Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single and Multiple Doses of LEO 142397 in Healthy People, Including Japanese
NCT ID: NCT03995550
Last Updated: 2025-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2019-07-03
2020-07-16
Brief Summary
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The trial consists of 2 parts:
* In Part 1, participants will receive a single dose of LEO 142397. There will be up to 8 different dose groups.
* In Part 2, participants will receive a daily dose of LEO 142397 for 14 days. There will be up to 6 different dose groups.
Each participant will be enrolled into 1 dose group in either Part 1 or Part 2.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Single ascending dose Cohort A
Single dose of LEO 142397 or placebo.
LEO 142397
A compound in development by LEO Pharma A/S
Placebo
Placebo
Single ascending dose Cohort B
Single dose of LEO 142397 or placebo.
LEO 142397
A compound in development by LEO Pharma A/S
Placebo
Placebo
Single ascending dose Cohort C
2 single doses, separated by a washout of ≥7 days.
LEO 142397
A compound in development by LEO Pharma A/S
Placebo
Placebo
Single ascending dose Cohort D
2 single doses, separated by a washout of ≥7 days.
LEO 142397
A compound in development by LEO Pharma A/S
Placebo
Placebo
Single ascending dose Cohort E
Single dose of LEO 142397 or placebo.
LEO 142397
A compound in development by LEO Pharma A/S
Placebo
Placebo
Single ascending dose Cohort F
Single dose of LEO 142397 or placebo.
LEO 142397
A compound in development by LEO Pharma A/S
Placebo
Placebo
Single ascending dose Cohort G
Single dose of LEO 142397 or placebo.
LEO 142397
A compound in development by LEO Pharma A/S
Placebo
Placebo
Single ascending dose Cohort H
Single dose of LEO 142397 or placebo - tentative, female-only cohort (to be included only if the number of women recruited in the remaining cohorts is insufficient to assess the pharmacokinetics of LEO 142397 in women). Dose level ≥ that in Cohort C and ≤ that in Cohort D.
LEO 142397
A compound in development by LEO Pharma A/S
Placebo
Placebo
Multiple ascending dose Cohort K
Multiple doses of LEO 142397 or placebo.
LEO 142397
A compound in development by LEO Pharma A/S
Placebo
Placebo
Multiple ascending dose Cohort L
Multiple doses of LEO 142397 or placebo.
LEO 142397
A compound in development by LEO Pharma A/S
Placebo
Placebo
Multiple ascending dose Cohort M
Multiple doses of LEO 142397 or placebo.
LEO 142397
A compound in development by LEO Pharma A/S
Placebo
Placebo
Multiple ascending dose Cohort N
Multiple doses of LEO 142397 or placebo.
LEO 142397
A compound in development by LEO Pharma A/S
Placebo
Placebo
Multiple ascending dose Cohort O
Multiple doses of LEO 142397 or placebo.
LEO 142397
A compound in development by LEO Pharma A/S
Placebo
Placebo
Multiple ascending dose Cohort P
Multiple doses of LEO 142397 or placebo in Japanese-only subjects. Same dose level as for Cohort M.
LEO 142397
A compound in development by LEO Pharma A/S
Placebo
Placebo
Interventions
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LEO 142397
A compound in development by LEO Pharma A/S
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* In good health at screening and check-in as judged by the investigator based on medical history, physical examination, vital signs assessment, 12-lead electrocardiogram, and clinical laboratory evaluations:
* Aspartate aminotransferase and alanine aminotransferase values ≤1.5 times the upper limit of normal.
* Congenital nonhaemolytic hyperbilirubinaemia (including suspicion of Gilbert's syndrome) is not acceptable.
* Haemoglobin value, neutrophil count, and lymphocyte count ≥ the lower limit of normal.
* Female subjects of childbearing potential must use a highly effective form of birth control, in conjunction with adequate barrier contraception, from randomisation until 90 days after the follow-up visit.
* Male subjects with female partner of childbearing potential must use adequate male barrier contraception, in conjunction with a highly effective form of female contraception for the partner, from randomisation until 90 days after the follow-up visit.
Exclusion Criteria
* Any medication, including St. John's wort, known to chronically alter drug absorption or elimination processes within 30 days prior to the first dose.
* History of any significant infectious disease, as assessed by the investigator, within 2 weeks prior to the first dose.
* Current active tuberculosis based on QuantiFERON-TB Gold test.
* Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibodies at screening.
* Electrocardiogram abnormalities at screening or check-in.
* Smoking of \>10 cigarettes per day, on average, within the last 3 months.
18 Years
65 Years
ALL
Yes
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Expert
Role: STUDY_DIRECTOR
LEO Pharma
Locations
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Covance Clinical Research Unit Ltd.
Leeds, , United Kingdom
Countries
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Other Identifiers
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2018-004470-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LP0184-1415
Identifier Type: -
Identifier Source: org_study_id
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