LEO Pharma's new drug study pulled before any volunteers enrolled
NCT ID NCT03995550
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This was an early-stage study designed to check the safety and tolerability of a new drug called LEO 142397 in healthy people. The study was planned in two parts: one group would get a single dose, and another would take it daily for two weeks. However, the study was withdrawn before any participants were enrolled, so no results are available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Started
-
Jul 2019
- Finished
-
Jul 2020
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key inclusion Criteria: * Body mass index of 18.0-32.0 kg/m2, inclusive. * 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. Key exclusion criteria: * Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of any drug. * 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Covance Clinical Research Unit Ltd.
Leeds, LS2 9LH, United Kingdom
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