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
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 schizophrenia
Started Oct 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 13, 2006
CompletedFirst Submitted
Initial submission to the registry
December 13, 2006
CompletedFirst Posted
Study publicly available on registry
December 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2007
CompletedAugust 3, 2017
August 1, 2017
12 months
December 13, 2006
August 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood sampling over period of 336 hours post dosing with SB-773812
over period of 336 hours post dosing
Secondary Outcomes (1)
Safety: ECG, vital signs, adverse events, clinical labs over 48 hours post SB-773812 dosing.
over 48 hours post SB-773812 dosing.
Study Arms (2)
Subjects receiving ketoconazole for 8 days
EXPERIMENTALIn 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
EXPERIMENTALIn 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.
Interventions
SB-773812 20 mg will be available as white round film coated tablets.
Ketoconazole will be available as 200mg tablets.
Eligibility Criteria
You may qualify if:
- Healthy
- Body Weight \>/=50kg and BMI 18.5-29.9 kg/m2 inclusive
- Normal 12-lead ECG, physical examination and lab screen
You may not qualify if:
- A history of psychiatric illness,
- A history or presence gastro-intestinal,
- A hepatic or renal disease or orthostatic hypotension.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Dundee, DD1 9SY, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2006
First Posted
December 15, 2006
Study Start
October 13, 2006
Primary Completion
October 10, 2007
Study Completion
October 10, 2007
Last Updated
August 3, 2017
Record last verified: 2017-08