A study to assess the safety, processing by the body, and effects on the body following 4 weeks of selnoflast dosing in participants with coronary artery disease

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2022
INTERVENTION: The participants in the parent study and sub‐study will be divided in the following two treatment arms: 1. Selnoflast: Participants will receive selnoflast capsules, orally, twice daily (BID), from Day 1 to Day 28 2. Placebo: Participants will receive selnoflast matching placebo capsules, orally, BID, from Day 1 to Day 28 CONDITION: Coronary artery disease ; Circulatory System PRIMARY OUTCOME: 1. Percentage of participants with adverse events (AEs) measured from screening up to 28 days after the final dose of study drug (up to day 56); 2. Percentage of participants with severity of AEs determined according to the National Cancer Institute common terminology criteria for adverse events version 5.0 (NCI CTCAE v5.0) grading scale measured from screening up to 28 days after the final dose of study drug (up to day 56); 3. Percentage of participants with clinically significant changes in vital sign values measured using respiratory rate, pulse rate, systolic and diastolic blood pressure and temperature measured from screening up to 28 days after the final dose of study drug (up to day 56); 4. Percentage of participants with clinically significant abnormalities in electrocardiogram (ECG) parameters Measured Using Single 12‐Lead ECG from screening up to 28 days after the final dose of study drug (up to day 56); 5. Percentage of participants with clinically significant laboratory findings measured using blood and urine samples from screening up to 28 days after the final dose of study drug (up to day 56) SECONDARY OUTCOME: 1. Plasma concentration of selnoflast and its metabolites, if applicable, measured using plasma samples collected at specified timepoints (pre‐dose and post‐dose) from day 1 to day 29; 2. Change From baseline in hsCRP measured using blood samples collected at specified timepoints from screening up to 28 days after the final dose of study drug (up to day 56) INCLUSION CRITERIA: 1. Aged 18 years and over at the time of signing Informed Consent Form 2. A diagnosis of stable CAD with a history of myocardial infarction (MI) (known or suspected to be atherothrombotic Type 1) at least 90 days prior to screening Visit 1. Sub‐study participants may have coronary revascularization at least 90 days prior to screening visit 1 and within 10 years of screening visit 1 3. Elevated plasma hsCRP level of = 2 mg/l at screening visit 1 and 2 4. QTcF = 450 ms in men and = 470 ms in women by a single 12‐lead ECG recording 5. Participants with CAD, pathogenic TET2 mutation(s) indicating a variant allele frequency (VAF) > 2% indicative of CHIP, and elevated hsCRP will be enrolled in the sub‐study
Epistemonikos ID: a6a6db20a0ee1f95fa6fc534ad048bb21f7ef3ba
First added on: Jul 06, 2022