Safety, Tolerability and Pharmacokinetics in AD Subjects and Healthy Subjects of Cutaneous Application of LEO 39652 Cream

Atopic Dermatitis Clinical Trial

Official title:

A Phase I, First-in-Human, Vehicle Controlled, Single Ascending Dose Trial Evaluating the Safety, Tolerability and Pharmacokinetics in Male Subjects With AD and in Healthy Male Subjects of Cutaneous Application of LEO 39652 Cream

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850849
• Other study ID #: LP0083-1011
• Status: Completed
• Phase: Phase 1
• First received: May 7, 2013
• Last updated: January 21, 2015
• Start date: May 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The principle aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 39652 cream is administered cutaneously as single dose to subjects with atopic dermatitis and to healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy subjects or subjects with AD as defined by the Hanifen and Rajka criteria and with at least mild disease activity (IGA >2) for the whole body

• AD lesions amenable to cutaneous treatment located on the trunk and/or limbs (only for AD subjects)

• Male subjects aged between 18 and 65 years with a body mass index (BMI) between 19.0 and 32.0 kg/m2 inclusive

Exclusion Criteria:

• Subjects who currently suffer from, or show signs of eczema or other skin lesions (only for healthy subjects)

• Subjects who are still participating in a clinical trial (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational product or a marketed drug product within the past 3 months prior to the first dosing occasion.

• Subjects with known immunocompromised state due to treatment with immunosuppressive drugs or due to history of a disease leading to immunocompromised status.

• History of or current cardiac arrhythmic disorder

• Subjects with a current active malignancy or a history of malignancy in remission for less than 5 years except excised skin (not melanoma) and cervical cancer.

• Subjects who have any clinically significant allergic disease (excluding non- active hayfever) as determined by the Investigator

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• LEO 39652 cream

• cream vehicle

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit, Hyde Street, Leeds, UK	Leeds
United Kingdom	Covance Royal Liverpool Clinical Research Unit	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events and change from baseline in vital signs (blood pressure, pulse rate) ECG, clinical laboratory and local tolerability assessments		Up to 48 hours after dosing	Yes
Secondary	LEO 39652 and metabolites in blood		Up to 48 hours after dosing	Yes