LEO 29102 Single and Multiple Dose Study by Dermal Application

This study has been completed.
Sponsor:
Information provided by:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00891709
First received: April 30, 2009
Last updated: January 29, 2010
Last verified: January 2010
  Purpose

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 male subjects.

The study is divided into one single dose part followed by a multiple dose part.


Condition Intervention Phase
Atopic Dermatitis
Drug: LEO 29102
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: A Phase 1, First in Man, Safety, Tolerability and Pharmacokinetic Study of Single Ascending and Multiple Cutaneous Doses of LEO 29102 2.5 mg/g Cream or LEO 29102 Cream Vehicle in Healthy Male Subjects

Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • To determine the safety and tolerability [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the pharmacokinetics [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
LEO 29102 2.5 mg/g cream
Drug: LEO 29102
First-in-man. Healthy volunteers
Placebo Comparator: 2
LEO 29102 cream vehicle
Drug: LEO 29102
First-in-man. Healthy volunteers

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male adults between the age of 18 and 55 years (both inclusive) and with a BMI between 19 and 30 kg/m2 (both inclusive).
  • Subjects must be healthy as determined by medical history, physical examination, electrocardiogram (ECG), blood pressuer and heart rate, and clinical laboratory evaluation.

Exclusion Criteria:

  • Subjects who show signs of eczema or other skin lesions.
  • Subjects who have any clinical signs of allergic diseases (excluding non active hay fever).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891709

Locations
United Kingdom
LCG Bioscience
Bourn, Cambridgeshire, United Kingdom, CB23 2TN
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Anthony Priestley, MBChB MFPM LCG Bioscience, Bourn Hall, Bourn, Cambridgeshire, CB23 2TN, UK
  More Information

No publications provided

Responsible Party: Pontus Hegardt, Clinical Trial Manager, LEO Pharma A/S
ClinicalTrials.gov Identifier: NCT00891709     History of Changes
Other Study ID Numbers: LEO 29102-C01
Study First Received: April 30, 2009
Last Updated: January 29, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on October 23, 2014