A Phase 1 interventional study of SB-751689 oral tablets (100 and 400 ng) and Ketoconazole (NIZORAL) oral tablets (200 mg) in Osteoporosis, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-10-13.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
This study will evaluate the safety, tolerability and exposure of SB-751689 when administered alone at supratherapeutic doses and when SB-751689 is co administered with ketoconazole, a PGP/CYP3A4 inhibitor that increases exposure of SB-751689. Data from this study will enable the planning and conduct of a QTc study for SB-751689.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 15 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Exclusion Criteria:
Also known as: SB-751689 oral tablets (100 and 400 ng)
Safety and tolerability of SB-751689 doses determined from clinical safety and tolerability data from all adverse event reporting, 12-lead ECGs, vital signs, nursing/physician observation, and safety laboratory tests
Time frame: throughout the study
PK and of SB-751689 as determined by AUC, Cmax, tmax, and half-life. PD effects (PTH, serum Ca) as determined by AUC, Emax, tmax, maximum change and % change from baseline, duration of effect, duration above ULN for PTH.
Time frame: throughout the study
This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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