NCT00387413

A Study Of GSK189254 And Duloxetine In The Electrical Hyperalgesia Model Of Healthy Volunteers

Completed Phase 1 Last updated 7 August 2017

What this trial tests

Phase 1 trial testing Duloxetine in Hyperalgesia in 40 participants. Completed in 31 May 2007.

Timeline

2 October 2006

Primary endpoint
31 May 2007

31 May 2007

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Primary purpose	treatment
Enrollment	40
Start date	2 October 2006
Primary completion	31 May 2007
Estimated completion	31 May 2007
Sites	1 location across United Kingdom

Drugs / interventions tested

• Duloxetine (duloxetine) — full drug profile →
• GSK189254 — full drug profile →
• GSK189254 Placebo — full drug profile →
• Duloxetine Placebo — full drug profile →

Conditions studied

• Hyperalgesia — all drugs for Hyperalgesia →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 45, any sex, with Hyperalgesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

GSK189254 is a highly potent histamine 3 (H3) receptor antagonist which has demonstrated efficacy in the reduction of mechanical hyperalgesia and allodynia in the chronic constriction injury pre-clinical model of neuropathic pain (NP). The mechanism of action of GSK 189254 in the pain model is hypothesised to be via enhanced release of monoamines in the central nervous system (CNS). A similar mechanism of action has also been shown for duloxetine. In this phase I study, the safety and efficacy of GSK189254 will be investigated in the electrical hyperalgesia (EH) model in healthy volunteers to build confidence that the preclinical efficacy demonstrated by this compound will translate into patients.

This study will be conducted as a double-blind, double-dummy, placebo-controlled, incomplete block, two period crossover study. Up to 40 healthy male or female volunteers, aged 18-45 years old, will be randomised into the study in order to achieve 32 evaluable subjects. Subjects will undergo two 3-week treatment periods and will be randomised to receive placebo and either GSK189254 (up to 100µg once daily) or duloxetine (up to 60mg daily). There will be a one week washout between treatment periods. The effects of repeated oral dosing of GSK189254 and duloxetine on secondary hyperalgesia in the EH model will be determined. Subject: GSK189254, Neuropathic pain (NP), H3 antagonist, duloxetine, Electrical hyperalgesia, Phase I, Healthy volunteers, Double blind, Safety, tolerability.

Publications & conference data

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

1. Histamine pharmacology and new CNS drug targets.
   Tiligada E, Kyriakidis K, Chazot PL, Passani MB. · · 2011 · cited 73× · PMID 22070192 · DOI 10.1111/j.1755-5949.2010.00212.x
2. Targeting Microglia in Neuroinflammation: H3 Receptor Antagonists as a Novel Therapeutic Approach for Alzheimer's Disease, Parkinson's Disease, and Autism Spectrum Disorder.
   Thomas SD, Abdalla S, Eissa N, Akour A, et al · · 2024 · cited 18× · PMID 39065682 · DOI 10.3390/ph17070831