Schizophrenia
Conditions
Keywords
safety, pharmacokinetics,
Brief summary
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.
Interventions
DRUGSB773812
SB-773812 20 mg will be available as white round film coated tablets.
DRUGKetoconazole
Ketoconazole will be available as 200mg tablets.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood sampling over period of 336 hours post dosing with SB-773812 | over period of 336 hours post dosing |
Secondary
| Measure | Time frame |
|---|---|
| Safety: ECG, vital signs, adverse events, clinical labs over 48 hours post SB-773812 dosing. | over 48 hours post SB-773812 dosing. |
Countries
United Kingdom
Outcome results
None listed