A Trial to Evaluate the Effect of Food on LEO 152020

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

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

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.

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.