trial / NCT03457727

GSK1325756 Relative Bioavailability Study in Healthy Elderly Subjects

NCT03457727

Phase 1 Completed 40 enrolled GlaxoSmithKline
RandomizedCrossoverOpen-labelTreatment

Summary

This 2-part study will be carried out on healthy elderly subjects to evaluate relative bioavailability of danirixin formulations. Part A will support the selection of the formulation and Part B will assess food effect, bioavailability and pharmacokinetic (PK) profile of selected formulation from Part A. Danirixin is currently administered with food, therefore the investigation of food effect for the selected formulation could potentially enable dosing without food. Approximately 16 subjects will be included in Part A and approximately 24 subjects will be included in Part B. Both parts will include a screening phase, treatment phase with in-between washout period and a follow-up phase.

Timeline

Start
2018-03-07
Primary completion
2018-07-25
Completion
2018-07-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Danirixin Small molecule 50 mg Oral
Subject Danirixin Small molecule 475 mg Oral
Subject Danirixin Small molecule 600 mg Oral
Subject Omeprazole Other / unclassified 40 mg Oral