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Sponsored by: |
LEO Pharma |
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Information provided by: | LEO Pharma |
ClinicalTrials.gov Identifier: | NCT00833872 |
The purpose of this first-in-man trial is to determine the safety and tolerability of ascending single and multiple doses of LEO 22811 in healthy male subjects as well as to determine the safety and tolerability of single oral doses of LEO 22811 in healthy female subjects. The trial will be performed in two parts. In Part 1, single doses of LEO 22811 will be administered to healthy male and female subjects. In Part 2, multiple doses of LEO 22811 will be administered to healthy male subjects.
Condition | Intervention | Phase |
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Psoriasis Vulgaris |
Drug: LEO 22811 |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Investigator), Placebo Control |
Official Title: | LEO 22811 - A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects |
Estimated Enrollment: | 56 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria: (in summary)
Exclusion Criteria: (in summary)
Contact: Rikke L Fischer, PhD | +45 4494 5888 | rikke.fischer@leo-pharma.com |
Contact: Anders N Hansen, MSc Pharm | +45 4494 5888 | anders.hansen@leo-pharma.com |
United Kingdom | |
Covance Clinical Research Unit Ltd | Recruiting |
Leeds, United Kingdom, LS2 9LH | |
Contact: Douglas Lee +44 113 237 3500 douglas.lee@covance.com | |
Principal Investigator: Douglas Lee |
Principal Investigator: | Douglas Lee | Covance Clinical Research Unit Ltd |
Responsible Party: | LEO Pharma ( Rikke Lykke Fischer, Clinical Trial Manager ) |
Study ID Numbers: | LEO 22811-S21 |
Study First Received: | January 30, 2009 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00833872 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Skin Diseases Psoriasis Healthy Skin Diseases, Papulosquamous |
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |