I received a query by email seeking my opinion concerning the topic mentioned above. The email is attached (link), without reference of the sender, to provide a background of my response. My opinion is as follows:
First, what is a phase I clinical study? In general, a phase I clinical study is a study in which a drug is to be evaluated in humans for the first time, following successful animals studies, to establish its safety and tolerability in different dosage strengths. In principle, at this stage, there would not be any data available on human pharmacokinetics (absorption, metabolism, elimination, volume of distribution, etc.), and this phase of the study is generally used for determining these parameters. If the drug is to be administered as a solid oral product such as a tablet/capsule or suspension, then such a product is to be “developed”. [link for full response]