NCT02045849

Relative Bioavailability, Safety, Tolerability, Pharmacokinetics (PK) and Food Effect Study of GSK2140944 in Healthy Subjects

A Single-Center, Three-Part, Open Label Study to Evaluate the Relative Bioavailability of Two Formulations, Food Effect, and Interaction With Itraconazole Following Single Dose of GSK2140944 in Healthy Subjects and Effect of Food on Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of GSK2140944 in Healthy Elderly Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will be conducted in three parts (Part 1, Part 2 and Part 3). Part 1 of this study will evaluate the relative bioavailability of a single dose of GSK2140944 tablet formulation compared to the reference capsule formulation under fasted conditions. The effect of food on the pharmacokinetics (PK) of a single dose of the tablet formulation will also be assessed. Part 2 will evaluate the effect of repeat doses of itraconazole on the pharmacokinetics of GSK2140944 following a single dose. A decision will be made whether to use the current capsule formulation or the new tablet formulation in Part 2 based upon the safety and PK data obtained from Part 1. Part 3 is conditionally based upon progression of the tablet formulation from Part 1 and will evaluate the effect of food on the safety, tolerability, and pharmacokinetics of the tablet formulation following multiple doses in elderly healthy subjects.

Conditions

• Infections, Bacterial

Interventions

Type	Name	Description
DRUG	GSK2140944 capsule	Immediate release capsule containing GSK2140944 and inactive formulation excipients with a unit dose strength of 500 mg
DRUG	GSK2140944 tablet	Immediate release tablet containing GSK2140944 and inactive formulation excipients with a unit dose strength of 750 mg
DRUG	Itraconazole capsule	Capsule containing Itraconazole with a unit dose strength of 100 mg

Timeline

• Start date: 2014-01-28
• Primary completion: 2014-08-21
• Completion: 2014-08-21
• First posted: 2014-01-27
• Last updated: 2017-07-13

Locations

1 site across 1 country: United States