There is one clinical trial.
Researchers in this study want to learn how the study drug BAY1817080 interacts with another
drug called rosuvastatin (brand name: Crestor) and affects the way the body absorbs,
distributes and excretes rosuvastatin in healthy adult male and female participants
(drug-drug interaction study). The study drug BAY1817080 is a new drug under development with
a goal to suppress pain and chronic cough. It works by binding to and blocking proteins
related to pain in the body. Rosuvastatin is an approved and marketed drug to lower high
levels of "bad" cholesterol (a waxy, fat-like substance found in blood). Both drugs interact
with the same proteins (molecules) in the human body, and as a result, the study drug may
affect the way rosuvastatin is taken up and used by the body when applied together.
Participants in this study will be asked to visit the clinic 3 times over a period of 3 to 4
weeks. Each participant will receive rosuvastatin tablets twice with at least 11 days in
between and the study drug tablets twice daily for 14 days. Blood samples will be taken from
the participants to measure the blood levels of rosuvastatin.
Primary Outcomes
Measure: Maximum plasma concentration of rosuvastatin without concomitant administration of BAY1817080 (Cmax) Time: Predose and up to 15 hours after drug on Day 1, 0 and 12 hours on Day 2, 0 hours on Day 3, 4 and 5 of Period 1
Measure: Maximum plasma concentration of rosuvastatin after concomitant administration of BAY1817080 (Cmax1) Time: Predose and up to 15 hours after rosuvastatin on Day 8, 0 and 12 hours on Day 9, 0 hour on Days 10, 11, 12, 13, 14 and 15 of Period 2
Measure: Area under the concentration-time curve of rosuvastatin without concomitant administration of BAY1817080 (AUC) Time: Predose and up to 15 hours after drug on Day 1, 0 and 12 hours on Day 2, 0 hours on Day 3, 4 and 5 of Period 1
Measure: Area under the concentration-time curve of rosuvastatin after concomitant administration of BAY1817080 (AUC1) Time: Predose and up to 15 hours after rosuvastatin on Day 8, 0 and 12 hours on Day 9, 0 hour on Days 10, 11, 12, 13, 14 and 15 of Period 2
Secondary Outcomes
Measure: Number of participants with treatment-emergent adverse events (TEAEs) Time: Up to 10 weeks
Measure: Severity of treatment-emergent adverse events Time: Up to 10 weeks