Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812 - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00411866

Purpose

The purposes of this study are to determine if there is a difference in how SB-773812 is distributed through the bloodstream before and after multiple doses of ketoconazole have been given and to determine if there is a difference in how safe and well tolerated SB-773812 is when given on its own and given with ketoconazole.

Condition	Intervention	Phase
Healthy Subjects	Drug: SB773812 Drug: Ketoconazole	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole 400mg on Pharmacokinetics of SB-773812 20mg.

Resource links provided by NLM:

Drug Information available for: Ketoconazole Fungarest

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Blood sampling over period of 336 hours post dosing with SB-773812 [ Time Frame: over period of 336 hours post dosing ]

Secondary Outcome Measures:

Safety: ECG, vital signs, adverse events, clinical labs over 48 hours post SB-773812 dosing. [ Time Frame: over 48 hours post SB-773812 dosing. ]

Estimated Enrollment:	36
Study Start Date:	October 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Other Names:

SB773812
Ketoconazole

Eligibility

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

Criteria

Inclusion criteria:

Healthy
Body Weight >/=50kg and BMI 18.5-29.9 kg/m2 inclusive
Normal 12-lead ECG, physical examination and lab screen

Exclusion criteria:

A history of psychiatric illness,
A history or presence gastro-intestinal,
A hepatic or renal disease or orthostatic hypotension.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411866

Locations

United Kingdom
GSK Investigational Site
Dundee, Forfarshire, United Kingdom, DD1 9SY

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00411866 History of Changes
Other Study ID Numbers:	NAA105416
Study First Received:	December 13, 2006
Last Updated:	October 13, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

pharmacokinetics,
safety

Additional relevant MeSH terms:

Ketoconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012