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NCT03484585
Rogaratinib (BAY1163877) Human Mass Balance Study
Phase 1 trial testing Rogaratinib (BAY1163877) in Clinical Trial, Phase I in 6 participants. Completed in 9 August 2018.
25 May 2018
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 6 April 2018 |
| Primary completion | 25 May 2018 |
| Estimated completion | 9 August 2018 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Rogaratinib (BAY1163877) — full drug profile →
Conditions studied
- Clinical Trial, Phase I — all drugs for Clinical Trial, Phase I →
- Pharmacokinetics — all drugs for Pharmacokinetics →
Sponsor
Bayer — full company profile →
Who can join
Adults 21 to 65, male only, with Clinical Trial, Phase I or Pharmacokinetics. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study is to determine the mass balance and routes of excretion of total radioactivity after a single oral 200 mg dose of \[14C\]rogaratinib given as a solution. For further clinical development, human mass balance data are required to elucidate the absorption, distribution, metabolism, and excretion (ADME) of rogaratinib.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03484585
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Rogaratinib (BAY1163877)
Trials testing the same drug.
- NCT04125693 — Roll-over Study to Continue Treatment With the Investigational Drug Rogaratinib and to Further Test Its Safety · Phase 2 · completed
- NCT03788603 — Rogaratinib (BAY1163877) in Chinese Patients · Phase 1 · completed
- NCT03517956 — Phase 1 Study of the Combination of Rogaratinib With Copanlisib in Patients With Fibroblast Growth Factor Receptor (FGFR · Phase 1 · completed
- NCT03410693 — Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Loc · Phase 2, PHASE3 · completed
- NCT03473756 — Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma · Phase 1 · 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 NCT03484585 (US National Library of Medicine, public domain)
- 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 August 2018
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/NCT03484585.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing