A Trial to Evaluate the Effect of Food on LEO 152020

NCT04203836 | Completed Phase 1

• 1 other identifier: LP0190-1487
• Study Type: interventional
• Target: 12
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Healthy

Keywords

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

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

  Baseline to Day 10

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

  Baseline to Day 10

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

  Baseline to Day 10

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

  Baseline to Day 10

• Number of subjects with laboratory abnormalities in chemistry parameters

  Baseline to Day 10

Study Arms (2)

Fed

EXPERIMENTAL

Single oral dose given after a full breakfast

Drug: LEO 152020 Tablet

Fasting

EXPERIMENTAL

Single oral dose given in fasting state

Drug: LEO 152020 Tablet

Interventions

LEO 152020 Tablet DRUG

film-coated tablet

Fasting; Fed

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• JW Pharmaceutical: lead
• LEO Pharma: collaborator

Study Sites (2)

Leo Investigational Site

Dallas, Texas, 75247, United States

Location

LEO Pharma Investigational Site

Leeds, United Kingdom

Location

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single dose, cross-over with food effect

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 18, 2019
• Study Start: January 9, 2020
• Primary Completion: December 12, 2020
• Study Completion: December 12, 2020
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data is available to request after approval of the studied indication.
• Access Criteria: Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.

Locations

US (1); GB (1)