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LEO 32731 - A Study in Healthy Male Subjects

NCT01310049 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2013-11-05

No results posted yet for this study

Summary

The purpose of this first-in-man trial is to determine the safety and tolerability of ascending single and multiple doses of LEO 32731 in healthy male subjects. The trial will be performed in three parts. In Part 1, single doses of LEO 32731 will be administered to healthy male subjects. In Part 2, the effect of food on the single oral dose pharmacokinetic will be investigated. In Part 3, multiple doses of LEO 32731 will be administered to healthy male subjects.

Conditions

  • Healthy Subjects

Interventions

DRUG

LEO 32731

* Part 1 and 2: Oral single dose of oral solution or capsule * Part 3: Twice daily dose of oral solution or capsule for 7 days

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Joseph Chiesa, MD · Covance

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-08-31
Completion
2012-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01310049 on ClinicalTrials.gov