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Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00411866
First Posted: December 15, 2006
Last Update Posted: August 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Schizophrenia Drug: SB773812 Drug: Ketoconazole Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:


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. ]

Enrollment: 36
Actual Study Start Date: October 13, 2006
Study Completion Date: October 10, 2007
Primary Completion Date: October 10, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects receiving ketoconazole for 8 days
In Session 1, subjects will receive a single oral dose of SB-773812 20 milligrams (mg), followed by 21 days-washout. In Session 2, subjects will receive once daily oral dose of ketoconazole 400 mg repeated for 8 days. On day 5, single oral dose of SB-773812 20 mg will be dosed concomitantly with ketoconazole.
Drug: SB773812
SB-773812 20 mg will be available as white round film coated tablets.
Drug: Ketoconazole
Ketoconazole will be available as 200mg tablets.
Other Name: SB773812
Experimental: Subjects receiving ketoconazole for 14 days
In Session 1, subjects will receive a single oral dose of SB-773812 (20mg), followed by 21 days-washout. In Session 2, subjects will receive once daily oral dose of ketoconazole 400 mg repeated for 12 days. On day 5, single oral dose of SB-773812 20 mg will be dosed concomitantly with ketoconazole.
Drug: SB773812
SB-773812 20 mg will be available as white round film coated tablets.
Drug: Ketoconazole
Ketoconazole will be available as 200mg tablets.
Other Name: SB773812

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00411866


Locations
United Kingdom
GSK Investigational Site
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00411866     History of Changes
Other Study ID Numbers: NAA105416
First Submitted: December 13, 2006
First Posted: December 15, 2006
Last Update Posted: August 3, 2017
Last Verified: August 2017

Keywords provided by GlaxoSmithKline:
safety
pharmacokinetics,

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Ketoconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors