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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
December 13, 2006
December 15, 2006
August 3, 2017
October 13, 2006
October 10, 2007   (Final data collection date for primary outcome measure)
Blood sampling over period of 336 hours post dosing with SB-773812 [ Time Frame: over period of 336 hours post dosing ]
Blood sampling over period of 336 hours post dosing with SB-773812
Complete list of historical versions of study NCT00411866 on ClinicalTrials.gov Archive Site
Safety: ECG, vital signs, adverse events, clinical labs over 48 hours post SB-773812 dosing. [ Time Frame: over 48 hours post SB-773812 dosing. ]
Safety: ECG, vital signs, adverse events, clinical labs over 48 hours post SB-773812 dosing.
Not Provided
Not Provided
 
Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812
Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole 400mg on Pharmacokinetics of SB-773812 20mg
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Schizophrenia
  • 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 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.
    Interventions:
    • Drug: SB773812
    • Drug: Ketoconazole
  • 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.
    Interventions:
    • Drug: SB773812
    • Drug: Ketoconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
October 10, 2007
October 10, 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00411866
NAA105416
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP