Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Phase I Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Zalicus
ClinicalTrials.gov Identifier:
NCT00721331
First received: July 21, 2008
Last updated: September 24, 2008
Last verified: September 2008
  Purpose

This will be a phase I, single center, randomized, vehicle-controlled, blinded study comparing two dosage strengths of CRx-197 cream, nortriptyline, an active comparator (0.1% mometasone) and placebo (the active ingredient free vehicle cream of CRx-197)in healthy volunteers.


Condition Intervention Phase
Atopic Dermatitis
Drug: nortriptyline HCl + loratadine
Drug: nortriptyline HCl
Drug: mometasone furoate
Drug: Active ingredient free vehicle cream of CRx-197
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I, Single-Center, Randomized, Vehicle-Controlled Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Zalicus:

Primary Outcome Measures:
  • Safety and tolerability of CRx-197 as assessed by treatment emergent adverse events, physical exams, vital signs, concomitant medications/procedures and subject assessment of pruritus. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Difference in change from baseline in psoriatic infiltrate measured by ultrasound between CRx-197, nortriptyline, active comparator as well as vehicle of CRx-197 and untreated test field(s) [ Time Frame: Days 8, 15, 22, 29 and 43 ] [ Designated as safety issue: No ]
  • Difference in change from baseline in erythema measured by chronometry between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s) and normal skin [ Time Frame: Days 8, 15, 22, 29 and 43 ] [ Designated as safety issue: No ]
  • Modified PASI between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s) [ Time Frame: Baseline, and Days 8, 15, 22, 29 and 43 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CRx-197 high dose (0.1% nortriptyline HCl + 0.3% loratadine) Drug: nortriptyline HCl + loratadine
Topical
Experimental: CRx-197 low dose (0.1% nortriptyline HCl + 0.1% loratadine) Drug: nortriptyline HCl + loratadine
Topical
Experimental: 0.1% nortriptyline HCl Drug: nortriptyline HCl
Topical
Active Comparator: 0.1% mometasone furoate Drug: mometasone furoate
Topical
Placebo Comparator: Active ingredient free vehicle cream of CRx-197 Drug: Active ingredient free vehicle cream of CRx-197
Topical

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject must voluntarily sign and date the written Informed Consent prior to any study specific procedures
  • Subject must be 18 to 60 years of age
  • Subject must have healthy skin on which reddening can be easily recognized in the area where they will place the test fields
  • Subject must be free from a condition/disease that the investigator feels interferes with the interpretation of the study results.
  • Females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen. A highly effective method of birth control is defined as those which result in a lower failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner.

Exclusion Criteria:

  • Suntan, hyper- or hypo-pigmentation, or tattoos in the area where they will place 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 less than LLN, or subject receiving any thyroid medication
  • Severe liver disease - ALT laboratory value that exceeds 1.5x ULN
  • Inflammatory dermatoses (e.g., atopic dermatoses/eczema, psoriasis)
  • Any skin condition involving the test fields including but not limited to bacterial, viral, or fungal skin infections, acne, 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 treatments
  • Allergy to adhesives on the patches used for occlusion in the study
  • UV therapy or significant UV exposure in the four weeks before treatment application
  • 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 treatment application that may influence the outcome of the study
  • Positive for HIV antibody
  • Systemic treatments in the four weeks prior to treatment application that may interact with any of the study drugs, such as: Glucocorticoids, MAO inhibitors, anti-depressants, anti-seizure medications, anti-psychotics and anti-histamines
  • Subjects who require medications that inhibit the CYP450 2D6 pathway such as:Quinidine, Cimetidine, Type 1 anti-arrhythmic, Phenothiazines, Selective serotonin reuptake inhibitors, Reserpine, other anticholinergic drugs, and sympathomimetic drugs
  • Treatment with any investigational agent within one month before treatment application for this trial
  • Female subject who is pregnant , lactating, or with a positive pregnancy test
  • 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, 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: NCT00721331

Locations
Germany
PROINNOVERA GmbH
Muenster, Germany
Sponsors and Collaborators
Zalicus
Investigators
Principal Investigator: Jutta Harten, MD PROINNOVERA GmbH
  More Information

No publications provided

Responsible Party: James Keane, Sr. Clinical Project Manager, CombinatoRx, Inc.
ClinicalTrials.gov Identifier: NCT00721331     History of Changes
Other Study ID Numbers: CRx-197-001, EudraCT # 2008-000611-15
Study First Received: July 21, 2008
Last Updated: September 24, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Zalicus:
CombinatoRx
Atopic
Dermatitis
Topical
CRx-197
Normal Healthy Volunteers

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Loratadine
Mometasone furoate
Nortriptyline
Adrenergic Agents
Adrenergic Uptake Inhibitors
Anti-Allergic Agents
Anti-Inflammatory Agents
Antidepressive Agents
Antidepressive Agents, Tricyclic
Antipruritics
Central Nervous System Agents
Dermatologic Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014