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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 30, 2009

Last Updated Date

January 29, 2010

Start Date ^ICMJE

March 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determine the safety and tolerability [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00891709 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To determine the pharmacokinetics [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

LEO 29102 Single and Multiple Dose Study by Dermal Application

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Condition ^ICMJE

Atopic Dermatitis

Intervention ^ICMJE

Drug: LEO 29102

First-in-man. Healthy volunteers

Study Arm (s)

Experimental: 1
LEO 29102 2.5 mg/g cream

Intervention: Drug: LEO 29102
Placebo Comparator: 2
LEO 29102 cream vehicle

Intervention: Drug: LEO 29102

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Male

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00891709

Other Study ID Numbers ^ICMJE

LEO 29102-C01

Has Data Monitoring Committee

Responsible Party

Pontus Hegardt, Clinical Trial Manager, LEO Pharma A/S

Study Sponsor ^ICMJE

LEO Pharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Anthony Priestley, MBChB MFPM

LCG Bioscience, Bourn Hall, Bourn, Cambridgeshire, CB23 2TN, UK

Information Provided By

LEO Pharma

Verification Date

January 2010

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

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