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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00750256 |
A first-time in human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1278863A in healthy subjects
Condition | Intervention | Phase |
---|---|---|
Anemia |
Drug: GSK1278863A |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Single Group Assignment, Safety Study |
Official Title: | A Phase I, Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of GSK1278863A in Healthy Subjects |
Estimated Enrollment: | 36 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Female subjects are eligible for participation in the study if they are of:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
United States, Indiana | |
GSK Investigational Site | Recruiting |
Evansville, Indiana, United States, 47710 |
Study Director: | GSK Clinical Trials, MD, PhD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | PHX111427 |
Study First Received: | September 9, 2008 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00750256 |
Health Authority: | United States: Food and Drug Administration |
Safety tolerability pharmacokinetics |
Anemia Healthy |