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NCT03212586
BAY 1902607: Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Bioavailability, Food Effect
Phase 1 trial testing BAY1902607 in Clinical Trials, Phase I as Topic in 72 participants. Completed in 27 July 2018.
3 May 2018
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | basic science |
| Enrollment | 72 |
| Start date | 18 July 2017 |
| Primary completion | 3 May 2018 |
| Estimated completion | 27 July 2018 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- BAY1902607 — full drug profile →
- Placebo
Conditions studied
- Clinical Trials, Phase I as Topic — all drugs for Clinical Trials, Phase I as Topic →
Sponsor
Bayer — full company profile →
Who can join
Adults 18 to 45, male only, with Clinical Trials, Phase I as Topic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a first-in-man study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1902607 using a placebo controlled, randomized, single center design. In addition the influence of food on the pharmacokinetics of BAY1902607 and the bioavailability between different pharmaceutical formulations will be investigated
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Safety, Tolerability, and Pharmacokinetics of Filapixant, a Highly Selective P2X3 Receptor Antagonist, in an Ascending-Single-Dose First-in-Human Study.
Francke K, Baumann S, Gashaw I, Klein S, et al · · 2025 · cited 1× · PMID 40430576 · DOI 10.3390/ph18050758
Verify or expand the search:
- PubMed search for NCT03212586
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of BAY1902607
Trials testing the same drug.
- NCT03789890 — Study to Learn More About the Effect of Itraconazole (ITZ) Given Repeatedly by Mouth on the Way How the Study Drug BAY19 · Phase 1 · completed
- NCT03535168 — Repeat Doses of BAY1902607 in Healthy Males and Proof of Concept in Chronic Cough Patients · Phase 1, PHASE2 · completed
Other Bayer trials
Trials by the same sponsor.
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- NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03212586 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 14 May 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03212586.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing