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

Sponsored by:	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

MedlinePlus related topics: Caffeine

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Single Group Assignment, Safety Study
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

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

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:	GSK ( Study Director )
Study ID Numbers:	YAK106752
Study First Received:	March 1, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00443170 History of Changes
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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Neurotransmitter Agents
Psychotropic Drugs
Anesthetics
Omeprazole
Healthy
Hypoglycemic Agents
Hypnotics and Sedatives
Caffeine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Rosiglitazone
Caffeine citrate
Anesthetics, Intravenous

Tranquilizing Agents
Cyclooxygenase Inhibitors
Adjuvants, Immunologic
Central Nervous System Depressants
Central Nervous System Stimulants
Midazolam
Phosphodiesterase Inhibitors
Flurbiprofen
Anesthetics, General
Analgesics, Non-Narcotic
Anti-Anxiety Agents
Peripheral Nervous System Agents
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Omeprazole
Anesthetics
Hypoglycemic Agents
Sensory System Agents
Therapeutic Uses
Anti-Ulcer Agents
Hypnotics and Sedatives
Anti-Inflammatory Agents, Non-Steroidal
Caffeine

Analgesics
Rosiglitazone
Anesthetics, Intravenous
Tranquilizing Agents
Cyclooxygenase Inhibitors
Gastrointestinal Agents
Central Nervous System Depressants
Central Nervous System Stimulants
Enzyme Inhibitors
Midazolam
Pharmacologic Actions
Adjuvants, Anesthesia
Phosphodiesterase Inhibitors
Analgesics, Non-Narcotic
Flurbiprofen

ClinicalTrials.gov processed this record on May 07, 2009