Table 3.
Demographics of healthy volunteers (pharmacokinetic analysis set) in five phase I studies investigating the potential for drug–drug interactions (DDIs) of vericiguat with drugs prescribed in cardiovascular disease or acting on the nitric oxide signaling pathway
| Characteristic | DDI with warfarin | DDI with digoxin | DDI with aspirin (main part) | DDI with sacubitril/valsartan | DDI with sildenafil | ||
|---|---|---|---|---|---|---|---|
| (n = 23) | (n = 25) | (n = 14) | (n = 15; PKS1a) | (n = 14; PKS2b) | (n = 16; PKS1a) | (n = 32; PKS2b) | |
| Male, n (%) | 23 (100) | 25 (100) | 14 (100) | 15 (100) | 14 (100) | 16 (100) | 32 (100) |
| White, n (%) | 23 (100) | 25 (100) | 14 (100) | 15 (100) | 14 (100) | 16 (100) | 32 (100) |
| Age range criterion, years (inclusive) | 18–55 | 18–55 | 18–45 | 40–60 | 40–60 | 40–60 | 40–60 |
| Weight range, kg | 62.1–98.2 | 54.3–95.5 | 63–93 | 67.3–96.0 | 67.3–96.0 | 61.4–93.5 | 61.4–101.4 |
| Height range, cm | 164–188 | 162–189 | 163–186 | 165.0–186.0 | 165.0–186.0 | 168.0–188.0 | 168.0–191.0 |
| BMI range, kg/m2 | 20.5–29.0 | 20.1–29.8 | 21.6–28.7 | 21.5–29.2 | 21.5–28.1 | 21.4–29.1 | 21.2–29.5 |
Values are range (minimum–maximum) unless stated otherwise
BMI body mass index, PKS pharmacokinetic set
aPopulation used for the analysis of the victim potential of vericiguat with co-medication
bPopulation used for the analysis of the perpetrator potential of vericiguat with co-medication