Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Shionogi USA, Inc. |
---|---|
Information provided by: | Shionogi USA, Inc. |
ClinicalTrials.gov Identifier: | NCT00697710 |
Study consists of three successive cohorts of 12-16 patients with atopic dermatitis treated for 14 days:
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 |
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 |
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
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Use of adequate birth control, if of reproductive potential and sexually active.
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
Exclusion Criteria:
Presence of comorbid conditions that would preclude participation in the study, including:
Subject has
14 Any reason which, in the opinion of the investigator, interferes with the ability of the subject to participate to, or complete, the trial.
United States, Florida | |
Comprehensive Phase One | |
Miramar, Florida, United States, 33025 |
Study Director: | Richard A Paul, MD | Shionogi USA, Inc. |
Principal Investigator: | Maria J Gutierrez, MD | Comprehensive Phase One |
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 |
Atopic Dermatitis |
Hypersensitivity Dermatitis, Atopic Genetic Diseases, Inborn Skin Diseases |
Hypersensitivity, Immediate Skin Diseases, Eczematous Skin Diseases, Genetic Dermatitis |
Immune System Diseases |