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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443170
• Other study ID #: YAK106752
• 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
• 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

• Anaemia
• Healthy Subjects

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