A Trial to Evaluate the Effect of Food on LEO 152020

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-09

Study Completion Date

2020-12-12

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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Single dose, cross-over with food effect

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fed

Single oral dose given after a full breakfast

Group Type EXPERIMENTAL

LEO 152020 Tablet

Intervention Type DRUG

film-coated tablet

Fasting

Single oral dose given in fasting state

Group Type EXPERIMENTAL

LEO 152020 Tablet

Intervention Type DRUG

film-coated tablet

Interventions

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LEO 152020 Tablet

film-coated tablet

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes