HealthyPhase 1NCT04203836
A Trial to Evaluate the Effect of Food on LEO 152020
A Phase 1 study testing LEO 152020 Tablet in people with Healthy, run by JW Pharmaceutical at 2 sites in 2 countries.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LEO 152020 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Jan 2020to 12 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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
Read the 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.
- Conditions
- Healthy
- Being tested
- LEO 152020 Tablet
- Keywords
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 152020 TabletDrug
film-coated tablet
| Study group | Role | What they receive |
|---|---|---|
| Fed | Experimental | Single oral dose given after a full breakfast Receives: Drug: LEO 152020 Tablet |
| Fasting | Experimental | Single oral dose given in fasting state Receives: Drug: LEO 152020 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed plasma concentration
Measured: 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)
Measured: 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
Number of AEs per subject at each combination of treatment and in total
Measured: 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)
Measured: Baseline to Day 10
Number of subjects with clinically relevant changes in vital signs (pulse)
Clinically relevant changes in pulse (beats per minute)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Baseline to Day 10
AUC (0 to last)
Area under the plasma concentration time curve (AUC) from time 0 extrapolated to infinity (AUC0 inf)
Measured: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
tmax
Time to maximum plasma concentration
Measured: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
t 1/2
Terminal elimination half life
Measured: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start9 Jan 2020
- Primary completion12 Dec 2020
- Study completion12 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Single dose, cross-over with food effect
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LEO Pharma
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203836
- Sponsor's protocol ID
- LP0190-1487
- Status last verified
- Apr 2024
- First submitted
- 17 Dec 2019
- Last updated
- 22 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomised, Oral Dose Trial to Evaluate the Effect of Food on LEO 152020 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04203836
- Acronym / sponsor ID
- LP0190-1487
- Conditions
- Healthy
- Keywords
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- LEO Pharma
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 12 Dec 2020 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Single dose, cross-over with food effect
| Arm | Type | Receives |
|---|---|---|
| Fed | Experimental | Drug: LEO 152020 TabletSingle oral dose given after a full breakfast |
| Fasting | Experimental | Drug: LEO 152020 TabletSingle oral dose given in fasting state |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEO 152020 Tabletfilm-coated tablet | Drug | Fasting, Fed |
Primary outcome
Cmax
Time frame: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
Maximum observed plasma concentration
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)
11 secondary outcomes
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 subjects with clinically relevant changes in vital signs (resting blood pressure)
Time frame: Baseline to Day 10
Number of subjects with clinically relevant changes in vital signs (pulse)
Time frame: Baseline to Day 10
Number of subjects with clinically relevant changes in vital signs (oral body temperature)
Time frame: Baseline to Day 10
Number of subjects with laboratory abnormalities in chemistry parameters
Time frame: Baseline to Day 10
Number of subjects with laboratory abnormalities in haematology parameters
Time frame: Baseline to Day 10
Number of subjects with laboratory abnormalities in urinalysis parameters
Time frame: Baseline to Day 10
Number of subjects with abnormal ECGs
Time frame: Baseline to Day 10
AUC (0 to last)
Time frame: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
tmax
Time frame: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
t 1/2
Time frame: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: Yes. De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Expert study director
LEO Pharma
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LEO 152020 Tablet in people with Healthy, run by JW Pharmaceutical at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.