Back to resultsLEO 32731 - A Phase I Study in Healthy Subjects
Primary Purpose
Psoriasis Vulgaris
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
LEO32731
Placebo
Sponsored by
About this trial
This is an interventional other trial for Psoriasis Vulgaris
Eligibility Criteria
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.
- 11. Subjects who are known to have serum hepatitis, or who are carriers of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody, or who have a positive result to the test for HIV antibodies.
- 12. Active tuberculosis or history of incompletely treated tuberculosis, based on medical history or medical report.
- 13. Subjects who, in the opinion of their General Practitioner (GP) or the Investigator, should not participate in the study.
- 14. Subjects with one or more positive faecal occult blood test (immunochemical method) out of 2 assessments at the time between screening and Day-1 check-in.
- 15. Subjects with ≥ 3 bowel movements/day.
- 16. Subjects who have previously taken part in or withdrawn from this study.
- 17. Subjects who, in the opinion of the Investigator, should not participate in the study.
Sites / Locations
- Covance CRU
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
LEO 32731
Placebo
Arm Description
Active
Placebo
Outcomes
Primary Outcome Measures
Safety reported as number of Participants with Adverse Events
Secondary Outcome Measures
Pharmacokinetics reported as area under the plasma concentration versus time curve (AUC)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02514694
Brief Title
LEO 32731 - A Phase I Study in Healthy Subjects
Official Title
LEO 32731 - A Phase I, Single-Blind, Placebo-Controlled, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEO 32731
Arm Type
Active Comparator
Arm Description
Active
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
LEO32731
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Safety reported as number of Participants with Adverse Events
Time Frame
16 days
Secondary Outcome Measure Information:
Title
Pharmacokinetics reported as area under the plasma concentration versus time curve (AUC)
Time Frame
16 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
11. Subjects who are known to have serum hepatitis, or who are carriers of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody, or who have a positive result to the test for HIV antibodies.
12. Active tuberculosis or history of incompletely treated tuberculosis, based on medical history or medical report.
13. Subjects who, in the opinion of their General Practitioner (GP) or the Investigator, should not participate in the study.
14. Subjects with one or more positive faecal occult blood test (immunochemical method) out of 2 assessments at the time between screening and Day-1 check-in.
15. Subjects with ≥ 3 bowel movements/day.
16. Subjects who have previously taken part in or withdrawn from this study.
17. Subjects who, in the opinion of the Investigator, should not participate in the study.
Facility Information:
Facility Name
Covance CRU
City
Leeds
ZIP/Postal Code
LS2 9LH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
LEO 32731 - A Phase I Study in Healthy Subjects
We'll reach out to this number within 24 hrs