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Completed

NCT Number: NCT04203836

A Trial to Evaluate the Effect of Food on LEO 152020

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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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

LEO Pharma Investigational Site, Leeds, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LEO 152020 tablet

Drug

film-coated tablet

Primary outcomes

  1. Cmax

    Time frame: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)

    Maximum observed plasma concentration

  2. AUC (0 to infinity)

    Time frame: 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 outcomes

  1. Number of total adverse events (AEs) and number of subjects with AEs at each combination of treatment and period

    Time frame: Baseline to Day 10

    Number of AEs per subject at each combination of treatment and in total

  2. Number of subjects with clinically relevant changes in vital signs (resting blood pressure)

    Time frame: Baseline to Day 10

    Clinically relevant changes in resting blood pressure (mmHq)

  3. Number of subjects with clinically relevant changes in vital signs (pulse)

    Time frame: Baseline to Day 10

    Clinically relevant changes in pulse (beats per minute)

  4. Number of subjects with clinically relevant changes in vital signs (oral body temperature)

    Time frame: Baseline to Day 10

    Clinically relevant changes in oral body temperature (fahrenheit/celsius)

  5. Number of subjects with laboratory abnormalities in chemistry parameters

    Time frame: 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

  6. Number of subjects with laboratory abnormalities in haematology parameters

    Time frame: Baseline to Day 10

    Clinically relevant abnormalities in any haematology laboratory parameter tested (standard units): erythrocytes, hematocrit, hemoglobin, or white blood cells

  7. Number of subjects with laboratory abnormalities in urinalysis parameters

    Time frame: Baseline to Day 10

    Clinically relevant laboratory abnormalities in any urinalysis parameters (standard units): protein, glucose, ketones, occult blood, leukocytes, or nitrite

  8. Number of subjects with abnormal ECGs

    Time frame: Baseline to Day 10

    Abnormal ECGs (maximum QTcF interval of ≥450 msec, or maximum change from baseline of ≥60 msec)

  9. AUC (0 to last)

    Time frame: 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)

  10. tmax

    Time frame: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)

    Time to maximum plasma concentration

  11. t 1/2

    Time frame: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)

    Terminal elimination half life

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Collaborators

  • LEO Pharma

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 18, 2019
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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