NCT00849134

First Time in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food of Single Assending Doses of GSK1482160.

Completed Phase 1 Last updated 7 July 2017

What this trial tests

Phase 1 trial testing GSK1482160 or placebo in Pain, Inflammatory in 25 participants. Completed in 6 April 2009.

Timeline

17 November 2008

Primary endpoint
6 April 2009

6 April 2009

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	25
Start date	17 November 2008
Primary completion	6 April 2009
Estimated completion	6 April 2009
Sites	1 location across United Kingdom

Drugs / interventions tested

• GSK1482160 or placebo — full drug profile →

Conditions studied

• Pain, Inflammatory — all drugs for Pain, Inflammatory →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 55, any sex, with Pain, Inflammatory. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treating inflammation by blocking interleukin-1 in a broad spectrum of diseases.
   Dinarello CA, Simon A, van der Meer JW. · · 2012 · cited 1387× · PMID 22850787 · DOI 10.1038/nrd3800
2. Targeting the NLRP3 inflammasome in chronic inflammatory diseases: current perspectives.
   Ozaki E, Campbell M, Doyle SL. · · 2015 · cited 305× · PMID 25653548 · DOI 10.2147/jir.s51250
3. A potential therapeutic role for P2X7 receptor (P2X7R) antagonists in the treatment of inflammatory diseases.
   Arulkumaran N, Unwin RJ, Tam FW. · · 2011 · cited 201× · PMID 21510825 · DOI 10.1517/13543784.2011.578068
4. Molecular and functional properties of P2X receptors--recent progress and persisting challenges.
   Kaczmarek-Hájek K, Lörinczi E, Hausmann R, Nicke A. · · 2012 · cited 177× · PMID 22547202 · DOI 10.1007/s11302-012-9314-7
5. P2X7 in Cancer: From Molecular Mechanisms to Therapeutics.
   Lara R, Adinolfi E, Harwood CA, Philpott M, et al · · 2020 · cited 136× · PMID 32581786 · DOI 10.3389/fphar.2020.00793
6. The Purinergic System as a Pharmacological Target for the Treatment of Immune-Mediated Inflammatory Diseases.
   Antonioli L, Blandizzi C, Pacher P, Haskó G. · · 2019 · cited 126× · PMID 31235653 · DOI 10.1124/pr.117.014878
7. The Role of Purinergic P2X7 Receptor in Inflammation and Cancer: Novel Molecular Insights and Clinical Applications.
   Rotondo JC, Mazziotta C, Lanzillotti C, Stefani C, et al · · 2022 · cited 66× · PMID 35267424 · DOI 10.3390/cancers14051116
8. Role of NLRP3 Inflammasome in Parkinson's Disease and Therapeutic Considerations.
   Nguyen LTN, Nguyen HD, Kim YJ, Nguyen TT, et al · · 2022 · cited 57× · PMID 35988226 · DOI 10.3233/jpd-223290