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Safety Study of S-777469 in Subjects With Mild to Moderate Atopic Dermatitis
This study has been completed.
Sponsored by: Shionogi USA, Inc.
Information provided by: Shionogi USA, Inc.
ClinicalTrials.gov Identifier: NCT00697710
  Purpose

Study consists of three successive cohorts of 12-16 patients with atopic dermatitis treated for 14 days:

  • Cohort A: 50 mg BID of S-777469 or placebo
  • Cohort B: 200 mg BID of S-777469 or placebo
  • Cohort C: 800 mg BID of S-777469 or placebo

The primary objective of the study is to evaluate the safety/ tolerability and pharmacokinetics of S-777469.


Condition Intervention Phase
Atopic Dermatitis
Drug: S-777469
Phase I
Phase II

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety Study
Official Title: A Phase Ib/IIa Multiple-Dose, Double Blind, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmakokinetics and Pharmacodynamics of S-777469 in Subjects With Mild to Moderate Atopic Dermatitis

Further study details as provided by Shionogi USA, Inc.:

Primary Outcome Measures:
  • Safety, assessed by vital signs, physical exam, ECG, standard clinical labs
  • Pharmacokinetics

Enrollment: 38
Study Start Date: July 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
50 mg BID
Drug: S-777469
S-777469 50 mg BID
2: Experimental
200 mg BID
Drug: S-777469
S-777469 200 mg BID
3: Experimental
800 mg BID
Drug: S-777469
S-777469 800 mg BID
4: Placebo Comparator
Placebo
Drug: S-777469
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Otherwise healthy males and females between 18 and 65 years of age at the time of obtaining the written Informed Consent.
  2. Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
  3. Subject satisfies the diagnostic criteria for mild to moderate AD as judged by the Physician's Global Assessment Score and modified criteria as listed in Section 3.1, "Criteria for Diagnosis."
  4. Subject is judged to be in general good health based on medical history, physical examination (PE), and routine laboratory tests performed at Screen and Baseline, with the exception of diagnosis of mild to moderate AD.
  5. Subject has a negative laboratory results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) (anti-HCV antibodies), and Human Immunodeficiency Virus (HIV) antibody screens.
  6. Female subjects have a negative pregnancy test at Screen and Baseline.
  7. Serum creatinine in the normal range [0.5 to 1.5 mg/dL].
  8. Liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], and gamma glutamyl transpeptidase [GGT]) within normal range.
  9. Negative screen for drugs of abuse at Screen and Baseline.
  10. Subject agrees to refrain from smoking for the duration of the trial.
  11. Subject has no clinically significant abnormality on Screening or Baseline electrocardiogram (ECG). Inclusion of a subject with any ECG abnormality at Screening or Baseline must be jointly agreed upon by both Study Investigator and Sponsor to be not clinically relevant within the context of the study, prior to enrollment.
  12. Use of adequate birth control, if of reproductive potential and sexually active.

    • Adequate birth control is defined as agreement to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 1 additional month after last administration/dose of study drug
    • For females, adequate birth control methods will be defined as: oral contraceptives, intrauterine device or double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam.
    • For males adequate birth control methods will be defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam.
    • For female subjects, menopause is defined as one year without menses; if in question, a follicle-stimulating hormone (FSH) of >40 U/mL must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable.
  13. Subject has NOT used any topical or systemic treatments for AD for 3 weeks prior to the Day 1 visit (i.e., the Washout Period), including

