NCT02254434

A Pharmacokinetic Study of Eltrombopag 50 Milligram (mg) in Healthy Volunteers Under Fasting Conditions

An Open-label Single-dose Pharmacokinetic Study of an Oral Formulation in Tablets Containing Eltrombopag 50 mg (Revolade, Glaxosmithkline Mexico, S.A. De C.V.) in Healthy Volunteers Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study evaluates pharmacokinetics of eltrombopag 50 mg after the oral administration in Mexican healthy volunteers under fasting conditions. The study will be an open label, single dose study with 26 subjects planned to be enrolled. Healthy subjects (male and female) aged between 18 - 50 years of age (inclusive) and a Body Mass Index within the range of 18-27.0 kg/meter (m)\^2 (inclusive) were enrolled according to Quetelet. REVOLADE is a registered trademark of the GSK group of companies.

Conditions

• Cirrhosis, Liver

Interventions

Type	Name	Description
DRUG	Eltrombopag	Eltrombopag 50 mg per tablet for oral route of administration will be sourced locally

Timeline

• Start date: 2014-08-28
• Primary completion: 2014-09-08
• Completion: 2014-09-08
• First posted: 2014-10-01
• Last updated: 2017-11-13

Locations

1 site across 1 country: Mexico