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NEO6860, a TRPV1 Antagonist, First in Human Study

NCT02337543 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2016-03-10

No results posted yet for this 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.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

NEO6860

NEO6860 is an NCE acting as a TRPV1 antagonist

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Neomed Institute

    lead OTHER

Principal Investigators

  • Dan A Chiche, MD · Neomed Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02337543 on ClinicalTrials.gov