Study to Learn the Effect of Drug BAY1817080 on the Way the Body Absorbs, Distributes and Excretes Another Drug Rosuvastatin in Healthy Adult Participants

Study Overview
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Brief Summary
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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.

Detailed Description
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The primary objective of the study is to investigate the influence of multiple doses of BAY1817080 on the pharmacokinetics of rosuvastatin given concomitantly. Secondary objective is to investigate the safety of BAY1817080.

Official Title
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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

Conditions
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Drug Interactions

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Rosuvastatin + BAY1817080


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is healthy as determined by the investigator White or Black race Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m² at screening Body weight of at least 50 kg at screening Exclusion Criteria: Known or suspected allergy or hypersensitivity to BAY1817080, rosuvastatin or any of their excipients Asian race Contraindications to rosuvastatin Any use of systemic or topically active medication or herbal remedies, prescription or non-prescription, within 1 week prior to the first study intervention administration or during the study until follow-up (occasional use of ibuprofen is permissible) History of or positive COVID-19 test or contact with COVID-19 positive subject in past 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy subjects_Period 1<br>Healthy adults from USA receive a single dose of rosuvastatin (interaction drug) in Period 1. | Drug: Rosuvastatin<br>* Single dose of 5 mg rosuvastatin is administered as tablet orally on Day 1 of Period 1 (total length = 5 days).<br>* Other names: Crestor®;|
| Experimental: Healthy subjects_Period 2<br>The healthy adults from Period 1 receive both rosuvastatin + BAY1817080 in Period 2. | Drug: Rosuvastatin + BAY1817080<br>* 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.<br>* Other names: Crestor®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration of rosuvastatin without concomitant administration of BAY1817080 (Cmax) |  | 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) |  | 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) |  | 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) |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-emergent adverse events (TEAEs) |  | Up to 10 weeks | 
| Severity of treatment-emergent adverse events |  | Up to 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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P2X3 receptor antagonist, Rosuvastatin, Organic Anion Transporting Polypeptide 1B1 (OATP1B1), Organic Anion Transporting Polypeptide 1B3 (OATP1B3), Breast Cancer Resistance Protein (BCRP), Pain, Chronic cough, Cholesterol