Last updated: 11/04/2018 09:21:34
Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole 400mg on Pharmacokinetics of SB-773812 20mg
Trial description: 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.
Primary purpose:
Diagnostic
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Blood sampling over period of 336 hours post dosing with SB-773812
Timeframe: over period of 336 hours post dosing
Secondary outcomes:
Safety: ECG, vital signs, adverse events, clinical labs over 48 hours post SB-773812 dosing.
Timeframe: over 48 hours post SB-773812 dosing.
Interventions:
Drug: SB773812
Drug: Ketoconazole
Enrollment:
36
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Schizophrenia
Product
SB773812
Collaborators
Not applicable
Study date(s)
October 2006 to October 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Healthy
- Body Weight >/=50kg and BMI 18.5-29.9 kg/m2 inclusive
- A history of psychiatric illness,
- A history or presence gastro-intestinal,
Inclusion and exclusion 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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-10-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study NAA105416 can be found on the GSK Clinical Study Register.
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