Study to Learn the Effect of Drug BAY1817080 on the Way the Body Absorbs, Distributes and Excretes Another Drug Rosuvastatin in Healthy Adult Participants
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|ClinicalTrials.gov Identifier: NCT04252300|
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : June 17, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Drug Interactions||Drug: Rosuvastatin Drug: Rosuvastatin + BAY1817080||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Open Label, Fixed Sequences, One-way Cross-over Study to Determine the Effects of Multiple Doses BAY1817080 (150 mg) on the Pharmacokinetics of a 5 mg Dose Rosuvastatin in Healthy Participants|
|Actual Study Start Date :||March 2, 2020|
|Estimated Primary Completion Date :||July 19, 2020|
|Estimated Study Completion Date :||September 19, 2020|
Experimental: Healthy subjects_Period 1
Healthy adults from USA receive a single dose of rosuvastatin (interaction drug) in Period 1.
Single dose of 5 mg rosuvastatin is administered as tablet orally on Day 1 of Period 1 (total length = 5 days).
Other Name: Crestor®
Experimental: Healthy subjects_Period 2
The healthy adults from Period 1 receive both rosuvastatin + BAY1817080 in Period 2.
Drug: Rosuvastatin + BAY1817080
A single dose of 5 mg rosuvastatin tablets is administered on Day 8 of Period 2 (total length = 15 days). BAY1817080 is administered as tablets twice daily on Days 1 to 14 of Period 2.
- Maximum plasma concentration of rosuvastatin without concomitant administration of BAY1817080 (Cmax) [ Time Frame: 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 ]
- Maximum plasma concentration of rosuvastatin after concomitant administration of BAY1817080 (Cmax1) [ Time Frame: 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 ]
- Area under the concentration-time curve of rosuvastatin without concomitant administration of BAY1817080 (AUC) [ Time Frame: 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 ]
- Area under the concentration-time curve of rosuvastatin after concomitant administration of BAY1817080 (AUC1) [ Time Frame: 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 ]
- Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 10 weeks ]
- Severity of treatment-emergent adverse events [ Time Frame: Up to 10 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252300
|Contact: Bayer Clinical Trials Contact||(+)1-888-84 email@example.com|
|United States, Florida|
|Covance Clinical Research Unit, Inc.||Recruiting|
|Daytona Beach, Florida, United States, 32117|