Clinical trial NCT04203836: A Trial to Evaluate the Effect of Food on LEO 152020
Official title: A Phase 1, Randomised, Oral Dose Trial to Evaluate the Effect of Food on LEO 152020 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: LEO Pharma
First posted: 2019-12-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Single dose, cross-over with food effect
Primary purpose: BASIC_SCIENCE

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cmax
timeFrame: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
measure: AUC (0 to infinity)
timeFrame: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
Secondary outcomes:
measure: Number of total adverse events (AEs) and number of subjects with AEs at each combination of treatment and period
timeFrame: Baseline to Day 10
measure: Number of subjects with clinically relevant changes in vital signs (resting blood pressure)
timeFrame: Baseline to Day 10
measure: Number of subjects with clinically relevant changes in vital signs (pulse)
timeFrame: Baseline to Day 10
measure: Number of subjects with clinically relevant changes in vital signs (oral body temperature)
timeFrame: Baseline to Day 10
measure: Number of subjects with laboratory abnormalities in chemistry parameters
timeFrame: Baseline to Day 10
measure: Number of subjects with laboratory abnormalities in haematology parameters
timeFrame: Baseline to Day 10
measure: Number of subjects with laboratory abnormalities in urinalysis parameters
timeFrame: Baseline to Day 10
measure: Number of subjects with abnormal ECGs
timeFrame: Baseline to Day 10
measure: AUC (0 to last)
timeFrame: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
measure: tmax
timeFrame: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
measure: t 1/2
timeFrame: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Leo Investigational Site
state: Texas
city: Leeds
country: United Kingdom
facility: LEO Pharma Investigational Site
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: