NCT02169583

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Infections, Respiratory Tract

Interventions

Type	Name	Description
DRUG	GSK1325756 Solution	Solution containing 2 mg/mL GSK1325756 in sterile water for injection, to be administered intravenously.
DRUG	GSK1325756 Solution Matching Placebo	Solution containing sterile water for injection matching GSK1325756 solution, to be administered intravenously.
DRUG	GSK1325756 Tablet	A white film coated tablet containing 50 mg GSK1325756 to be administered orally.
DRUG	GSK1325756 Tablet Matching Placebo	A white film coated tablet matching GSK1325756 tablet, to be administered orally.

Timeline

• Start date: 2014-06-12
• Primary completion: 2014-08-28
• Completion: 2014-08-28
• First posted: 2014-06-23
• Last updated: 2017-05-15

Locations

1 site across 1 country: United States