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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01423656 |
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Date of registration:
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14/07/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects by Dermal Application of a LEO 29102
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Scientific title:
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Date of first enrolment:
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August 2011 |
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Target sample size:
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102 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01423656 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
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Phase:
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Phase 1
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Ashley Brooks, MBChB |
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Address:
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Telephone:
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Email:
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Affiliation:
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Covance Clinical Research Unit Ltd. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects will be Caucasian males and females between 18 and 55 years of age and with
a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive.
- Subjects must be in good health, as determined by a medical history, physical
examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations
Exclusion Criteria:
- Subjects who suffer from, or show signs of eczema or other skin lesions.
- Subjects who are still participating in a clinical study (e.g. attending follow-up
visits) or who have participated in a clinical study involving administration of an
investigational drug (new chemical entity), or a marketed drug within the past 3
months prior to the first dosing occasion.
- Subjects with a significant history of drug allergy as determined by the
Investigator.
- Subjects with known immunocompromised state due to treatment with immunosuppressive
drugs or due to history of a disease leading to immunocompromised status.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atopic Dermatitis
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Intervention(s)
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Drug: LEO 29102
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Drug: Placebo
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Primary Outcome(s)
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Number of subjects with adverse events (AEs) and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate and oral body temperature), ECG, telemetry,clinical laboratory and local tolerability assessments
[Time Frame: 7 days after last dosing]
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Secondary Outcome(s)
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LEO 29102 and metabolites in blood and urine
[Time Frame: 72 hours after dosing]
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Secondary ID(s)
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LEO 29102-C06
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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