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

NCT ID: NCT00544687

Last Updated: 2007-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2007-11-30

Brief Summary

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.

Conditions

Healthy

Keywords

Skin; Atrophy; CRX-191; mometasone furoate; nortriptyline hydrochloride; Skin Thickness in Normal Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

CRx-191 (0.1% mometasone furoate + 0.05% nortriptyline HCl)

Group Type: EXPERIMENTAL

CRx-191

Intervention Type: DRUG

topical (mometasone furoate + nortriptyline HCl)

2

CRx-191 (0.1% mometasone furoate + 0.1% nortriptyline HCl)

Group Type: EXPERIMENTAL

CRx-191

Intervention Type: DRUG

topical (mometasone furoate + nortriptyline HCl)

3

0.1% mometasone furoate

Group Type: ACTIVE_COMPARATOR

mometasone furoate

Intervention Type: DRUG

topical mometasone furoate

4

0.1% nortriptyline HCl

Group Type: ACTIVE_COMPARATOR

nortriptyline HCl

Intervention Type: DRUG

topical nortriptyline HCl

5

Karison® Creme (clobetasol-17-propinate 0.05%)

Group Type: ACTIVE_COMPARATOR

Karison® Creme

Intervention Type: DRUG

topical Karison® Creme (clobetasol-17-propinate 0.05%)

6

Vehicle (placebo)

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

topical (placebo)

Interventions

CRx-191

topical (mometasone furoate + nortriptyline HCl)

Intervention Type: DRUG

mometasone furoate

topical mometasone furoate

Intervention Type: DRUG

nortriptyline HCl

topical nortriptyline HCl

Intervention Type: DRUG

Karison® Creme

topical Karison® Creme (clobetasol-17-propinate 0.05%)

Intervention Type: DRUG

Vehicle

topical (placebo)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zalicus

INDUSTRY

Sponsor Role: lead

Principal Investigators

Johannes Gassmueller, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bioskin GmbH

Locations

bioskin GmbH

Hamburg, , Germany

Countries

Germany

Other Identifiers

EudraCT Number: 2006-005903-33

Identifier Type: -

Identifier Source: secondary_id

CRx-191-002

Identifier Type: -

Identifier Source: org_study_id