Healthy
Conditions
Brief summary
This is the first clinical trial with LEO 142397. The purpose of the trial is to assess the safety and tolerability of LEO 142397, along with the pharmacokinetics (what the body does to the drug) and the pharmacodynamics (what the drug does to the body) in healthy people. 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.
Interventions
DRUGLEO 142397
A compound in development by LEO Pharma A/S
DRUGPlacebo
Placebo
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1. Number of treatment-emergent adverse events per subject | From Day 1 (postdose) up to Day 8 | — |
| Part 1. Having clinically significant abnormalities in systolic blood pressure | From Day 1 (postdose) up to Day 8 | Clinical significance (yes/no) of abnormal values as judged by the investigator |
| Part 1. Having clinically significant abnormalities in diastolic blood pressure | From Day 1 (postdose) up to Day 8 | Clinical significance (yes/no) of abnormal values as judged by the investigator |
| Part 1. Having clinically significant abnormalities in heart rate | From Day 1 (postdose) up to Day 8 | Clinical significance (yes/no) of abnormal values as judged by the investigator |
| Part 1. Having clinically significant abnormalities in oral body temperature | From Day 1 (postdose) up to Day 8 | Clinical significance (yes/no) of abnormal values as judged by the investigator |
| Part 1. Having an abnormal ECG | From Day 1 (postdose) up to Day 8 | ECG: electrocardiogram. Abnormal ECG (yes/no) defined as: QT interval corrected for heart rate using Fridericia's formula (QTcF) of \>450 msec for males / \>470 msec for females, or change from baseline of \>30 msec |
| Part 2. Number of treatment-emergent adverse events per subject | From Day 1 (postdose) up to Day 21 | — |
| Part 2. Having clinically significant abnormalities in systolic blood pressure | From Day 1 (postdose) up to Day 21 | Clinical significance (yes/no) of abnormal values as judged by the investigator |
| Part 2. Having clinically significant abnormalities in diastolic blood pressure | From Day 1 (postdose) up to Day 21 | Clinical significance (yes/no) of abnormal values as judged by the investigator |
| Part 2. Having clinically significant abnormalities in heart rate | From Day 1 (postdose) up to Day 21 | Clinical significance (yes/no) of abnormal values as judged by the investigator |
| Part 2. Having clinically significant abnormalities in oral body temperature | From Day 1 (postdose) up to Day 21 | Clinical significance (yes/no) of abnormal values as judged by the investigator |
| Part 2. Having an abnormal ECG | From Day 1 (postdose) up to Day 21 | ECG: electrocardiogram. Abnormal ECG (yes/no) defined as: QT interval corrected for heart rate using Fridericia's formula (QTcF) of \>450 msec for males / \>470 msec for females, or maximum change from baseline of \>30 msec |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1. AUC0-∞ | Derived from plasma concentration-time profile from 0-48 hours postdose | AUC0-∞: area under the plasma concentration-time curve from time zero to infinity |
| Part 1. Cmax | Derived from plasma concentration-time profile from 0-48 hours postdose | Cmax: maximum plasma concentration |
| Part 2. Accumulation ratio | Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14 | — |
| Part 2. AUC0-24 | Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14 | AUC0-24: area under the plasma concentration-time curve from time zero to 24 hours postdose |
| Part 2. Cmax | Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14 | Cmax: maximum plasma concentration |
Countries
United Kingdom
Contacts
STUDY_DIRECTORMedical Expert
LEO Pharma
Outcome results
None listed