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LEO 32731 - A Phase I Study in Healthy Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

LEO 32731 - A Phase I Study in Healthy Subjects

LEO 32731 - A Phase I, Single-Blind, Placebo-Controlled, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects

NCT02514694•LEO Pharma

View on ClinicalTrials.gov

Summary

LEO 32731 ("Study Drug") is an investigational drug which is being developed by LEO Pharma A/S ("the Sponsor") for treatment of psoriasis. The aim (s) of this Study are to determine: * The safety and tolerability of the Study Drug and any side effects that might be associated with it * The Study will also measure how much of the Study Drug that gets into the blood and how long time it takes for the body to remove it.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1\. Subjects will, prior to any study related activities, have given their written informed consent to participate in the study and to abide by the study restrictions.
•2\. Subjects will be males or females of non-childbearing potential between 18 and 55 years of age.
•3\. Subjects will have a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive.
•4\. For Group C, subjects will be women of non-childbearing potential.
•5\. Subjects must be in good health.

Exclusion Criteria

•1\. Male subjects who are not willing, or whose partners are not willing, to use appropriate contraception.
•2\. Subjects who have received any prescribed systemic or topical medication within 14 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
•3\. Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
•4\. Subjects who have received any medications, including St John's Wort (or other dietary restriction, Section 6.2.3), known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
•5\. Subjects with a significant history of drug allergy as determined by the Investigator.
•6\. Subjects who have any clinically significant allergic disease (excluding non-active hayfever) as determined by the Investigator.
•7\. Subjects who have a supine blood pressure and supine pulse rate at screening higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 50 bpm, respectively.
•8\. Subjects with a positive urine drug screen or alcohol breath test result at screening or first admission.
•9\. Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, dermatological or other major disorders as determined by the Investigator.
•10\. Subjects who have had a clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator.
+7 more criteria

Locations (1)

Covance CRU

Leeds, United Kingdom

Key Dates

Start Date

July 1, 2015

Primary Completion Date

December 1, 2015

Completion Date

December 1, 2015

Last Updated

May 3, 2017

Enrollment

ACTUAL participants

Conditions

Psoriasis Vulgaris

Interventions

LEO32731

DRUG

Placebo

OTHER

Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)

NCT04080635

Psoriasis Vulgaris

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COMPLETEDPHASE4

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

NCT04340076

PsoriasisPsoriasis Vulgaris

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WITHDRAWNNA

Safety and Effectiveness of Combined LED Light for the Treatment of Mild to Moderate Plaque Type Psoriasis Vulgaris

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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LEO 32731 - A Phase I Study in Healthy Subjects

Inclusion Criteria

Exclusion Criteria

Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

Safety and Effectiveness of Combined LED Light for the Treatment of Mild to Moderate Plaque Type Psoriasis Vulgaris

Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP

A Pilot Study to Explore the Role of Gut Flora in Psoriasis

The Mediterranean Diet and Time-Restricted Eating Dietary Interventions for Psoriasis Study