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

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ClinicalTrials.gov Identifier: NCT00833872
Recruitment Status : Completed
First Posted : February 2, 2009
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: LEO 22811 Drug: placebo solution Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : November 2009
Arms and Interventions
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Arm Intervention/treatment
Experimental: LEO 22811 solution Drug: LEO 22811
First-in-man
Placebo Comparator: placebo solution Drug: placebo solution


Outcome Measures
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Primary Outcome Measures :
  1. To determine the safety and tolerability of ascending single and multiple oral doses of LEO 22811 in healthy male subjects. [ Time Frame: 4 days ]
  2. To determine the safety and tolerability of single oral doses of LEO 22811 in healthy female subjects. [ Time Frame: 4 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
More Information
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00833872     History of Changes
Other Study ID Numbers: LEO 22811-S21
First Posted: February 2, 2009    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Pharmaceutical Solutions