Quotient Clinical has announced the publication of results from an Enabled-First-in-Human (Enabled-FIH) program conducted for the Janssen WAVE Early Development unit. The integrated pharmaceutical development and first-in-human clinical program was designed to develop an optimal oral formulation, in parallel with the assessment of single and multiple dose safety, pharmacokinetics and pharmacodynamics of a highly selective small molecule c-Met tyrosine kinase inhibitor.
The clinical phase, which was conducted under a single, adaptive protocol, was completed in only six months. The single ascending dose phase began with a simple solution, and the protocol included the option to assess the relative bioavailability of up to two solid oral dosage formulations.
The transition from solution to a solid dosage form was successfully achieved and this product was used to complete the remaining single and multiple doses. The clinical protocol also included flexible options to assess food effect, dosing frequency and administration to older subjects. Dose proportional increases in exposure were observed and all doses were safe and well tolerated.
Mark Egerton, CEO of Quotient Clinical, commented: “We were very pleased to undertake this program. This is an excellent example of how our innovative Enabled-FIH service can support and accelerate an early development program. Timelines are shortened and the consumption of drug substance is reduced by >85 % compared to a conventional program, delivering significant cost savings. We believe that Enabled-FIH represents an important step forward in helping the industry to improve overall R&D productivity.”
The results will be published on poster CT309 at the American Association of Cancer Research (AACR) 2015 Annual Meeting, Philadelphia, USA. 18-22 April 2015 (Millington DA, Chaplan SR, Aguilar Z et al. Rapid evaluation of a novel small molecule c-Met tyrosine kinase inhibitor in healthy subjects).