A Study to Investigate the Pharmacodynamic Effects of CT327 on Intra-dermal Nerve Growth Factor (NGF) and Evoked Pain Responses, in Healthy Male Volunteers

A Phase I, Single-centre, Multiple-dose, Placebo-controlled Crossover Study to Investigate the Pharmacodynamic Effects of CT327 (0.1% Topical Cream) on Intra-dermal Nerve Growth Factor (NGF) and Evoked Pain Responses, in Healthy Male Volunteers

The primary objective of this study is to compare the effect of CT327 to placebo against experimental induced superficial, deep and hyperalgesic pain.

The secondary objectives are to elucidate the mechanisms of CT327 using experimental pain models.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain
• Intervention / Treatment: Drug: CT327 (or placebo) followed by placebo (or CT327)

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Department of Gastroenterology Aalborg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Subjects must be able to understand the contents of the study, comply with the study and willing to sign informed consent
• Subjects must be free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory and other tests
• All male subjects must take adequate contraceptive precautions during the course of the study and for 30 days after their participation in the study has ended

Exclusion Criteria:

• Participation in other clinical studies within 3 months before screening
• Scheduled for surgery, medical treatment or any hospital admission that would fall within the study
• Use of strong painkillers
• Use of any analgesic within 24 hours before start of study
• Use of a regular course of prescribed medication and/or herbal medicine
• The presence of lesions, significant scars, cuts, wounds, dermal abnormalities, tattoos or naevi in the test areas
• A past history of contact dermatitis, psoriasis or keloid
• Any clinically significant ECG abnormality at screening
• A history of drug or other allergy that contraindicates his participation.
• Regular or average consumption of more than 21 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 125 mL of wine or 20 mL of spirits).
• Smokes more than five cigarettes (on average) per day, or had been a smoker of more than 5 cigarettes (on average) per day within the 3 months prior to screening.
• A known history of drug or alcohol abuse.
• As a result of the medical screening process, the PI or medical delegate considers the subject unfit for the study.
• Use of any prescription medication within 2 weeks or 5 half-lives (whichever is longer) of dosing.
• Use of non-prescription medication (e.g. aspirin, vitamins and herbal and dietary supplements) within 7 days prior to dosing, or 14 days if the medication contained grapefruit/ grapefruit juice or St John's Wort.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT327 treatment period 1; Subjects in Group 1 will receive CT327 during treatment/testing period 1 and placebo during treatment/testing period 2	Drug: CT327 (or placebo) followed by placebo (or CT327); During treatment/testing period 1, subjects will apply 0.25 g CT327 (or placebo) to 4 test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications. During treatment/testing period 2, subjects will apply 0.25 g placebo (or CT327) to 4 different test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications.
Experimental: CT327 treatment period 2; Subjects in Group 2 will receive placebo during treatment/testing period 1 and CT327 during treatment/testing period 2	Drug: CT327 (or placebo) followed by placebo (or CT327); During treatment/testing period 1, subjects will apply 0.25 g CT327 (or placebo) to 4 test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications. During treatment/testing period 2, subjects will apply 0.25 g placebo (or CT327) to 4 different test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
An alteration in the peripheral sensitisation after treatment with CT327	2 treatment/testing periods each lasting 4 days and separated by at least 10 days

Secondary Outcome Measures

Outcome Measure	Time Frame
The change in pain determined with the visual analogue scale (VAS) and the change in areas assessed with von Frey filaments and standardized brush.	2 treatment/testing periods each lasting 4 days and separated by at least 10 days

Collaborators and Investigators

• Sponsor: Creabilis SA
• Collaborators: Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: November 17, 2010
• First Submitted That Met QC Criteria: November 17, 2010
• First Posted (Estimate): November 18, 2010

Study Record Updates

• Last Update Posted (Estimate): June 8, 2011
• Last Update Submitted That Met QC Criteria: June 6, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: CT327-1002