Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-31 @ 11:51 AM
Study NCT ID:
NCT00849134
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2009-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First Time in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food of Single Assending Doses of GSK1482160.
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A First-Time-in-Human Randomised, Single Blind Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics, of Single Escalating Doses of GSK1482160, in Male and Female Healthy Subjects, and to Make a Preliminary Assessment of the Effect of Food.
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 is a first-time-in-human study. The overall purpose of the study is to assess whether the drug is safe and well tolerated after single, increasing doses. At different doses, we will look to see how much of the drug gets into the bloodstream, how the drug is broken down and excreted and whether this is affected by the presence of food.
Detailed Description:
GSK1482160 is a new drug to be developed for treating inflammatory pain (for example, arthritis). It acts on structures on inflammatory cells, known as P2X7 receptors. Blocking these receptors reduces the release of important inflammatory chemicals which exists within the body and are thought to play an important role in promoting inflammatory pain.
This study will start with a very low dose of study drug, which will then be gradually increased in subsequent doses. This is known as dose-rising and is the way to assess safety and tolerability (any side effects that make taking the drug unpleasant). Effects will be compared to those seen when a placebo (a "dummy" drug) is taken. Up to 4 groups of 8 healthy male or female volunteers will be enrolled into the study. In addition, part of the study will be used to check if there is a difference in the blood levels of the study drug when taken with or without a high fat meal.
This study will start with a very low dose of study drug, which will then be gradually increased in subsequent doses. This is known as dose-rising and is the way to assess safety and tolerability (any side effects that make taking the drug unpleasant). Effects will be compared to those seen when a placebo (a "dummy" drug) is taken. Up to 4 groups of 8 healthy male or female volunteers will be enrolled into the study. In addition, part of the study will be used to check if there is a difference in the blood levels of the study drug when taken with or without a high fat meal.
Study Oversight
Has Oversight DMC:
False
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?: