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

NCT04114656 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-03-18

Study results available
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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

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2021-09-16
Completion
2021-09-16

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04114656 on ClinicalTrials.gov