Healthy
Conditions
Keywords
Healthy
Brief summary
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
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.
Interventions
film-coated tablet
Sponsors
LEO Pharma
JW Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Single dose, cross-over with food effect
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | pre-dose to 48 hours of each treatment period (Day 1 and Day 8) | Maximum observed plasma concentration |
| AUC (0 to infinity) | pre-dose to 48 hours of each treatment period (Day 1 and Day 8) | Area under the plasma concentration time curve (AUC) from time 0 extrapolated to infinity (AUC0 inf) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with clinically relevant changes in vital signs (pulse) | Baseline to Day 10 | Clinically relevant changes in pulse (beats per minute) |
| Number of subjects with clinically relevant changes in vital signs (oral body temperature) | Baseline to Day 10 | Clinically relevant changes in oral body temperature (fahrenheit/celsius) |
| Number of subjects with laboratory abnormalities in chemistry parameters | Baseline to Day 10 | 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 |
| Number of subjects with laboratory abnormalities in haematology parameters | Baseline to Day 10 | Clinically relevant abnormalities in any haematology laboratory parameter tested (standard units): erythrocytes, hematocrit, hemoglobin, or white blood cells |
| Number of total adverse events (AEs) and number of subjects with AEs at each combination of treatment and period | Baseline to Day 10 | Number of AEs per subject at each combination of treatment and in total |
| Number of subjects with abnormal ECGs | Baseline to Day 10 | Abnormal ECGs (maximum QTcF interval of ≥450 msec, or maximum change from baseline of ≥60 msec) |
| AUC (0 to last) | pre-dose to 48 hours of each treatment period (Day 1 and Day 8) | Area under the plasma concentration time curve (AUC) from time 0 extrapolated to infinity (AUC0 inf) |
| tmax | pre-dose to 48 hours of each treatment period (Day 1 and Day 8) | Time to maximum plasma concentration |
| t 1/2 | pre-dose to 48 hours of each treatment period (Day 1 and Day 8) | Terminal elimination half life |
| Number of subjects with laboratory abnormalities in urinalysis parameters | Baseline to Day 10 | Clinically relevant laboratory abnormalities in any urinalysis parameters (standard units): protein, glucose, ketones, occult blood, leukocytes, or nitrite |
| Number of subjects with clinically relevant changes in vital signs (resting blood pressure) | Baseline to Day 10 | Clinically relevant changes in resting blood pressure (mmHq) |
Countries
United Kingdom, United States
Outcome results
None listed