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Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects by Dermal Application of a LEO 29102

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ClinicalTrials.gov Identifier: NCT01423656
Recruitment Status : Completed
First Posted : August 26, 2011
Last Update Posted : January 28, 2013
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

July 14, 2011
August 26, 2011
January 28, 2013
August 2011
November 2012   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01423656 on ClinicalTrials.gov Archive Site
LEO 29102 and metabolites in blood and urine [ Time Frame: 72 hours after dosing ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects by Dermal Application of a LEO 29102
Not Provided

The principal aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 29102 is administered cutaneously as single and multiple doses to healthy subjects.

The study is divided into one single dose part, one part to compare pharmacokinetics between gender and one multiple dose part.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Atopic Dermatitis
  • Drug: LEO 29102
  • Drug: Placebo
    Placebo Comparator: LEO 29102 vehicle
  • Experimental: LEO 29102
    Intervention: Drug: LEO 29102
  • Placebo Comparator: LEO 29102 vehicle
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
72
November 2012
November 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01423656
LEO 29102-C06
No
Not Provided
Not Provided
LEO Pharma
LEO Pharma
Not Provided
Principal Investigator: Ashley Brooks, MBChB Covance
LEO Pharma
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP