Follow on Google News News By Tag Industry News News By Location Country(s) Industry News
Follow on Google News | Quotient Clinical completes innovative first-in-human programResults from the Enabled-First-in-Human® program on an oncology molecule in healthy volunteers published at AACR
By: Quotient Clinical 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 EnabledFIH 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). End
Account Email Address Disclaimer Report Abuse
|
|