NEO6860, a TRPV1 Antagonist, First in Human Study

Summary

This study is a double blind, placebo controlled, ascending single and multiple oral dose study conducted in two parts, aimed at determining the safety and tolerability of single and multiple oral doses of NEO6860 in healthy subjects. Key secondary objectives are: assessment of the pharmacokinetic profile, effect of food and gender. The analgesic effect of NEO6860 will be investigated using experimental capsaicin-evoked pain methods. Part A will comprise an ascending single dose, with 6 dose levels. Part B will comprise an ascending multiple dose, with 2 dose levels.

Timeline

Start

2015-01

Primary completion

2015-07

Completion

2015-07

Publications

• Brown W, Leff RL, Griffin A, Hossack S, Aubray R, Walker P, Chiche DA. Safety, Pharmacokinetics, and Pharmacodynamics Study in Healthy Subjects of Oral NEO6860, a Modality Selective Transient Receptor Potential Vanilloid Subtype 1 Antagonist. J Pain. 2017 Jun;18(6):726-738. doi: 10.1016/j.jpain.2017.01.009. Epub 2017 Feb 8.

Drugs

Indications