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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00443170
Other study ID # YAK106752
Secondary ID
Status Completed
Phase Phase 1
First received March 1, 2007
Last updated March 15, 2012
Start date November 2006

Study information

Verified date February 2011
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
GSK626616, placebo, midazolam

omeprazole, caffeine, flurbiprofen, rosiglitazone


Locations

Country Name City State
Australia GSK Investigational Site Adelaide South Australia
Australia GSK Investigational Site Herston Queensland
Australia GSK Investigational Site Randwick, Sydney New South Wales

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary adverse events at end of each cohort end of each cohort
Primary hematology/chemistry/urinalysis at end of each cohort end of each cohort
Primary physical examination at end of each cohort end of each cohort
Primary vital signs and electrocardiogram (ECG) at end of each cohort end of each cohort
Secondary GSK626616 pharmacokinetics at end of each cohort end of each cohort
Secondary hemoglobin at end of each cohort end of each cohort
Secondary red blood cell measurements at end of each cohort end of each cohort
Secondary estimates of CYP enzyme activity at end of study end of study
Secondary mRNA levels in peripheral blood at end of study end of study
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