NCT00891709

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

February 24, 2025

Status Verified

January 1, 2010

Enrollment Period

3 months

First QC Date

April 30, 2009

Last Update Submit

February 21, 2025

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • To determine the safety and tolerability

Secondary Outcomes (1)

  • To determine the pharmacokinetics

Study Arms (2)

1

EXPERIMENTAL

LEO 29102 2.5 mg/g cream

Drug: LEO 29102

2

PLACEBO COMPARATOR

LEO 29102 cream vehicle

Drug: LEO 29102

Interventions

LEO 29102DRUG

First-in-man. Healthy volunteers

12

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects who show signs of eczema or other skin lesions.
  • Subjects who have any clinical signs of allergic diseases (excluding non active hay fever).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LCG Bioscience

Bourn, Cambridgeshire, CB23 2TN, United Kingdom

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

2-(6-(2-(3,5-dichloro-4-pyridyl)acetyl)-2,3-dimethoxyphenoxy)-N-propylacetamide

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Anthony Priestley, MBChB MFPM

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2009

First Posted

May 1, 2009

Study Start

March 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

February 24, 2025

Record last verified: 2010-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)