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

This study has been completed.
Sponsor:
Information provided by:
Zalicus
ClinicalTrials.gov Identifier:
NCT00544687
First received: October 15, 2007
Last updated: November 14, 2007
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: CRx-191
Drug: mometasone furoate
Drug: nortriptyline HCl
Drug: Karison® Creme
Drug: Vehicle
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Zalicus:

Primary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: September 2007
Study Completion Date: November 2007
Arms Assigned Interventions
Experimental: 1
CRx-191 (0.1% mometasone furoate + 0.05% nortriptyline HCl)
Drug: CRx-191
topical (mometasone furoate + nortriptyline HCl)
Experimental: 2
CRx-191 (0.1% mometasone furoate + 0.1% nortriptyline HCl)
Drug: CRx-191
topical (mometasone furoate + nortriptyline HCl)
Active Comparator: 3
0.1% mometasone furoate
Drug: mometasone furoate
topical mometasone furoate
Active Comparator: 4
0.1% nortriptyline HCl
Drug: nortriptyline HCl
topical nortriptyline HCl
Active Comparator: 5
Karison® Creme (clobetasol-17-propinate 0.05%)
Drug: Karison® Creme
topical Karison® Creme (clobetasol-17-propinate 0.05%)
Placebo Comparator: 6
Vehicle (placebo)
Drug: Vehicle
topical (placebo)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544687

Locations
Germany
bioskin GmbH
Hamburg, Germany
Sponsors and Collaborators
Zalicus
Investigators
Principal Investigator: Johannes Gassmueller, M.D. Bioskin GmbH
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00544687     History of Changes
Other Study ID Numbers: CRx-191-002, EudraCT Number: 2006-005903-33
Study First Received: October 15, 2007
Last Updated: November 14, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Zalicus:
Skin
Atrophy
CRX-191
mometasone furoate
nortriptyline hydrochloride
Skin Thickness in Normal Healthy Volunteers

Additional relevant MeSH terms:
Nortriptyline
Mometasone furoate
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 26, 2014