A randomized phase I study of the safety and pharmacokinetics of BI 1291583 in healthy Japanese male subjects
The results show that BI 1291583 has an appropriate benefit-risk ratio for Japanese patients, with no safety or exposure concerns at the doses studied. Japanese patients with bronchiectasis can be safely integrated into future global clinical trials of BI 1291583, with no dose adjustment required.
Authors
- Takumi Furuichi
- Donald Sarubbi
- Yusuke Tadayasu (ORCID: https://orcid.org/0000-0003-2974-9317)
- Wiebke Sauter
- Shuhei Nakamura (ORCID: https://orcid.org/0000-0002-9195-2132)
- Anastasia G Eleftheraki (ORCID: https://orcid.org/0000-0003-1826-4699)
- Ryuzo Hanada
Institutions
- Boehringer Ingelheim (Germany) (DE)
- SOUSEIKAI Global Clinical Research Center (JP)
- Boehringer Ingelheim (Japan) (JP)
- Boehringer Ingelheim (United States) (US)
Publication Details
- Journal
- British Journal of Clinical Pharmacology
- Published
- 2024-09-19
- DOI
- https://doi.org/10.1111/bcp.16249
- Citations
- 2
- Primary Topic
- Cystic Fibrosis Research Advances
- Type
- article
- Field-Weighted Citation Impact
- 0.84
Funders
- Boehringer Ingelheim