NEO6860 SAD, MAD Study

• Research type

  Research Study

• Full title

  NEO6860: A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male and Female Subjects

• IRAS ID

  166289

• Contact name

  Ashley Brooks

• Contact email

  ashley.brooks@covance.com

• Sponsor organisation

  Neomed

• Eudract number

  2014-004324-22

• Duration of Study in the UK

  0 years, 5 months, 1 days

• Research summary

  NEO6860 is a new drug which acts as a TRPV1 (a kind of pain receptor) blocker and is being developed for the treatment of pain associated with osteoarthritis (OA). OA commonly affects the joints of hands, feet, spine, and large weight bearing joints such as the hips and knees and is mainly due to mechanical stress with insufficient self-repair.
  Currently, the pain associated with OA is mainly treated with NSAIDS (nonsteroidal anti-inflammatory drugs). There are significant risks associated with the use of NSAIDs mainly heart related problems like, heart attack, stroke and blood clot formation, stomach and gut related problems like bleeding, ulceration, and perforation of the stomach or intestines.
  A potent compound acting through a different mechanism, on a new target, would be desirable to avoid the pitfalls of existing medication. Inhibiting the TRPV1 ion channel may be such an approach, which is why this project aims to develop NEO6860 for OA-associated pain.

  The principal aim of this study is to obtain safety and tolerability data when NEO6860 is administered orally as single and multiple doses to healthy subjects. The experimental pain perception assessment (Capsaicin model) will enable a dose (concentration) response curve to provide early information of the pain relieving effects of NEO6860; the impact of NEO6860 on heat pain threshold and body temperature will also be evaluated. The study incorporates a group in the single ascending dosing, to investigate the effects of food on the pharmacokinetics of NEO6860 prior to patient studies. The study also comprises a single group of all female subjects, to investigate any gender effect. All of this information, together with the pharmacokinetic data (concentration of drug in the blood), will help establish the doses and dosage regimen suitable for administration to patients.

• REC name

  North East - York Research Ethics Committee

• REC reference

  14/NE/1178

• Date of REC Opinion

  3 Dec 2014

• REC opinion

  Further Information Favourable Opinion