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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
A compound in development by LEO Pharma A/S
Placebo
Covance Clinical Research Unit Ltd.
Leeds, United Kingdom
Part 1. Number of treatment-emergent adverse events per subject
Time frame: From Day 1 (postdose) up to Day 8
Part 1. Having clinically significant abnormalities in systolic blood pressure
Clinical significance (yes/no) of abnormal values as judged by the investigator
Time frame: From Day 1 (postdose) up to Day 8
Part 1. Having clinically significant abnormalities in diastolic blood pressure
Clinical significance (yes/no) of abnormal values as judged by the investigator
Time frame: From Day 1 (postdose) up to Day 8
Part 1. Having clinically significant abnormalities in heart rate
Clinical significance (yes/no) of abnormal values as judged by the investigator
Time frame: From Day 1 (postdose) up to Day 8
Part 1. Having clinically significant abnormalities in oral body temperature
Clinical significance (yes/no) of abnormal values as judged by the investigator
Time frame: From Day 1 (postdose) up to Day 8
Part 1. Having an abnormal ECG
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
Time frame: From Day 1 (postdose) up to Day 8
Part 2. Number of treatment-emergent adverse events per subject
Time frame: From Day 1 (postdose) up to Day 21
Part 2. Having clinically significant abnormalities in systolic blood pressure
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Clinical significance (yes/no) of abnormal values as judged by the investigator
Time frame: From Day 1 (postdose) up to Day 21
Part 2. Having clinically significant abnormalities in diastolic blood pressure
Clinical significance (yes/no) of abnormal values as judged by the investigator
Time frame: From Day 1 (postdose) up to Day 21
Part 2. Having clinically significant abnormalities in heart rate
Clinical significance (yes/no) of abnormal values as judged by the investigator
Time frame: From Day 1 (postdose) up to Day 21
Part 2. Having clinically significant abnormalities in oral body temperature
Clinical significance (yes/no) of abnormal values as judged by the investigator
Time frame: From Day 1 (postdose) up to Day 21
Part 2. Having an abnormal ECG
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
Time frame: From Day 1 (postdose) up to Day 21
Part 1. AUC0-∞
AUC0-∞: area under the plasma concentration-time curve from time zero to infinity
Time frame: Derived from plasma concentration-time profile from 0-48 hours postdose
Part 1. Cmax
Cmax: maximum plasma concentration
Time frame: Derived from plasma concentration-time profile from 0-48 hours postdose
Part 2. Accumulation ratio
Time frame: Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14
Part 2. AUC0-24
AUC0-24: area under the plasma concentration-time curve from time zero to 24 hours postdose
Time frame: Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14
Part 2. Cmax
Cmax: maximum plasma concentration
Time frame: Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14