First-in-Human (FIH) trials in the early phases of drug development represent a critical milestone in the approval of medicines. Their purpose is to study the human pharmacology, pharmacokinetics (PK) and pharmacodynamics (PD), tolerability, and safety of an investigational medicinal product (IMP) having already gone through preclinical studies, and to evaluate how the effects translate from animals to humans. 

They may also include the collection of data on food or drug interactions, different age groups or gender, proof of concept, and relative bioavailability of different formulations.

In Issue 10 of The Altascientist, we review:

• Designing a FIH trial
• Key aspects of FIH trial designs
• Access to patient populations
• Integrating adaptive designs into FIH trials
• A single-center, randomized, placebo-controlled, double-blind, adaptive, FIH study case study

Electrocardiography (ECG) is an integral part of the new drug regulatory environment. Mandated by regulatory bodies the world over, the thorough and precise evaluation of a new drug’s cardiac effects is a critical element of new chemical entity (NCE) development. Sponsors must submit all NCEs with systemic exposure to a dedicated thorough QT (TQT) study to understand the drug’s impact on ECG parameters and determine whether the compound prolongs the QTc interval.

A positive finding of QT prolongation usually has a significant negative impact on a drug's development pathway, necessitating extensive additional ECG assessments, and potentially resulting in approval delays or even discontinuation of the program.

In Issue 9 of The Altascientist, we review:

• Electrocardiography
• Global regulations
• QT/QTc study design
• Timing of QT assessments
• A case study about a first-in-human clinical trial involving a QT assessment