Back to resultsEffects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
SB773812
Ketoconazole
Sponsored by
About this trial
This is an interventional diagnostic trial for Schizophrenia focused on measuring safety, pharmacokinetics,
Eligibility Criteria
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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Subjects receiving ketoconazole for 8 days
Subjects receiving ketoconazole for 14 days
Arm 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.
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.
Outcomes
Primary Outcome Measures
Blood sampling over period of 336 hours post dosing with SB-773812
Secondary Outcome Measures
Safety: ECG, vital signs, adverse events, clinical labs over 48 hours post SB-773812 dosing.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00411866
Brief Title
Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812
Official Title
Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole 400mg on Pharmacokinetics of SB-773812 20mg
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 13, 2006 (Actual)
Primary Completion Date
October 10, 2007 (Actual)
Study Completion Date
October 10, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
safety, pharmacokinetics,
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects receiving ketoconazole for 8 days
Arm Type
Experimental
Arm 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.
Arm Title
Subjects receiving ketoconazole for 14 days
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
SB773812
Intervention Description
SB-773812 20 mg will be available as white round film coated tablets.
Intervention Type
Drug
Intervention Name(s)
Ketoconazole
Other Intervention Name(s)
SB773812
Intervention Description
Ketoconazole will be available as 200mg tablets.
Primary Outcome Measure Information:
Title
Blood sampling over period of 336 hours post dosing with SB-773812
Time Frame
over period of 336 hours post dosing
Secondary Outcome Measure Information:
Title
Safety: ECG, vital signs, adverse events, clinical labs over 48 hours post SB-773812 dosing.
Time Frame
over 48 hours post SB-773812 dosing.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
12. IPD Sharing Statement
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Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812
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