    • topical corticosteroids (3 weeks prior to the Day 1 visit),
    • antihistamines (3 weeks prior to the Day 1 visit),
    • herbal preparation, cosmetic or emollient preparations (3 weeks prior to the Day 1 visit),
    • immunosuppressant drugs or corticosteroids (3 weeks prior to the Day 1 visit),
    • any other AD treatments (including light treatment) for 3 weeks prior to the Day 1 visit
  14. Subject is willing to completely avoid the use of any prescription or nonprescription (including over the counter [OTC]) drugs or any topical preparations [other than those topical emollient preparations provided by the study site during Screening, e.g., Cetaphil® cream] for 3 weeks prior to the first dose of study drug and during the entire study.
  15. If a subject does not discontinue all prior medications within 3 weeks of study start, he/she may be included in the study only if both the Study Investigator and Sponsor's Medical Monitor agree that this is not clinically relevant within the context of the study.
  16. Use of hormone replacement therapy (for postmenopausal females) and/or use of oral, implantable, transdermal, or injectable contraceptive(s) will be allowed.
  17. Subject is willing to avoid strenuous physical activity (i.e., strenuous or unaccustomed weight lifting, running, exercise, etc.) from the screening visit, throughout the study, and until the post-study Follow-up visit.
  18. Subject is willing to avoid grapefruit-containing products/medications for 72 hours prior to entry into the CRU and for the duration of the study.
  19. Subject has no history of frequent or recent acetaminophen use and is willing to refrain from use of acetaminophen throughout the trial and for four days after the last dose.

Exclusion Criteria:

  1. Subject is under the age of legal consent (see inclusion criteria), is mentally or legally incapacitated, has significant emotional problems at the time of Study Entry, or has a history of psychiatric disorders.
  2. Active dermatologic conditions which may confound the diagnosis of AD, such as scabies, allergic contact dermatitis, seborrheic dermatitis, cutaneous lymphoma, ichthyosis, or psoriasis.
  3. History of malignancy not in remission for >5 years.
  4. Presence of comorbid conditions that would preclude participation in the study, including:

    • Immune compromised state, including recent chemotherapy, immunotherapy, or organ transplant.
    • History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal or urological.
    • History or clinical manifestations of significant neurological or psychiatric disorders.
    • Subject has an active, intercurrent infection.
    • Subject has a history of clinically significant hypersensitivity, anaphylaxis, or allergies to any drug compound.
    • In no circumstances should a subject who did not qualify under inclusion criteria number 4 regarding Liver Function Tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST]. And gamma glutamyl transpeptidase [GGT]) be re-screened and/or re-qualified for this study.
  5. Subject has any acute or chronic condition or prior therapy that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study or otherwise would make the subject unsuitable for this study.
  6. Subject has a history of drug abuse within 1 year prior to Day 1.
  7. Subject consumes excess amounts of alcohol, defined as exceeding an average of 14 drinks/week (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor, or any combination of them) within 2 months prior to Study Entry, or is unwilling to comply with the restricted use of alcohol from screening, throughout the study, and until study completion (post-study visit).
  8. Subject has used any systemic antibiotics for 3 weeks prior to the Day 1 visit (Washout Period).
  9. Subject is pregnant or lactating or intends to become pregnant or, in the case of a male subject, intends to father a child during the study period and for 1 month after the last dose of study medication.
  10. Subject requires use of immunosuppressive drugs such as oral corticosteroids or inhaled corticosteroids.
  11. Subject has

    • donated blood within 6 weeks prior to Day 1 or plasma within 2 weeks prior to Screening, or
    • received blood products within 2 months prior to Day 1.
  12. Subject has poor peripheral venous access.
  13. Subject has participated in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to Day 1.

14 Any reason which, in the opinion of the investigator, interferes with the ability of the subject to participate to, or complete, the trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697710

Locations
United States, Florida
Comprehensive Phase One
Miramar, Florida, United States, 33025
Sponsors and Collaborators
Shionogi USA, Inc.
Investigators
Study Director: Richard A Paul, MD Shionogi USA, Inc.
Principal Investigator: Maria J Gutierrez, MD Comprehensive Phase One
  More Information

Responsible Party: Comprehensive Phase One ( M.J. Gutierrez, MD )
Study ID Numbers: 0710D1416
Study First Received: June 11, 2008
Last Updated: June 13, 2008
ClinicalTrials.gov Identifier: NCT00697710  
Health Authority: United States: Food and Drug Administration

Keywords provided by Shionogi USA, Inc.:
Atopic Dermatitis

Study placed in the following topic categories:
Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009