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FDA Approval of Oral Testosterone Replacement Enabled by Phoenix NLME & Trial Simulator

Tue, May 12th 2020

Testosterone is a hormone that plays a key role in masculine growth and development during puberty. Hypogonadism is a clinical syndrome that results from failure of the testes to produce physiological levels of testosterone (T) (androgen deficiency) and a normal number of spermatozoa because of disruption of one or more levels of hypothalamic pituitary-testicular axis. Hypogonadism may result from a genetic abnormality or may occur secondary to a chronic disease or from certain drug therapies. Clarus Therapeutics developed and received FDA approval for an oral testosterone (T) replacement product for treating men with certain forms of hypogonadism.

This webinar reviews the application of Certara modeling and simulation tools that contributed to the success of this approval.

The goal of T replacement therapy is to maintain T concentrations in a defined “normal” range. One of the objectives of the phase 3 program was to establish dose titration guidelines using a single measured T concentration as the basis for dose adjustment as mandated by the FDA.

Thus, when Clarus was developing this product, they had to answer several key questions:

  1. What was the optimal collection time window for the blood sample that would be used to guide dose adjustment?
  2. What were the upper and lower T concentration thresholds that would trigger a dose adjustment?
  3. What starting dose and dose titration strategy should be used on initiation of therapy?

To answer these questions and confirm the impact on meeting FDA criteria for PK efficacy and PK safety, population PK modeling and simulation analysis was needed. Phoenix NLME, Certara’s population PK/PD modeling tool, was used to develop a population PK model for oral T. Simulation using the adaptive trial design was performed using Trial Simulator, Certara’s trial simulation tool.

About our Speaker

Dr. Nastya Kassir joined Certara (formerly Pharsight Corporation) in August 2008. She has applied PK and PK/PD modeling and simulation tools to drug development decisions across a range of therapeutic areas. Her expertise includes scientific and regulatory consultation on drug development programs for small and large molecules in various phases of drug development, particularly in pediatrics, orphan diseases and in the therapeutic areas of inflammation (rheumatoid arthritis, psoriasis, psoriatic arthritis) and oncology. Nastya has authored or co-authored more than 60 abstracts/manuscripts in the field of PK/PD. Dr. Kassir has a PharmD and has earned a PhD in Pharmaceutical Sciences from the University of Montreal, Faculty of Pharmacy and is a fellow of the American College of Clinical Pharmacology.

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