PAREXEL International Corporation, a biopharmaceutical services provider, has completed a large and complex pharmacogenetics-based early phase study. The study was conducted in a healthy volunteer population of poor metabolizers of Cytochrome P450 2D6 (CYP2D6), an important enzyme involved in the metabolism of drugs. The study monitored the QTc interval following administration of a neurological treatment, which has been shown to have a higher drug exposure in poor metabolizers of CYP2D6.
More than 10,000 potential study participants were genotyped by PAREXEL to identify nearly 400 CYP2D6 poor metabolizers. Of these individuals, nearly 300 were screened for eligibility to achieve the goal of enrolling more than 130 CYP2D6 poor metabolizers for this study. PAREXEL's rapid recruitment strategies for early phase development enabled management of the large pool for genotyping and contributed to accelerating development timelines and quickly achieving milestone targets.
"All of our early phase units have experience performing studies in genotyped populations. As personalized medicine continues to evolve, biopharmaceutical companies are working with our experts to target specific, well-defined study populations," said Michelle Middle, MB ChB, Corporate Vice President and Worldwide Head of Early Phase, PAREXEL International. "This study is an example of how we help our clients significantly decrease their timelines by utilizing the strategic capabilities of our early phase unit locations worldwide to accelerate volunteer recruitment." Key goals of the study, conducted at PAREXEL's early phase units in South Africa, were to evaluate a possible drug effect on cardiac repolarization, as defined by QT/QTc prolongation, and to assess safety and tolerability. The low prevalence of CYP2D6 poor metabolizers, complex inclusion criteria and the long duration of the thorough QT/QTc study, with four periods each lasting 15 days, were identified as major recruitment challenges; however, PAREXEL's early phase experts were able to complete the study in only nine months.
PAREXEL's early phase services provide fully integrated solutions from First in Man through Proof of Concept and help biopharmaceutical companies generate better and faster go/no-go decisions about their compounds, while striving to return solid, reproducible outcomes, which bode well for success in later-phase trials. PAREXEL's early phase capabilities include a full scope of early phase studies, specialized trial design, state-of-the-art technologies, hospital-based resources, and scientific expertise as well as vast experience in the oncology, neurology, cardiology, respiratory, and metabolism/endocrine therapeutic areas.