Phase I Study of Topical CRx-191 in Normal Healthy Volunteers

November 14, 2007 updated by: Zalicus

A Phase I, Single-Center, Randomized, Vehicle and Active-Controlled Study to Assess and Compare the Atrophy-Causing Potential of Topical CRx-191 Formulations in Healthy Volunteers

CRx-191 is a proprietary synergistic combination drug candidate being evaluated by CombinatoRx for topical psoriasis therapy. CRx-191 was identified via a proprietary screening assay for novel drug combinations demonstrating enhanced inhibition of tumor necrosis factor- alpha and interferon-gamma release, cytokines that are implicated in the pathogenesis of psoriasis.

Study Overview

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hamburg, Germany
        • Bioskin GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject must voluntarily give written informed consent
  • Subject must be at least 18 years of age
  • Subject must have healthy skin on which reddening can be easily recognized in the area of the test fields
  • The physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study
  • Sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen; systemic contraceptive (combined oral contraceptive, implant, injection), or safe intrauterine device (IUD)
  • Written informed consent obtained

Exclusion Criteria:

  • Acne, suntan, eczema, hyper- or hypopigmentation, or tattoos in the test fields
  • Dark skinned persons whose skin color prevents ready assessment of skin reactions
  • Cardiac disease including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and valvular heart disease
  • Mania
  • Narrow angle glaucoma
  • Hyperthyroidism by medical history, TSH < LLN, or receiving thyroid medication
  • Severe liver disease (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) laboratory values that exceed 1.5x ULN)
  • Inflammatory dermatoses (e.g. atopic dermatitis, psoriasis), bacterial, viral, or fungal skin infections; facial rosacea
  • Active varicella, tuberculosis, syphilis or post-vaccine reactions
  • Autoimmune disease (e.g., lupus erythematosis)
  • Known allergic reactions or hypersensitivity to any of the components of the study preparations
  • Allergy to adhesives on the patches used for occlusion in this study
  • UV therapy in the four weeks before the study
  • History of malignancy (except for treated or excised basal cell carcinoma)
  • Surgery within the previous 3 months (except for minor cosmetic or dental procedures)
  • History of drug or alcohol abuse (as defined by the Investigator)
  • Symptoms of a clinically significant illness in the four weeks before the study that may influence the outcome of the study
  • Positive for human immunodeficiency virus (HIV) antibody
  • Systemic treatments in the two weeks preceding and during the study that may interact with any of the study drugs, such as: Glucocorticoids (po, im, iv), MAO inhibitors, Anti-depressants, Anti-seizure medications, Anti-psychotics, Antihistamines
  • Subjects who require medications that inhibit the cytochrome P450 (CYP450) 2D6 pathway such as: Quinidine, Cimetidine, Type 1 antiarrhythmics, Phenothiazines, Selective serotonin reuptake inhibitors such as fluoxetine, paroxetine, and sertraline, reserpine, other anticholinergic drugs, and sympathomimetic drugs
  • Participation in another clinical trial and/or treatment received with any investigational agent within one month before the initial dose of study medication
  • Female subject who is pregnant or lactating
  • Significant UV exposure in the four weeks before the study
  • Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule
  • Other unspecified reasons that, in the opinion of the Investigator or sponsor make the subject unsuitable for enrollment
  • Subject is institutionalized because of legal or regulatory order

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
CRx-191 (0.1% mometasone furoate + 0.05% nortriptyline HCl)
topical (mometasone furoate + nortriptyline HCl)
Experimental: 2
CRx-191 (0.1% mometasone furoate + 0.1% nortriptyline HCl)
topical (mometasone furoate + nortriptyline HCl)
Active Comparator: 3
0.1% mometasone furoate
topical mometasone furoate
Placebo Comparator: 6
Vehicle (placebo)
topical (placebo)
Active Comparator: 4
0.1% nortriptyline HCl
topical nortriptyline HCl
Active Comparator: 5
Karison® Creme (clobetasol-17-propinate 0.05%)
topical Karison® Creme (clobetasol-17-propinate 0.05%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Full skin thinning produced by treatment of CRx-191 in comparison with its components at corresponding dose levels, and vehicle with a marketed corticosteriod. Assess tolerability and safety of CRx-191.
Time Frame: 28 Days
28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Johannes Gassmueller, M.D., Bioskin GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

October 15, 2007

First Submitted That Met QC Criteria

October 15, 2007

First Posted (Estimate)

October 16, 2007

Study Record Updates

Last Update Posted (Estimate)

November 15, 2007

Last Update Submitted That Met QC Criteria

November 14, 2007

Last Verified

November 1, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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