A Phase 1 interventional study of GSK1247303 in Healthy Subjects, sponsored by GlaxoSmithKline. Terminated at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-10-19.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
To determine safety, tolerability and Pharmacokinetics of GSK1247303
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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Note: 1 drink is equivalent to 12 g alcohol = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.
safety (adverse events, laboratory, ECG and vital signs assessments) and plasma pharmacokinetics of single and repeat doses of GSK1247303
Day 10 GSK1247303 AUC(0-t) compared to AUC(0-12) and/or AUC(0-24) on Day 1 to estimate accumulation ratio (R) and GSK1247303 AUC(0-t) on Day 10 compared to AUC on Day 1 to evaluate time invariance following repeat administration of GSK1247303.
Time frame: day 1 and day 10
Pre-morning dose concentrations (Ct) on Day 2 through 10 to assess the achievement of steady state of GSK1247303 following repeat administration.
Time frame: Day 2 through 10
GSK1247303 PK parameters: AUC(0-t), AUC(0-t), Cmax, and C12 and/or C24 following single dose administration and AUC(0-t), Ct, Cmin, and Cmax following repeat administration at different doses for the assessment of dose proportionality.
This study is terminated, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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