A Trial to Evaluate the Effect of Food on LEO 152020

JW Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: LEO 152020 Tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT04203836

LP0190-1487

Details and patient eligibility

About

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

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.