Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812
NCT ID: NCT00411866
Last Updated: 2017-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2006-10-13
2007-10-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
SB773812
SB-773812 20 mg will be available as white round film coated tablets.
Ketoconazole
Ketoconazole will be available as 200mg tablets.
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.
SB773812
SB-773812 20 mg will be available as white round film coated tablets.
Ketoconazole
Ketoconazole will be available as 200mg tablets.
Interventions
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SB773812
SB-773812 20 mg will be available as white round film coated tablets.
Ketoconazole
Ketoconazole will be available as 200mg tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 or presence gastro-intestinal,
* A hepatic or renal disease or orthostatic hypotension.
18 Years
55 Years
MALE
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Dundee, , United Kingdom
Countries
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Other Identifiers
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NAA105416
Identifier Type: -
Identifier Source: org_study_id
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