TL30: First-Time-In-Human Trials - Everything but the kitchen sink?
*Jennifer LS Gauvin, GlaxoSmithKline  Sharon Cornell Murray, GlaxoSmithKline 


With increasing pressure to do more with less, companies are looking to answer as many questions with their First Time in Human (FTIH) trials as possible. Traditionally, FTIH trials are used to examine the safety of the compound and evaluate PK data in order select an appropriate dose. In oncology trials, they also identify the MTD. However, more and more, FTIH may be multi-part, include cohorts of healthy volunteers and patients, be used to select an appropriate biomarker identifying a subset of the population that may respond well to treatment, give an early evaluation of food effect, confirm the mechanism of action, and even provide a proof of concept. In this roundtable session, we will discuss experiences with complicated FTIH trials and the advantages and disadvantages of the multi-part FTIH strategy.