Ignite Creation Date:
2024-05-06 @ 12:44 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01648192
Status:
COMPLETED
Last Update Posted:
2017-07-26
First Post:
2012-07-12
Brief Title:
Phase I Study of GW856553 Losmapimod
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase I Randomized Single-Blind Three-Period Cross-Over Placebo-Controlled Single Oral Dose Dose-Escalation Part 1 Fixed Sequence and Repeat Dose Part 2 Study to Evaluate the Safety Pharmacokinetics and Pharmacodynamics of Losmapimod in Healthy Japanese Subjects
Status:
COMPLETED
Status Verified Date:
2017-07
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 study is the first study of losmapimod in Japanese subjects This study will be a single-center single blind phase I and two part study to characterize the safety tolerability pharmacokinetic and pharmacodynamic profiles in healthy Japanese volunteers male and female of non-childbearing potential Part1 will be a single dose randomized three-period placebo-controlled and dose escalation part Each subject will participate in 3 dosing sessions and receive on separate days three of four treatments of losmapimod 25 75 and 20 mg and the matching placebo in the fasted state after overnight fast at least 10 hours The design incorporates sufficient washout between treatments at least 7 days after the previous administration and is an efficient design for the study objectives Part 2 will be a fixed dose and placebo-controlled part Each subject will participate in one dosing session and receive losmapimod 75 mg or the matching placebo twice daily in the fasted state for 14 days Only subjects will be blind to the sequence and dose studied The study will include the placebo treatment to allow a valid evaluation of adverse events attributable to treatment versus those independent of treatment Approximately 18 subjects in each part will receive treatments of losmapimod andor placebo in the design The primary objective of the study is to characterize the safety and tolerability of single doses and repeat doses of losmapimod in healthy Japanese subjects Serial pharmacokinetic samples will be collected and safety assessments will be performed following each dose
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