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

March 15, 2012 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- New South Wales
  - Randwick, Sydney, New South Wales, Australia, 2031
    - GSK Investigational Site
- Queensland
  - Herston, Queensland, Australia, 4006
    - GSK Investigational Site
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Registration Dates

First Submitted

March 1, 2007

First Submitted That Met QC Criteria