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

NCT02254434 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-11-13

No results posted yet for this study

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

DRUG

Eltrombopag

Eltrombopag 50 mg per tablet for oral route of administration will be sourced locally

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-28
Primary Completion
2014-09-08
Completion
2014-09-08

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02254434 on ClinicalTrials.gov