Phase I Crossover Study to Investigate the Effects of RIST4721

• Research type

  Research Study

• Full title

  A Randomised, Single-Blind, Placebo-Controlled Crossover Study to Investigate the Effects of RIST4721, a Novel CXCR2 Inhibitor, on the Inflammatory Response in Healthy Male Subjects Using a Standardized Blister Model

• IRAS ID

  264859

• Contact name

  Robert Greenhalgh

• Contact email

  robertgreenhalgh@macplc.com

• Sponsor organisation

  Aristea Therapeutics

• Eudract number

  2019-001713-16

• Clinicaltrials.gov Identifier

  NCT04105959

• Duration of Study in the UK

  0 years, 3 months, 30 days

• Research summary

  The purpose of this study is to test a drug called RIST4721, that is being developed for the treatment of diseases where there is inflammation. Participation will last approximately 11 weeks and participants will attend for study visits on 14 occasions, at the MAC Clinical Research Unit.

  Inflammation occurs naturally in response to the body being injured, infected or whilst healing. In some cases, the body triggers an inflammatory response when it is not required, such as conditions like arthritis or inflammation of the bowel. The study drug works by blocking chemicals that trigger an inflammatory response.

  Two different techniques to make a blister have been proposed:

  •The cantharidin-induced blister model involves the application of a substance called cantharidin (which is sometimes used as a treatment for warts) to the skin, causing a blister to form.
  •The suction-induced blister model involves a suction pump being applied to the skin which acts as a vacuum and pulls the top layer of the skin away, causing a blister to form.

  Only one of the methods will be selected and will be decided prior to the study start. The main aims are:

  •To see the effect of the study drug on markers of inflammation in blister fluid.
  •To assess the safety of the study drug and any side effects.
  •To see the relationship between the amount of study drug in the blood and the effect on markers of inflammation in blister fluid and blood.

  It is planned to enrol 32 healthy male subjects. Subjects will take part in 2 treatment periods, in which they will be randomised to receive either RIST4721 (150 mg or 300 mg) in Treatment Period 1 and placebo in Treatment Period 2, or placebo in Treatment Period 1 and RIST4721 (150 mg or 300 mg) in Treatment Period 2.

• REC name

  Wales REC 1

• REC reference

  19/WA/0135

• Date of REC Opinion

  9 May 2019

• REC opinion

  Favourable Opinion