Adverse Reactions in a Phase 1 Trial of the Anti-Malarial DM1157: An Example of Pharmacokinetic Modeling and Simulation Guiding Clinical Trial Decisions.

Stephen J BalevicShruti M RajaRachel RandellGregory A DeyeThomas ConradAya NakamuraDavid H PeytonSandra ShotwellKatherine LiebmanMichael Cohen-WolkowiezJeffrey T Guptill

Published in: Infectious diseases and therapy (2022)

This study provides an important example of the risks and challenges of conducting early phase research as well as the role of modeling and simulation to optimize participant safety (ClinicalTrials.gov, NCT03490162).

Keyphrases

clinical trial
virtual reality
open label
randomized controlled trial
study protocol
type diabetes
insulin resistance
phase iii