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

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

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 Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: SB773812; Drug: Ketoconazole

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Dundee, United Kingdom, DD1 9SY
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Subjects receiving ketoconazole for 8 days; 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; SB-773812 20 mg will be available as white round film coated tablets.; Drug: Ketoconazole; Ketoconazole will be available as 200mg tablets.; Other Names: SB773812
EXPERIMENTAL: Subjects receiving ketoconazole for 14 days; 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; SB-773812 20 mg will be available as white round film coated tablets.; Drug: Ketoconazole; Ketoconazole will be available as 200mg tablets.; Other Names: SB773812

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 13, 2006
• Primary Completion (ACTUAL): October 10, 2007
• Study Completion (ACTUAL): October 10, 2007

Study Registration Dates

• First Submitted: December 13, 2006
• First Submitted That Met QC Criteria: December 14, 2006
• First Posted (ESTIMATE): December 15, 2006

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 2, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: safety; pharmacokinetics,
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Ketoconazole
• Other Study ID Numbers: NAA105416