LEO 22811 - A Phase 1, Double-Blind, Placebo-controlled, Single and Multiple Oral Dose Study in Healthy Subjects - Full Text View

Purpose

The purpose of this first-in-man trial is to determine the safety and tolerability of ascending single and multiple doses of LEO 22811 in healthy male subjects as well as to determine the safety and tolerability of single oral doses of LEO 22811 in healthy female subjects. The trial will be performed in two parts. In Part 1, single doses of LEO 22811 will be administered to healthy male and female subjects. In Part 2, multiple doses of LEO 22811 will be administered to healthy male subjects.

Condition	Intervention	Phase
Psoriasis Vulgaris	Drug: LEO 22811	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator)
Official Title:	LEO 22811 - A Phase I, Double-Blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects

Further study details as provided by LEO Pharma:

Primary Outcome Measures:

To determine the safety and tolerability of ascending single and multiple oral doses of LEO 22811 in healthy male subjects. [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
To determine the safety and tolerability of single oral doses of LEO 22811 in healthy female subjects. [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]


Enrollment:	58
Study Start Date:	January 2009
Study Completion Date:	November 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LEO 22811 solution	Drug: LEO 22811 First-in-man
Placebo Comparator: placebo solution

Eligibility


Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria: (in summary)

Subjects will be Caucasian males or females of non-child bearing potential between 18 and 65 years of age
Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions

Exclusion Criteria: (in summary)

Women of childbearing potential
Subjects with an infectious illness within 3 days prior to dosing
Subjects with a history of tuberculosis
Subjects who have received any prescribed systemic or topical medication (including natural/herbal medicines) within 14 days of the first dose administration
Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration
In Part 2, subjects who have received or been exposed to Cloroquine products, endoxan, or any immunomodulating agent (e.g. azathioprin) within one month prior to the start of dosing
Subjects who are participating in a clinical study
Subjects with a significant history of drug allergy or with a known or suspected hypersensitivity to any of the components of LEO 22811 as determined by the Investigator
Subjects who have any clinically significant allergic disease (excluding non-active hayfever) as determined by the Investigator
Subjects who have a supine blood pressure and supine pulse rate at screening higher than 150/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/40 mmHg and 50 bpm, respectively
Subjects who have PR interval >= 200 ms, QTc(b) interval >450 ms (males) or > 470 ms (females), or who exhibit U waves of atrio-ventricular blocks at screening, based on 12-lead ECGs
Subjects who consume more than 28 units (males) or more than 21 units (females) of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse
Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
Subjects with a significant cardiac history (e.g. heart failure, hypokalemia, long QT syndrome)
Subjects who have had a clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator
Subjects who, in the opinion of their General Practitioner (GP) or the Investigator, should not participate in the study, including subjects suspected for whatever reason of not being able to comply with the requirements of the protocol

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833872

Locations


United Kingdom
Covance Clinical Research Unit Ltd
Leeds, United Kingdom, LS2 9LH

Sponsors and Collaborators

LEO Pharma

Investigators


Principal Investigator:	Douglas Lee	Covance Clinical Research Unit Ltd.

More Information

No publications provided


Responsible Party:	LEO Pharma
ClinicalTrials.gov Identifier:	NCT00833872 History of Changes
Other Study ID Numbers:	LEO 22811-S21
Study First Received:	January 30, 2009
Last Updated:	December 10, 2013
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on March 02, 2015