A Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C -GSK1322322 After an Intravenous and an Oral Dose
This is a phase 1, non-randomized, open label, single-dose, two-period, cross-over study. This study will utilize 14C radiolabeled GSK1322322 to investigate the recovery, excretion, and pharmacokinetics of GSK1322322 in 6 healthy adult male subjects through the sampling of blood, urine, and feces.
Each subject will participate in the study for approximately 7 to 8 weeks i.e., 30 day screening period, two dosing periods (approximately 8 days each) and a follow up visit.
The subjects will be admitted to the clinical unit on Day 1 of the first treatment period and remain in the unit for up to approximately 16 days through the end of the second treatment period.
On Day 1 of Period 1, each subject will receive 14C radiolabeled GSK1322322 as a single therapeutic intravenous (IV) dose (1000 milligrams [mg]). When the total radioactivity is <1% of the administered dose in all subjects, Period 2 dosing will begin (approximately 8 days after the IV dose). On Day 1 of Period 2, each subject will receive single therapeutic oral solution dose (1200 mg). Blood, urine, bile and fecal samples will be collected during both the periods. The subject may be discharged from the unit as early as Day 8 of Period 2. Subjects will visit the study unit for the follow-up visit 7 to 10 days following discharge from the unit.
|Infections, Bacterial||Drug: GSK1322322 1000 mg containing radioactive 14C-GSK1322322 Drug: GSK1322322 1200 mg containing radioactive 14C-GSK1322322||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||An Open Label, Non-Randomized, Single Dose, Two Period, Cross-Over, Mass Balance Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C -GSK1322322 Administered as a Single Intravenous and Single Oral Dose to Healthy Adult Male Subjects|
- 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 [ Time Frame: 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 [ Time Frame: 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)
- Safety parameters including adverse events, clinical laboratory tests, concomitant medications, electrocardiograms, and vital signs [ Time Frame: Duration of the study (56 days) ]To evaluate the safety and tolerability of GSK1322322 after single IV and oral solution doses in healthy subjects safety parameters will be analyzed.
|Actual Study Start Date:||August 10, 2012|
|Study Completion Date:||October 5, 2012|
|Primary Completion Date:||October 5, 2012 (Final data collection date for primary outcome measure)|
Experimental: GSK1322322 1000 mg IV
On 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.
Drug: GSK1322322 1000 mg containing radioactive 14C-GSK1322322
GSK1322322 1000 mg is a mesylate salt powder for injection containing 45.5 μCi radioactive 14C-GSK1322322 1000 mg as free base.
Experimental: GSK1322322 1200 mg Oral Solution
On 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).
Drug: GSK1322322 1200 mg containing radioactive 14C-GSK1322322
GSK1322322 1200 mg is a mesylate salt powder for oral solution containing 54.5 μCi radioactive 14C-GSK1322322 1200 mg as free base.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663389
|United States, Minnesota|
|GSK Investigational Site|
|Minneapolis, Minnesota, United States, 55404|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|