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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LEO 152020 Tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom
    • LEO Pharma Investigational Site
• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • LEO Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fed; Single oral dose given after a full breakfast	Drug: LEO 152020 Tablet; film-coated tablet
Experimental: Fasting; Single oral dose given in fasting state	Drug: LEO 152020 Tablet; film-coated tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum observed plasma concentration	pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
AUC (0 to infinity)	Area under the plasma concentration time curve (AUC) from time 0 extrapolated to infinity (AUC0 inf)	pre-dose to 48 hours of each treatment period (Day 1 and Day 8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of total adverse events (AEs) and number of subjects with AEs at each combination of treatment and period	Number of AEs per subject at each combination of treatment and in total	Baseline to Day 10
Number of subjects with clinically relevant changes in vital signs (resting blood pressure)	Clinically relevant changes in resting blood pressure (mmHq)	Baseline to Day 10
Number of subjects with clinically relevant changes in vital signs (pulse)	Clinically relevant changes in pulse (beats per minute)	Baseline to Day 10
Number of subjects with clinically relevant changes in vital signs (oral body temperature)	Clinically relevant changes in oral body temperature (fahrenheit/celsius)	Baseline to Day 10
Number of subjects with laboratory abnormalities in chemistry parameters	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	Baseline to Day 10
Number of subjects with laboratory abnormalities in haematology parameters	Clinically relevant abnormalities in any haematology laboratory parameter tested (standard units): erythrocytes, hematocrit, hemoglobin, or white blood cells	Baseline to Day 10
Number of subjects with laboratory abnormalities in urinalysis parameters	Clinically relevant laboratory abnormalities in any urinalysis parameters (standard units): protein, glucose, ketones, occult blood, leukocytes, or nitrite	Baseline to Day 10
Number of subjects with abnormal ECGs	Abnormal ECGs (maximum QTcF interval of ≥450 msec, or maximum change from baseline of ≥60 msec)	Baseline to Day 10
AUC (0 to last)	Area under the plasma concentration time curve (AUC) from time 0 extrapolated to infinity (AUC0 inf)	pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
tmax	Time to maximum plasma concentration	pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
t 1/2	Terminal elimination half life	pre-dose to 48 hours of each treatment period (Day 1 and Day 8)

Collaborators and Investigators

• Sponsor: JW Pharmaceutical
• Collaborators: LEO Pharma
• Investigators: Study Director: Medical Expert, LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Actual): December 12, 2020
• Study Completion (Actual): December 12, 2020

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Healthy
• Other Study ID Numbers: LP0190-1487

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
• IPD Sharing Time Frame: Data is available to request after approval of the studied indication.
• IPD Sharing Access Criteria: Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No