A Phase Ic Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics Following 4 Weeks of NLRP3 Inhibition With Selnoflast in Participants With Coronary Artery Disease

  • Coronary artery disease
Trial Status:

Not yet recruiting

This trial runs in
Countries
  • United States
Trial Identifier:

GC43343

      Show trial locations

      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics Following 4 Weeks of Nucleotide-binding Domain-like Receptor Protein 3 (NLRP3) Inhibition With Selnoflast in Participants With Coronary Artery Disease

      F. Hoffmann-La Roche Ltd (USA) Sponsor
      Phase 1 Phase
      GC43343 Trial Identifier
      Both Gender
      Above 18 Years Age
      No Healthy Volunteers

      Background and study aims:

      Coronary artery disease (CAD) is a form of heart (cardiovascular) disease that is caused by a buildup of plaque in the blood vessels (arteries) that provide blood to the heart and body. Research has suggested that swelling (inflammation) may play a role in CAD and that blocking the inflammation causing factors could be helpful. Selnoflast is an experimental drug and is not yet approved by the health authorities. It is a drug that is being developed to lower inflammation in patients with CAD.

      Selnoflast will be tested in a parent study as well as a sub-study both enrolling different participants. The purpose of this study and sub-study is to compare the effects, good or bad, of selnoflast versus medication that looks like a drug but has no active ingredient (placebo) in participants with CAD and high levels of C reactive protein (CRP). Participants with alteration (mutation) of the diseased tet methylcytosine dioxygenase 2 (TET2) gene that causes an age-related blood cells disorder (clonal hematopoiesis of indeterminate potential [CHIP]), in addition to narrowing of the blood vessels of the heart (CAD) and elevated CRP, will be enrolled in the sub-study. CRP is a protein indicative of inflammation in the body, it can be measured in blood by a routine laboratory test.

      Who can participate?

      People who are 18 years and above, diagnosed with coronary artery disease

      What does the study involve?

      Participants will be a part of either the parent study or the sub-study for a total of three months respectively.

      Both these studies will be conducted in three parts:

      1. Screening Period: Participants will have to undergo certain test to see if they are eligible to participate in the study. There will be two screening visits 4 weeks before start of the study

      2. Treatment Period: Participants will receive either selnoflast (study drug) or placebo once in the morning and once in the evening during the treatment period. The two doses must be taken not more than 14 hours apart. The participants will have to visit the clinic on Days 1, 8, 15, 22 to receive the study drug. On Days 1 and 15, participants will have to fast for at least 2 hours before receiving the drug. Participants in the sub-study will not have the requirement to fast before receiving the study drug. Participants can also consent for a Day 2 clinic visit in the parent study. Sub-study participants will not have the optional Day 2 clinic visit. Each visit may last for 2 to 6 hours. During the rest of the days, participants will self-administer the drug at home and maintain a record of the at-home dosing times in a paper diary.

      3. Follow-up Period: Participants will have to visit the clinic on Days 29, 35, 42, 49 and 56 for follow up visits. These visits will be to check on the participant after completion of the study treatment.

      The participants in the parent study and sub-study will be divided into two groups decided by chance. Participants will have a one in two chance of being placed in either group.

      • Group 1: Participants will receive selnoflast, given as pills to be taken by mouth twice a day for about 28 days
      • Group 2: Participants will receive placebo, given as pills to be taken by mouth twice a day for about 28 days

      What are the possible benefits and risks of participating?

      Participants may or may not receive any benefit from the study drug, but the information that is learned may help other people who have a similar medical condition in the future. Participants might experience side effects which can be mild to severe and vary from person to person. Selnoflast is an experimental drug and has limited testing in humans there may be side effects that are not known or expected at this time. The known and potential side effects of this drug are listed below:

      • Allergic Reactions: Allergic reactions can happen with any drug. These can be in the form of itching, difficulty breathing, a rash, and/or drop in blood pressure.
      • The most common side effects observed in the study conducted in healthy volunteers were mild headache and nausea
      • Infection: Selnoflast affects a protein that regulates the immune system. Inhibition of the immune system could result in increased likelihood of getting an infection.
      • Liver Damage: There may be some mild increase in laboratory tests used to evaluate liver function. Participants who have an abnormal blood test of liver function, will not be included in this study.
      • Decrease in the Effect of Vaccines: A protein (NLRP3) is activated by many vaccines. NLRP3 makes sure that the immune system responds properly to the vaccination. Hence, if NLRP3 is blocked the response to a vaccination can be weakened. Therefore, it is possible that the participants response to vaccination could be reduced when they are being treated with selnoflast.

      There may be a risk in exposing an unborn child to study drug, and all risks are not known at this time. Women who are pregnant, become pregnant, or are currently breastfeeding must take precautions to avoid exposing an unborn child to study drug.

      Trial Summary

      A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics Following 4 Weeks of Nucleotide-binding Domain-like Receptor Protein 3 (NLRP3) Inhibition With Selnoflast in Participants With Coronary Artery Disease

      F. Hoffmann-La Roche Ltd (USA) Sponsor
      Phase 1 Phase
      GC43343 Trial Identifier
      Selnoflast Treatments
      Coronary artery disease Condition
      Official Title

      A Phase Ic Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics Following 4 Weeks of NLRP3 Inhibition With Selnoflast in Participants With Coronary Artery Disease

      Eligibility Criteria

      Both Gender
      Above 18 Years Age
      No Healthy Volunteers

      Clinical Research Explained

      Information about what clinical trials and observational studies are. Understand why you might want to take part in clinical research and why diversity in clinical research is important.

      Find out now