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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00443170

Purpose

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.

Condition	Intervention	Phase
Healthy Subjects	Drug: GSK626616, placebo, midazolam Drug: omeprazole, caffeine, flurbiprofen, rosiglitazone	Phase I

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

Resource links provided by NLM:

MedlinePlus related topics: Caffeine

Drug Information available for: 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione Flurbiprofen sodium Midazolam Midazolam maleate Midazolam hydrochloride Omeprazole Omeprazole magnesium Rosiglitazone Rosiglitazone Maleate Esomeprazole Sodium Esomeprazole magnesium Flurbiprofen

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	90
Study Start Date:	November 2006

Intervention Details:

Other Names:

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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443170

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00443170 History of Changes
Other Study ID Numbers:	YAK106752
Study First Received:	March 1, 2007
Last Updated:	May 15, 2009
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:

First time in human,
GSK626616AC,
pharmacokinetic,
single dose,

repeat dose,
cytochrome P450,
healthy volunteers

Additional relevant MeSH terms:

Caffeine
Midazolam
Flurbiprofen
Omeprazole
Rosiglitazone
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists

Purinergic Agents
Neurotransmitter Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on February 12, 2012