A Trial to Evaluate the Effect of Food on LEO 152020

Study Overview
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Brief Summary
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A phase 1 trial in healthy people to evaluate the food effect on LEO 152020 in an open-label design using film-coated tablets

Detailed Description
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This trial will evaluate the pharmacokinetics and tolerability of 2 single doses of film-coated tablets in the morning after fasting or after a high-fat breakfast. The 2 doses will be separated by a washout period.

Official Title
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A Phase 1, Randomised, Oral Dose Trial to Evaluate the Effect of Food on LEO 152020 in Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LEO 152020 Tablet


Participation Criteria
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Eligibility Criteria
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Key inclusion Criteria: Body mass index (BMI) between 18.0-32.0 kg/m2 (both 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 ECG, and clinical laboratory evaluations. Pulse rate of 50 to 100 bpm at screening, or with minor deviations judged to be acceptable by the investigator Females of child bearing potential and male subjects whose partners are of child-bearing potential must also agree to use an additional effective method of contraception. Key exclusion Criteria: Subjects who do not, or whose partners do not agree to use effective method(s) of contraception from the time of the first dose until 3 months (90 days) after the final dose. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. History of any significant infectious disease within 2 weeks prior to drug administration as assessed by the investigator. Subjects who have received any medication within 14 days of the first dose administration, except for hormonal contraception. Subjects who are still participating in a clinical trial (e.g. attending follow-up visits) or who have participated in a clinical trial involving administration of an investigational drug (new chemical entity), or a marketed drug within the past 3 months prior to the first dose. ECG abnormalities at screening or check-in Heart rate of <50 or >100 beats per minute, unless the investigator judges the subject to be eligible for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Single dose, cross-over with food effect
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fed<br>Single oral dose given after a full breakfast | Drug: LEO 152020 Tablet<br>* film-coated tablet<br>|
| Experimental: Fasting<br>Single oral dose given in fasting state | Drug: LEO 152020 Tablet<br>* film-coated tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum observed plasma concentration | pre-dose to 48 hours of each treatment period (Day 1 and Day 8) | 
| AUC (0 to infinity) | Area under the plasma concentration time curve (AUC) from time 0 extrapolated to infinity (AUC0 inf) | pre-dose to 48 hours of each treatment period (Day 1 and Day 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of total adverse events (AEs) and number of subjects with AEs at each combination of treatment and period | Number of AEs per subject at each combination of treatment and in total | Baseline to Day 10 | 
| Number of subjects with clinically relevant changes in vital signs (resting blood pressure) | Clinically relevant changes in resting blood pressure (mmHq) | Baseline to Day 10 | 
| Number of subjects with clinically relevant changes in vital signs (pulse) | Clinically relevant changes in pulse (beats per minute) | Baseline to Day 10 | 
| Number of subjects with clinically relevant changes in vital signs (oral body temperature) | Clinically relevant changes in oral body temperature (fahrenheit/celsius) | Baseline to Day 10 | 
| Number of subjects with laboratory abnormalities in chemistry parameters | Clinically relevant abnormalities in any chemistry laboratory parameters tested (standard units): Sodium, potassium, creatinine, creatine phosphokinase, urea nitrogen, calcium , alkaline phosphatase , aspartate aminotransferase , alanine aminotransferase , gamma glutamyl transferase , bilirubin, lactate dehydrogenase, cholesterol, triglycerides, glucose (fasting), albumin, protein, or tryptase | Baseline to Day 10 | 
| Number of subjects with laboratory abnormalities in haematology parameters | Clinically relevant abnormalities in any haematology laboratory parameter tested (standard units): erythrocytes, hematocrit, hemoglobin, or white blood cells | Baseline to Day 10 | 
| Number of subjects with laboratory abnormalities in urinalysis parameters | Clinically relevant laboratory abnormalities in any urinalysis parameters (standard units): protein, glucose, ketones, occult blood, leukocytes, or nitrite | Baseline to Day 10 | 
| Number of subjects with abnormal ECGs | Abnormal ECGs (maximum QTcF interval of ≥450 msec, or maximum change from baseline of ≥60 msec) | Baseline to Day 10 | 
| AUC (0 to last) | Area under the plasma concentration time curve (AUC) from time 0 extrapolated to infinity (AUC0 inf) | pre-dose to 48 hours of each treatment period (Day 1 and Day 8) | 
| tmax | Time to maximum plasma concentration | pre-dose to 48 hours of each treatment period (Day 1 and Day 8) | 
| t 1/2 | Terminal elimination half life | pre-dose to 48 hours of each treatment period (Day 1 and Day 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy