A Randomized, Blinded, Placebo-controlled Study to Investigate the Safety, and Pharmacokinetics of Single and Repeat Dose Escalation of the Oral YAK3/DYRK3 Inhibitor GSK626616AC in Healthy Subjects

GlaxoSmithKline1 site in 1 country90 target enrollmentNovember 2006

ConditionsHealthy Subjects Anaemia

DrugsGSK626616, placebo, midazolam omeprazole, caffeine, flurbiprofen, rosiglitazone

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy Subjects
Sponsor: GlaxoSmithKline
Enrollment: 90
Locations: 1
Primary Endpoint: adverse events at end of each cohort
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a first time in human study to investigate the safety of GSK626616AC given as oral single and repeat doses in healthy subjects. An additional group of subjects will be assessed to determine the effect of several drugs given at the same time as GSK626616.

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 to 55 years healthy subjects
•Hemoglobin values of 13.5-17.0 g/dL for males or 12.0-15.5 g/dL for females.
•Females cannot be pregnant.

Exclusion Criteria

•Cannot have exposure to greater than 4 new chemical entities within 12 months.
•Cannot have a clinical history of current alcohol, or illicit drug use which, in the judgment of the Investigator, would interfere with the subject's ability to comply with the dosing schedule.
•Cannot have a history of regular use of tobacco- or nicotine-containing products within 3 months.
•Must not have received a blood transfusion or had a donation of blood within 3 months prior to study entry.
•Cannot use be taking prescription, non-prescription or illicit drugs.