Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single and Multiple Doses of LEO 142397 in Healthy People, Including Japanese
- Registration Number
- NCT03995550
- Lead Sponsor
- LEO Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single ascending dose Cohort A LEO 142397 Single dose of LEO 142397 or placebo. Single ascending dose Cohort A Placebo Single dose of LEO 142397 or placebo. Single ascending dose Cohort B LEO 142397 Single dose of LEO 142397 or placebo. Single ascending dose Cohort B Placebo Single dose of LEO 142397 or placebo. Single ascending dose Cohort C LEO 142397 2 single doses, separated by a washout of ≥7 days. Single ascending dose Cohort C Placebo 2 single doses, separated by a washout of ≥7 days. Single ascending dose Cohort D LEO 142397 2 single doses, separated by a washout of ≥7 days. Single ascending dose Cohort D Placebo 2 single doses, separated by a washout of ≥7 days. Single ascending dose Cohort E LEO 142397 Single dose of LEO 142397 or placebo. Single ascending dose Cohort E Placebo Single dose of LEO 142397 or placebo. Single ascending dose Cohort F Placebo Single dose of LEO 142397 or placebo. Single ascending dose Cohort G Placebo Single dose of LEO 142397 or placebo. Single ascending dose Cohort H LEO 142397 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. Single ascending dose Cohort H Placebo 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. Multiple ascending dose Cohort K LEO 142397 Multiple doses of LEO 142397 or placebo. Multiple ascending dose Cohort K Placebo Multiple doses of LEO 142397 or placebo. Multiple ascending dose Cohort L LEO 142397 Multiple doses of LEO 142397 or placebo. Multiple ascending dose Cohort L Placebo Multiple doses of LEO 142397 or placebo. Multiple ascending dose Cohort M Placebo Multiple doses of LEO 142397 or placebo. Multiple ascending dose Cohort N LEO 142397 Multiple doses of LEO 142397 or placebo. Multiple ascending dose Cohort N Placebo Multiple doses of LEO 142397 or placebo. Multiple ascending dose Cohort O LEO 142397 Multiple doses of LEO 142397 or placebo. Multiple ascending dose Cohort O Placebo Multiple doses of LEO 142397 or placebo. Multiple ascending dose Cohort P LEO 142397 Multiple doses of LEO 142397 or placebo in Japanese-only subjects. Same dose level as for Cohort M. Multiple ascending dose Cohort P Placebo Multiple doses of LEO 142397 or placebo in Japanese-only subjects. Same dose level as for Cohort M. Single ascending dose Cohort G LEO 142397 Single dose of LEO 142397 or placebo. Single ascending dose Cohort F LEO 142397 Single dose of LEO 142397 or placebo. Multiple ascending dose Cohort M LEO 142397 Multiple doses of LEO 142397 or placebo.
- Primary Outcome Measures
Name Time Method 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 2. Number of treatment-emergent adverse events per subject From Day 1 (postdose) up to Day 21 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. 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Covance Clinical Research Unit Ltd.
🇬🇧Leeds, United Kingdom