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

GlaxoSmithKline36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

SB773812DRUG

SB-773812 20 mg will be available as white round film coated tablets.

KetoconazoleDRUG

Ketoconazole will be available as 200mg tablets.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Dundee, United Kingdom

Outcomes

Primary Outcomes

Blood sampling over period of 336 hours post dosing with SB-773812

Time frame: over period of 336 hours post dosing

Secondary Outcomes

Safety: ECG, vital signs, adverse events, clinical labs over 48 hours post SB-773812 dosing.

Time frame: over 48 hours post SB-773812 dosing.

Data from ClinicalTrials.gov

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