Ignite Creation Date:
2024-05-06 @ 9:19 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02953808
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2016-11-01
Brief Title:
Phase 1 Study of GSK2315698 in Healthy Japanese Subjects
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Single Centre Double-blind Randomised Placebo-controlled and Single Dose-ascending Study to Investigate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Single Intravenous Doses of GSK2315698 in Healthy Japanese Subjects
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is the first study in which GSK2315698 will be administered in Japanese population The primary objective of the study is to investigate safety and tolerability pharmacokinetics and pharmacodynamics after single intravenous infusion in healthy subjects This will be a single center double-blind randomized placebo-controlled dose-ascending study
Subjects in Cohort 1 will attend 3 dosing sessions and will be randomized to one of the 3 groups Each group will receive GSK2315698 and Placebo in a defined sequence The dose levels of GSK2315698 are set to 10 milligrams mg per hour hr 20 mghr and 40 mghr to be administered over 1 hour Dosing sessions 1 and 2 and dosing sessions 2 and 3 will be separated by a washout period of at least 8 and 10 days respectively
Subjects in Cohort 2 will attend a single dosing session and will be randomized to receive either GSK2315698 20 mghr or Placebo over a period of 15 hours
A sufficient number of subjects will be randomized such that 18 subjects 9 in each cohort complete the study The duration of participation for any subject in this study will be approximately 59 days
Subjects in Cohort 1 will attend 3 dosing sessions and will be randomized to one of the 3 groups Each group will receive GSK2315698 and Placebo in a defined sequence The dose levels of GSK2315698 are set to 10 milligrams mg per hour hr 20 mghr and 40 mghr to be administered over 1 hour Dosing sessions 1 and 2 and dosing sessions 2 and 3 will be separated by a washout period of at least 8 and 10 days respectively
Subjects in Cohort 2 will attend a single dosing session and will be randomized to receive either GSK2315698 20 mghr or Placebo over a period of 15 hours
A sufficient number of subjects will be randomized such that 18 subjects 9 in each cohort complete the study The duration of participation for any subject in this study will be approximately 59 days
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None