NCT04114656

Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Volunteers

A Randomized, Double-blind, Placebo-controlled, Three-period Two-treatment Incomplete-block Crossover Study to Investigate the Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Participants

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the mechanistic basis for the analgesic effects of GSK3858279 in humans by using a battery of experimental pain assessments in healthy participants. This will be placebo-controlled, three-period two-treatment crossover study. In each period, participants will receive either GSK3858279 or placebo in a 1:1 ratio. Only healthy male participants will be enrolled into the study. The duration of the study will be approximately 6 months.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Placebo	Placebo will be available as intravenous (IV) infusion of normal saline (0.9 percent \[%\] sodium chloride solution).
DRUG	GSK3858279	GSK3858279 will be available as IV infusion and the dose level to be administered is 3 milligrams (mg) per kilogram (kg).

Timeline

• Start date: 2019-10-15
• Primary completion: 2021-09-16
• Completion: 2021-09-16
• First posted: 2019-10-03
• Last updated: 2024-03-18
• Results posted: 2023-08-01

Locations

1 site across 1 country: Netherlands