GSK Investigational Site
Overland Park, Kansas, 66211, United States
NCT Number: NCT02169583
This will be the first time GSK1325756 Solution for Infusion formulation that has been administered to humans. Prior studies have been performed with oral GSK1325756. The primary objectives of this study are to obtain information on the safety, tolerability, and pharmacokinetics (PK) of single and twice daily intravenous (IV) administration of GSK1325756 in healthy subjects. In Part A, single, escalating doses will be given in the same cohort of subjects after a seven day washout. In addition, the study will evaluate the absolute bioavailability of a single dose of the current oral tablet formulation as compared to the IV formulation in Part A. In Part B, twice daily (BID) intravenous dose administration will be given for 5 days (9 total doses) in two separate cohorts of subjects. Data from this study will provide understanding of the safety, tolerability, and PK of intravenously administered GSK1325756 twice daily to guide dose selection in future clinical studies in patients with viral respiratory tract infections
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Overland Park, Kansas, 66211, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Solution containing 2 mg/mL GSK1325756 in sterile water for injection, to be administered intravenously.
Solution containing sterile water for injection matching GSK1325756 solution, to be administered intravenously.
A white film coated tablet containing 50 mg GSK1325756 to be administered orally.
A white film coated tablet matching GSK1325756 tablet, to be administered orally.
Time frame: Part A and Part B: from Day -1 until 7 to 10 days post-last dose
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Time frame: Part A and Part B: from Day -1 until 7 to 10 days post-last dose
Clinical laboratory assessments will include hematology, clinical chemistry, urinalysis parameters
Time frame: Part A and Part B: from Day -1 until 7 to 10 days post-last dose
Vital sign measurements will include systolic and diastolic blood pressure and pulse rate
Time frame: Part A and Part B: from Day -1 until 7 to 10 days post-last dose
12-lead ECGs will be obtained at each timepoint
Time frame: Part A: Pre-dose, 0.5 hour (hr), 1hr (end of infusion/post oral dose), 1.5, 2, 3, 4, 8, 12, 24hrs post-dose in each treatment period.
PK parameters will include area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)], area under the concentration-time curve from time zero (pre-dose) to time t [AUC(0-t)], area under the concentration-time curve from time zero (pre-dose) to 24 hours [AUC(0-24)], maximum observed concentration (Cmax), time to maximum observed concentration (tmax), observed concentration at 24 hours post-dose (C24), terminal half-life (t1/2), time of last measurable concentration (tlast), clearance (CL) and volume of distribution (Vz)
Time frame: Part B: Day 5 at pre-dose, 0.5, 1hr (end of infusion), 1.5, 2, 3, 4, 8, 12 and 24 hrs post-dose
PK parameters will include area under the concentration-time curve from time zero (pre-dose) to the end of the dosing interval [AUC(0-tau)], concentration at the end of the dosing interval (Ctau), Cmax, tmax, t1/2, Volume of distribution at steady-state (Vdss), and oral clearance (CL/F)
Time frame: Part A: Pre-dose, 0.5hr, 1hr (end of infusion/post oral dose), 1.5, 2, 3, 4, 8, 12, 24hrs post-dose. Part B: Day 1 and Day 5: pre-dose, 0.5, 1hr (end of infusion), 1.5, 2, 3, 4, 8, 12 and (Day 5 only) 24 hrs post-dose. Day 2-4: pre-dose (each dose)
PK parameters will include AUC(0-infinity), AUC(0-t), Cmax, and C24 following single IV dose administration (Part A) and AUC(0-tau), Ctau, and Cmax following repeated IV dose administration (Part B)
Time frame: Part A: Pre-dose, 0.5hr, 1hr (end of infusion/post oral dose), 1.5, 2, 3, 4, 8, 12, 24hrs post-dose
PK parameters will include AUC(0-infinity), AUC(0-t), Cmax and tmax
Time frame: Part A: Pre-dose, 0.5hr, 1hr (end of infusion/post oral dose), 1.5, 2, 3, 4, 8, 12, 24hrs post-dose Part B: Day 1 and Day 5: pre-dose, 0.5, 1hr (end of infusion), 1.5, 2, 3, 4, 8, 12 and (Day 5 only) 24 hrs post-dose. Day 2-4: pre-dose (each dose)
GSK1325756 AUC(0-tau), Cmax, and Ctau on the last day of dosing will be compared to area under the concentration-time curve from time zero (pre-dose) to 12 hours [AUC(0-12)], Cmax, and observed concentration at 12 hours post-dose (C12) on Day 1 to estimate accumulation ratio
Time frame: Part A: Pre-dose, 0.5hr, 1hr (end of infusion/post oral dose), 1.5, 2, 3, 4, 8, 12, 24hrs post-dose Part B: Day 1 and Day 5: pre-dose, 0.5, 1hr (end of infusion), 1.5, 2, 3, 4, 8, 12 and (Day 5 only) 24 hrs post-dose. Day 2-4: pre-dose (each dose)
GSK1325756 AUC(0-tau) on the last day of dosing in Part B, will be compared to AUC(0-infinity) on Day 1 of Part A to evaluate time invariance
Time frame: Part B: Day 2 to Day 4 (pre-dose; each dose)
GSK1325756 Pre-dose concentrations on Day 2 through 4 will be used to assess the achievement of steady state of GSK1325756 following repeat administration (Part B)
Time frame: Part A and Part B: from Day -1 until 7 to 10 days post-last dose
GlaxoSmithKline
Industry
A Two Part, Phase I, Randomized, Placebo Controlled, Double Blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Escalating Doses of GSK1325756 Solution for Infusion, and Absolute Bioavailability Relative of an Oral Dose, in Healthy Adult Subjects Protocol 201022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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