Leveraging Healthy Volunteers for Anticancer Drug Clinical Pharmacology Studies: A Review Article Featuring Futibatinib as an Example
Aernout D van Haarst, Sabina Paglialunga, Ziv Machnes, Ikuo Yamamiya, Nanae Hangai, Aram Oganesian · 2026
Read Leveraging Healthy Volunteers for Anticancer Drug Clinical Pharmacology Studies: A Review Article Featuring Futibatinib as an Example by Aernout D van Haarst, Sabina Paglialunga, Ziv Machnes, Ikuo Yamamiya, Nanae Hangai, Aram Oganesian (2026) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/pmc-13539216.txt.
Description
Aernout van Haarst and five co-authors argue a case about healthy volunteers. Such volunteers were long excluded from cancer drug testing. The authors say they can safely carry early pharmacology studies for targeted agents. Cytotoxic chemotherapy made the idea unethical. Kinase inhibitors changed the calculus. They spare patients from non-therapeutic testing. Their running example is futibatinib. It is a receptor-blocking drug approved for a bile duct cancer with specific gene rearrangements.
During the development of futibatinib, studies in healthy volunteers measured key traits. Those traits were absorption and metabolism, drug interaction potential, and cardiac QT risk. The review lays out when enrollment of volunteers is warranted. It states what advantages it buys in speed and clean data. It also states its risks and limits. It serves as guidance for trial planners. They must choose their first-in-human groups with care.
Catalog record
| CREATOR | Aernout D van Haarst, Sabina Paglialunga, Ziv Machnes, Ikuo Yamamiya, Nanae Hangai, Aram Oganesian |
|---|---|
| YEAR | 2026 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 56 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |