CLINICAL TRIALS PROFILE FOR BAY1817080
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Clinical Trials for BAY1817080
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT02817100 ↗ | First in Human Study to Investigate the Safety and Tolerability, Pharmacokinetics, Itraconazole Drug-drug-interaction and Food Effect of BAY1817080 | Completed | Bayer | Phase 1 | This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1817080 using a placebo controlled, randomized, single center design. In addition the influence of itraconazole and food on the pharmacokinetics of BAY1817080 will be investigated. |
| NCT03310645 ↗ | Repeat Doses of BAY 1817080 in Healthy Males & Proof of Concept in Chronic Cough Patients | Completed | Bayer | Phase 1/Phase 2 | To investigate the safety and tolerability of ascending repeated oral doses of BAY1817080 in healthy volunteers(Part1). To investigate the safety, tolerability and efficacy of BAY1817080 in patients with refractory chronic cough(Part2). |
| NCT03773068 ↗ | A Study in Healthy Volunteers Investigating How Quickly and to What Extent BAY1817080 is Taken up, Distributed, Broken Down and Eliminated From the Body, as Well as the Difference Between 2 Different Types of Tablets of BAY1817080 and the Difference | Completed | Bayer | Phase 1 | The main purpose of this study is to investigate how quickly and to what extent BAY1817080 is absorbed (taken up), distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). The pharmacokinetics of BAY1817080 administered as tablets will be compared to the pharmacokinetics of BAY1817080 administered as intravenous (iv; in the vein) infusion (this is called absolute bioavailability). Furthermore, 2 different types of tablets with BAY1817080 (Formulation A and Formulation B) will be compared with regard to pharmacokinetics (this is called relative bioavailability). The effect of a meal on the pharmacokinetics of BAY1817080 administered as tablets will be investigated as well. Finally, it will also be investigated how safe BAY1817080 is and how well BAY1817080 is tolerated. |
| NCT04252300 ↗ | Study to Learn the Effect of Drug BAY1817080 on the Way the Body Absorbs, Distributes and Excretes Another Drug Rosuvastatin in Healthy Adult Participants | Completed | Bayer | Phase 1 | 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. |
| NCT04265781 ↗ | Study on the Safety of Drug BAY1817080 at Different Doses and the Way the Body Absorbs and Eliminates the Drug in Japanese Healthy Adult Male Participants | Completed | Bayer | Phase 1 | Researchers in this study want to learn about the safety of drug BAY1817080 at different doses and the resulting blood levels of the study drug in Japanese healthy adult male participants. Study drug BAY1817080 is a drug under development with a goal to suppress pain and chronic cough. It works by binding to and blocking proteins expressed on the sensory nerves of the womb tissue, bladder or airway which are oversensitive in the patients with endometriosis (a condition where the tissue that usually grows inside the womb grows outside of the womb), overactive bladder (a condition that causes a sudden urge to urinate often or more frequently) and long-standing cough with or without clear causes. Participants in this study will receive either the study drug or placebo tablets (a placebo looks like the test drug but does not have any medicine in it). The dosage will be either one single dose of study drug/placebo received on only one day or multiple doses of study drug/placebo received twice daily for 13 days plus one dose in the morning of the 14th day. The total study duration for each participant will be usually no more than 42 days. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug. |
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