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

Tracking Information

First Received Date ^ICMJE

March 1, 2007

Last Updated Date

May 15, 2009

Start Date ^ICMJE

November 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

adverse events at end of each cohort [ Time Frame: end of each cohort ]
hematology/chemistry/urinalysis at end of each cohort [ Time Frame: end of each cohort ]
physical examination at end of each cohort [ Time Frame: end of each cohort ]
vital signs and electrocardiogram (ECG) at end of each cohort [ Time Frame: end of each cohort ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00443170 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

GSK626616 pharmacokinetics at end of each cohort [ Time Frame: end of each cohort ]
hemoglobin at end of each cohort [ Time Frame: end of each cohort ]
red blood cell measurements at end of each cohort [ Time Frame: end of each cohort ]
estimates of CYP enzyme activity at end of study [ Time Frame: end of study ]
mRNA levels in peripheral blood at end of study [ Time Frame: end of study ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Single Group Assignment, Safety Study

Condition ^ICMJE

Healthy Subjects

Intervention ^ICMJE

Drug: GSK626616, placebo, midazolam
Drug: omeprazole, caffeine, flurbiprofen, rosiglitazone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT ID ^ICMJE

NCT00443170

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

YAK106752

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP