drugset / Trial / NCT03310645
Repeat Doses of BAY 1817080 in Healthy Males & Proof of Concept in Chronic Cough Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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).
Timeline
- Start
- 2017-12-07
- Primary completion
- 2019-05-28
- Completion
- 2019-06-19
Publications
- Reif S, Schultze-Mosgau MH, Engelen A, Piel I, Denner K, Roffel A, Tiessen R, Klein S, Francke K, Rottmann A. Mass Balance and Metabolic Pathways of Eliapixant, a P2X3 Receptor Antagonist, in Healthy Male Volunteers. Eur J Drug Metab Pharmacokinet. 2024 Jan;49(1):71-85. doi: 10.1007/s13318-023-00866-0. Epub 2023 Dec 3.
- Friedrich C, Francke K, Gashaw I, Scheerans C, Klein S, Fels L, Smith JA, Hummel T, Morice A. Safety, Pharmacodynamics, and Pharmacokinetics of P2X3 Receptor Antagonist Eliapixant (BAY 1817080) in Healthy Subjects: Double-Blind Randomized Study. Clin Pharmacokinet. 2022 Aug;61(8):1143-1156. doi: 10.1007/s40262-022-01126-1. Epub 2022 May 28.
- Morice A, Smith JA, McGarvey L, Birring SS, Parker SM, Turner A, Hummel T, Gashaw I, Fels L, Klein S, Francke K, Friedrich C. Eliapixant (BAY 1817080), a P2X3 receptor antagonist, in refractory chronic cough: a randomised, placebo-controlled, crossover phase 2a study. Eur Respir J. 2021 Nov 18;58(5):2004240. doi: 10.1183/13993003.04240-2020. Print 2021 Nov.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | eliapixant | Small molecule | 10 mg | Oral |
| Subject | eliapixant | Small molecule | 50 mg | Oral |
| Subject | eliapixant | Small molecule | 200 mg | Oral |
| Subject | eliapixant | Small molecule | 750 mg | Oral |
Indications
No indication recorded.