Hello!Yes, the study will provide pharmacokinetic data on...

Hello!
Yes, the study will provide pharmacokinetic data on paxalisib that any regulatory body will want to see - as you can see it is a Phase I study. Typically this data is available before the drug is tested in patients.
Essentially the study explores what the body “does“ to the drug, how long it takes to eliminate it, how it is metabolised, etc.

Personally, I do not believe it matters which institution analyses the data and provides the results as long as the methods are clearly described and good clinical practices have been adhered to.

Lastly, limiting the study subjects to male subjects is a shortcoming that unfortunately all to common. It won’t reduce the chances of paxalisib‘s success. But it is still based on refuted assumptions that women metabolise and react to drugs the same way as men.