LEO 158968 efficacy, safety, PK, and PD trial
Research type
Research Study
Full title
An Open-Label, Phase 1B, Multi-Site Trial to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics following a Single Dose of LEO 158968 in Subjects with Gout Flares
IRAS ID
1009613
Contact name
Jacob Müller
Contact email
Sponsor organisation
LEO Pharma A/S
Clinicaltrials.gov Identifier
Research summary
Why is this study needed?\nResearchers are looking for better treatments of several autoinflammatory diseases. LEO 158968 is a new compound.\n\nThe study will be conducted in patients with gout flares. A decrease in pain is expected to be seen in participants with gout flares when they are administered a single dose of LEO 158968. LEO 158968 has been administered to humans before. In addition, it has been extensively tested in the laboratory and on animals.\n\nWhat is the purpose of the study?\nThe main goal of this study is to investigate the effect of a single dose of LEO 158968 on pain. It will also be investigated how well LEO 158968 is tolerated and to what extent LEO 158968 is absorbed, distributed, metabolised, and eliminated from the body (this is called pharmacokinetics). In addition, the effect of LEO 158968 on specific compounds in the blood that are related to inflammation will be investigated (this is called pharmacodynamics). \n\nWhat will happen during the study?\nBecause the participants must be experiencing a gout flare at the time of dosing, they will be screened and will enter the trial within 96 hours after the onset of a gout flare. On the day of screening or the day thereafter, a single dose of LEO 158968 will be administered as injections under the skin of the abdomen. Participants will stay at the research site for at least 6 hours after dosing and then return to the research site on for four further clinic visits. \n\nPain intensity regarding the gout flares will be assessed using questionnaires at the research site and when at home.\nMedical examinations that will be performed include physical examinations, heart tracings, laboratory blood and urine tests, measurement of vital signs.
REC name
West of Scotland REC 1
REC reference
24/WS/0038
Date of REC Opinion
17 May 2024
REC opinion
Further Information Favourable Opinion