Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: SB773812 (Drug); Ketoconazole (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MBChB, DA(SA), Dip Pharm Med, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole 400mg on Pharmacokinetics of SB-773812 20mg.
Study design: Diagnostic, Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Primary outcome: Blood sampling over period of 336 hours post dosing with SB-773812
Secondary outcome: Safety: ECG, vital signs, adverse events, clinical labs over 48 hours post SB-773812 dosing.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
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.
Locations and Contacts
GSK Clinical Trials Call Center, Dundee DD3 8EA, United Kingdom; Recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
Additional Information
Starting date: October 2006
Last updated: August 17, 2007
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