ISSUE NO. 25 — Flexibility in Phase I Study Timing

The structure of an early-phase drug development pathway is not set in stone. In fact, certain studies that are generally considered Phase I do not have to be conducted before Phase II commences. Conversely, some studies that are typically done in Phase II can be advanced into a Phase I combined protocol to have access to key data earlier in the program. Early Phase I studies have become increasingly complex in order to gather comprehensive data related to safety and drug pharmacology. Having early access to trial results and data helps inform decisions later in the development journey, can support funding opportunities, and helps solidify the overall plan around sound data.

In Issue 25 of The Altascientist: 
•    Timing of early clinical pharmacology studies
•    Phase I combined protocols 
•    Special populations 
•    Resource allocation 
•    Examples of flexible Phase I study timing

Designing Early Clinical Pharmacology Studies

Phase I clinical pharmacology studies of an investigational drug are designed mainly to investigate safety and tolerability at a range of doses (where possible, develop target therapeutic dose range) and characterize the pharmacokinetics (PK) and pharmacodynamics (PD).

Therapeutic exploratory studies are required milestones, while clinical pharmacology studies include both mandatory and conditional studies. Conditional studies need only be conducted where specific safety data must be acquired for regulatory approval. These studies can sometimes be scheduled at different stages of the program, depending on the specifics of the investigational product. In some cases, such studies can be waived with supporting data.

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