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

Study Overview
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Brief Summary
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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.

Official Title
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Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole 400mg on Pharmacokinetics of SB-773812 20mg

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: SB773812
* Drug: Ketoconazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects receiving ketoconazole for 8 days<br>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<br>* SB-773812 20 mg will be available as white round film coated tablets.<br>Drug: Ketoconazole<br>* Ketoconazole will be available as 200mg tablets.<br>* Other names: SB773812;|
| Experimental: Subjects receiving ketoconazole for 14 days<br>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<br>* SB-773812 20 mg will be available as white round film coated tablets.<br>Drug: Ketoconazole<br>* Ketoconazole will be available as 200mg tablets.<br>* Other names: SB773812;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood sampling over period of 336 hours post dosing with SB-773812 |  | over period of 336 hours post dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: ECG, vital signs, adverse events, clinical labs over 48 hours post SB-773812 dosing. |  | over 48 hours post SB-773812 dosing. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, pharmacokinetics,