NEO6860, a TRPV1 Antagonist, First in Human Study

Osteoarthritis, Knee Clinical Trial

Official 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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. Measurement of capsaicin evoked pain, and secondary hyperalgesia will be performed at baseline and at estimated Tmax and 8 hours post dosing.

Part A will comprise an ascending single dose, sequential group study in male subjects, incorporating a two-period crossover group to investigate the effect of food and a single group of female subjects to investigate gender effect.

56 subjects will be studied in 7 groups (Groups A1 to A7), each group consisting of 8 subjects (6 subjects will receive NEO6860 and 2 will receive placebo). Six dose levels will be explored: 50, 100, 200, 400, 800 and 1 600mg.

Part B will comprise an ascending multiple dose, sequential group study. 16 subjects will be studied in 2 groups (Groups B1 to B2), each group consisting of 8 subjects (6 subjects will receive NEO6860 and 2 will receive placebo) receiving 5 days of therapy with a dose schedule to be determined during Part A. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis, Knee

• NCT number: NCT02337543
• Study type: Interventional
• Source: Neomed Institute
• Status: Completed
• Phase: Phase 1
• Start date: January 2015
• Completion date: July 2015