NEO6860, a TRPV1 Antagonist, First in Human Study

NCT02337543 | Completed Phase 1 DMC

• 1 other identifier: NEO6860-1301
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of NEO6860 in healthy subjects

  10 days

Secondary Outcomes (4)

• Pharmacokinetics of NEO6860 in healthy subjects

  10 days

• Food effect on Pharmacokinetics of NEO6860 in healthy subjects

  10 days

• Gender effect on Pharmacokinetics of NEO6860 in healthy subjects

  10 days

• Pharmacodynamics effect (ID Capsaicin test) of NEO6860 in healthy subjects

  10 days

Study Arms (2)

Active: NEO6860

EXPERIMENTAL

NEO6860 suspension is the drug under evaluation

Drug: NEO6860

placebo

PLACEBO COMPARATOR

Placebo matching NEO6860 suspension formulation

Drug: Placebo

Interventions

NEO6860 DRUG

NEO6860 is an NCE acting as a TRPV1 antagonist

Active: NEO6860

Placebo DRUG

Placebo

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females Any ethnic origin Between 18 and 55 years of age Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive Body weight between 50 kg and 100 kg inclusive Subjects must be in good health, as determined by Medical history, Physical examination, Vital sign assessment, 12-lead electrocardiogram (ECG), Clinical laboratory evaluations (congenital non-haemolytic hyperbilirubinaemia is acceptable) Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions

You may not qualify if:

• Male subjects who are not willing, or whose partners are not willing, to use appropriate contraception (such as a condom with spermicidal foam/gel/film/cream/suppository), or to refrain from donating sperm from the time of the first dose until 3 months after the final dosing occasion.
• Subjects who have donated blood in the 3 months prior to screening, plasma in the 7 days prior to screening or platelets in the 6 weeks prior to screening Subjects who consume more than 28 units of alcohol per week if male or consume more than 21 units of alcohol per week if female
• Subjects who have used any medication within 7 days of the first dose administration, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety:
• Subjects who have a clinically significant pulse rate, blood pressure or temperature that, in the opinion of the investigator, increases the risk of participating in the study, in accordance with the CRU reference ranges at screening and prior to first dose Subjects with a positive urine drug screen (confirmed by repeat) at screening or first admission, or a positive alcohol breath test result (confirmed by repeat) at screening or first admission Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, in accordance with the CRU reference ranges at screening Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorders as determined by the Investigator ALT or AST \>1.5 times ULN at screening and/or prior to first dose, confirmed by repeat testing Subjects considered non-acceptable responders to the intradermal capsaicin test at screening, defined as maximum VAS score of \<3 or 10 Subjects who, in the opinion of the Investigator, should not participate in the study

Sponsors & Collaborators

• Neomed Institute: lead
• Covance: collaborator

Study Sites (1)

Covance Cru

Leeds, LS2 9LH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 28188907 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Dan A Chiche, MD

  Neomed Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 13, 2015
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 10, 2016

Record last verified: 2015-10

Locations

GB (1)