A Trial to Evaluate the Effect of Food on LEO 152020

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04203836
• Other study ID #: LP0190-1487
• Status: Completed
• Phase: Phase 1
• Start date: January 9, 2020
• Est. completion date: December 12, 2020

Study information

• Verified date: April 2024
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 12, 2020
• Est. primary completion date: December 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LEO 152020 Tablet
film-coated tablet

Locations

Country	Name	City	State
United Kingdom	LEO Pharma Investigational Site	Leeds
United States	Leo Investigational Site	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
JW Pharmaceutical	LEO Pharma

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum observed plasma concentration	pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
Primary	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	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
Secondary	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
Secondary	Number of subjects with clinically relevant changes in vital signs (pulse)	Clinically relevant changes in pulse (beats per minute)	Baseline to Day 10
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	tmax	Time to maximum plasma concentration	pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
Secondary	t 1/2	Terminal elimination half life	pre-dose to 48 hours of each treatment period (Day 1 and Day 8)