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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: SB773812; Drug: Ketoconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00411866

NAA105416

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Subjects receiving ketoconazole for 8 days

Experimental group

Description:

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.

Treatment:

Drug: Ketoconazole

Drug: SB773812

Subjects receiving ketoconazole for 14 days

Experimental group

Description:

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.

Treatment:

Drug: Ketoconazole

Drug: SB773812