Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects by Dermal Application of a LEO 29102
1 other identifier
interventional
102
1 country
1
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 subjects. The study is divided into one single dose part, one part to compare pharmacokinetics between gender and one multiple dose part.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2011
1 active site
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
First Submitted
Initial submission to the registry
July 14, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedFirst Posted
Study publicly available on registry
August 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedFebruary 24, 2025
January 1, 2013
1.3 years
July 14, 2011
February 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
7 days after last dosing
Secondary Outcomes (1)
LEO 29102 and metabolites in blood and urine
72 hours after dosing
Study Arms (2)
LEO 29102
EXPERIMENTALLEO 29102 vehicle
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LEO Pharmalead
Study Sites (1)
Covance Clinical Research Unit Ltd.
Leeds, LS2 9LH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashley Brooks, MBChB
Covance
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2011
First Posted
August 26, 2011
Study Start
August 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
February 24, 2025
Record last verified: 2013-01
Data Sharing
- IPD Sharing
- Will not share