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GSK1322322 containing radioactive 14C-GSK1322322

Phase 1

Infections, Bacterial | Small molecule | Infectious Disease |GSK plc|Last Updated: Jun 12, 2017

Success Probability

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment5

FDA Designations

No designations recorded

Clinical trial landscape

GSK1322322 containing radioactive 14C-GSK1322322 · 1 trial · 1 indication

Phase 1 1
NCT01663389A Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C -GSK1322322 After an Intravenous and an Oral DoseInfections, Bacterial
COMPLETED5 Analytics
PHASE1COMPLETED
A Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C -GSK1322322 After an Intravenous and an Oral Dose
Infections, Bacterial
NCT016633895
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Study Endpoints

Primary Endpoints

Plasma pharmacokinetic (PK) parameters of GSK1322322 and radiolabeled compound following single IV or oral solution dose: AUC(0-infinity), AUC(0-t), Cmax, tmax, t1/2 for IV and oral solution regimens and CL and Vss for IV regimen only
Day 1 through Day 8 of Period 1 and Period 2 (16 days)

Plasma PK parameters will be statistically summarized by treatment. Plasma concentration-time data will be analyzed by non-compartmental methods. Following PK parameters will be studied: Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time \[AUC(0-infinity)\], AUC(0-t), maximum observed concentration (Cmax), time of occurrence of Cmax (tmax), terminal phase half-life (t1/2) for IV and oral solution regimens and systemic clearance (CL) and volume of distribution (Vss) for IV regimen only.

Percent total recovery of radioactivity in urine and feces in each interval and cumulative
Day 1 through Day 8 (and additional days, if required) of Period 1 and Period 2 (16 days or more)

Total recovery of radioactivity in urine and feces (as a percentage of total radioactive dose in each interval and cumulative)

Secondary Endpoints

Safety parameters including adverse events, clinical laboratory tests, concomitant medications, electrocardiograms, and vital signs
Duration of the study (56 days)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GSK1322322 1000 mg IVEXPERIMENTALOn Day 1 of Period 1, after an overnight fast, subjects will receive GSK1322322 1000 mg IV single dose (containing approximately 45.5 microcurie \[μCi\] radioactive 14C-GSK1322322) for intravenous infusion over 60 minutes.
GSK1322322 1200 mg Oral SolutionEXPERIMENTALOn Day 1 of Period 2, after an overnight fast, subjects will receive GSK1322322 1200 mg oral solution single dose (containing approximately 54.5 μCi radioactive 14C-GSK1322322).

Interventions

NameTypeDescription
GSK1322322 1000 mg containing radioactive 14C-GSK1322322DRUGGSK1322322 1000 mg is a mesylate salt powder for injection containing 45.5 μCi radioactive 14C-GSK1322322 1000 mg as free base.
GSK1322322 1200 mg containing radioactive 14C-GSK1322322DRUGGSK1322322 1200 mg is a mesylate salt powder for oral solution containing 54.5 μCi radioactive 14C-GSK1322322 1200 mg as free base.
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Eligibility Criteria

Age Range30 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects between 30 and 55 years of age, with body weight between 60 to 80 kilograms (kg) and a history of regular bowel movements * Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods from first dose of...

Countries:United States
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