Parexel Completes Early Phase Pharmacogenetics Study

Parexel International Corporation has completed a pharmacogenetics-based early phase study. The study was conducted in a healthy volunteer population of poor metabolizers of Cytochrome P450 2D6 (CYP2D6), an 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 the enzyme.

More than 10,000 potential study participants were genotyped to identify nearly 400 CYP2D6 poor metabolizers. Of these individuals, nearly 300 were screened for the eligibility to achieve the goal of enrolling more than 130 CYP2D6 poor metabolizers for this study. The company’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.

Key goals of the study, conducted 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; The company’s early phase experts were able to complete the study in nine months.