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

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: SB773812; Drug: Ketoconazole

• Registration Number: NCT00411866
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-13
• Study First Submitted: 2006-12-13
• Study First Submitted QC: 2006-12-14
• Study First Posted: 2006-12-15
• Primary Completion: 2007-10-10
• Study Completion: 2007-10-10
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects receiving ketoconazole for 8 days	Ketoconazole	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.
Subjects receiving ketoconazole for 14 days	Ketoconazole	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.
Subjects receiving ketoconazole for 8 days	SB773812	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.
Subjects receiving ketoconazole for 14 days	SB773812	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Dundee, United Kingdom