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
- Conditions
- Coronary artery diseaseCirculatory System
- Registration Number
- ISRCTN10520571
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 60
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
1. Individuals with Class III and IV heart failure According to New York Heart Association
2. Planned procedure or surgery during the study and any major surgery within 90 days prior to screening Visit 1
3. Treatment with a live, attenuated vaccine within 90 days prior to the randomization visit
4. Treatment with a COVID-19 vaccine (including boosters) or other non-live vaccines (e.g., flu) within 28 days prior to the randomization visit
5. Current treatment with medications that are well known to prolong the QT interval or a known history of long QT syndrome or torsade de pointes
6. Positive hepatitis C virus (HCV) antibody test and subsequent positive HCV RNA test at screening
7. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) test at screening
8. Positive human immunodeficiency virus (HIV) tests (HIV-1 antibody, HIV-1/2 antibody, HIV-2 antibody) at screening
9. History of tuberculosis or a positive interferon-? (IFN-?) release test at screening
10. Uncontrolled hypertension, defined as an average systolic blood pressure > 160 mmHg or an average diastolic blood pressure > 100 mmHg at each screening visit
11. Prior malignancy other than basal cell skin carcinoma, fully excised squamous cell carcinoma, and cervical intraepithelial neoplasia
12. Poor peripheral venous access
13. Uncontrolled cardiac arrhythmia, defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, within 90 days prior to randomization
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method