A Placebo-Controlled Study to Investigate the Safety, and Pharmacokinetics of Oral GSK626616AC in Healthy Subjects

Condition(s) targeted: Healthy Volunteers

Intervention: GSK626616, placebo, midazolam (Drug); omeprazole, caffeine, flurbiprofen, rosiglitazone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: 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

Study design: Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety Study

Primary outcome:

adverse events at end of each cohort

hematology/chemistry/urinalysis at end of each cohort

physical examination at end of each cohort

vital signs and electrocardiogram (ECG) at end of each cohort

Secondary outcome:

GSK626616 pharmacokinetics at end of each cohort

hemoglobin at end of each cohort

red blood cell measurements at end of each cohort

estimates of CYP enzyme activity at end of study

mRNA levels in peripheral blood at end of study

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

GSK Clinical Trials Call Center, Adelaide 5000, Australia

GSK Clinical Trials Call Center, Randwick 2031, Australia

GSK Clinical Trials Call Center, Brisbane 4028, Australia

Starting date: November 2006
Last updated: September 25, 2007