Psoriasis VulgarisPhase 1NCT03231124
Multiple Dose Study With Incremental Dosing to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Doses of LEO 32731 in Healthy Male Japanese Subjects.
A Phase 1 study testing LEO 32731 in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in United Kingdom.
Trial summary
This trial will investigate the safety, tolerability and pharmacokinetic (PK) data of LEO 32731 (and major human metabolite LEO 40815) in healthy male Japanese subjects. The primary objective is the assessment of PK in Japanese subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- LEO 32731
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jul 2017to 22 Aug 2017
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH Good Clinical Practice (GCP) Guideline E6 (1996) and applicable regulations, before completing any study-related procedures.
- An understanding, willingness and ability to fully comply with study procedures and restrictions.
- Japanese men aged >20 to <45 years (from date of signing informed consent which is defined as the beginning of the Screening Period). This inclusion criterion will only be assessed at the Screening Visit.
- Japanese subjects must have lived outside of Japan for ≤ 5 years in total and be first generation Japanese, defined as born in Japan and having 4 biologic grandparents who are ethnic Japanese.
- Subjects must have a body mass index (BMI) between 18.0-25.0 kg/m².
Who cannot join
- Current or recurrent disease (i.e. with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, dermatological or other major disorders as determined by the Investigator) that could affect the action, absorption, or disposition of LEO 32731, or could affect clinical assessments or clinical laboratory evaluations.
- Current or relevant history of physical or psychiatric illness that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
- Any history of psychiatric or mental health issue such (including depression) deemed clinically significant as assessed by the Investigator.
- Any history of/or active cancer or malignancy (other than squamous cell carcinoma more than 5 years prior).
- History of Wiskott-Aldrich Syndrome
- History of active tuberculosis, and/or history of partially or incomplete treatment of tuberculosis.
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- Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, may influence the result of the study, or the subject's ability to participate in the study.
- Use of any prescribed systemic or topical medication(s) within 14 days or 10 half-lives (whichever is longer) prior to Day 1 of the dosing period.
- Use of any systemic or topical non-prescribed or over-the-counter (OTC) medication(s) (including multivitamin, herbal, or homeopathic preparations) within 7 days or 5 half-lives (whichever is longer) prior to Day 1 of the dosing period. The occasional use of paracetamol (acetaminophen) is allowed to treat short term adverse events; subject to review by the investigator. The maximum allowed daily dose is 2000 mg for paracetamol at the discretion of the investigator.
- Consumption of more than 21 units of alcohol per week.
- History or clinical evidence of substance and/or alcohol abuse within the 12 months before screening. Alcohol abuse is defined as regular weekly intake of more than 21 units for males.
- Positive test results for alcohol, drugs of abuse at screening or Day -1.
- Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products in any form (e.g., gum, patch) within 90 days prior to Day 1 of the dosing period.
- Use of an investigational product within 90 days prior to Day 1 of the dosing period or active enrolment in another drug or vaccine clinical study.
- Known or suspected intolerance, hypersensitivity or allergy (excluding non-active hayfever) to any drug, food or other known substance (including investigational product, its closely related compounds, and/or any of the stated ingredients).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single Centre Randomised, Double-blind Placebo-controlled Multiple Dose Study With Incremental Dosing to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Doses of LEO 32731 in Healthy Male Japanese Subjects.
This trial will investigate the safety, tolerability and pharmacokinetic (PK) data of LEO 32731 (and major human metabolite LEO 40815) in healthy male Japanese subjects. The primary objective is the assessment of PK in Japanese subjects.
Data obtained from this trial will be used to compare with existing data from the other Phase 1 trials. This comparison of safety and PK profiles between Japanese and Caucasian subjects will allow the inclusion of Japanese patients into Phase 2b studies.
- Conditions
- Psoriasis Vulgaris
- Being tested
- LEO 32731, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 32731Drug
LEO 32731 is being developed by LEO Pharma.
PlaceboDrug
Placebo contains the same excipients in the same concentration, only lacking LEO 32731
| Study group | Role | What they receive |
|---|---|---|
| LEO 32731 | Experimental | Incremental dosing of LEO 32731 progressing to a maximum of 30 mg.
* Days 1 - 3: 10 mg dose twice a day for three days
* Days 4 - 6: 20 mg dose twice a day for three days
* Days 7 - 11: 30 mg dose twice a day for five days
* Days 12: 30 mg dose once in the morning Receives: Drug: LEO 32731 |
| Placebo | Placebo comparator | Incremental dosing of placebo progressing to a maximum of 30 mg.
* Days 1 - 3: 10 mg dose twice a day for three days
* Days 4 - 6: 20 mg dose twice a day for three days
* Days 7 - 11: 30 mg dose twice a day for five days
* Days 12: 30 mg dose once in the morning Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from zero to 12 hour (AUC0-12) on day 12 of LEO 32731.
Measured: on Day 12
Time to reach maximum observed plasma concentration (tmax) on day 12 of LEO 32731.
Measured: on Day 12
Maximum observed plasma concentration (Cmax) on day 12 of LEO 32731.
Measured: on Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start25 Jul 2017
- Primary completion22 Aug 2017
- Study completion22 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrike Lorch, MD, Principal investigator, Richmond Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231124
- Sponsor's protocol ID
- LP0058-1362
- Other IDs
- 2017-000907-26, 2017
- Status last verified
- Jun 2021
- First submitted
- 25 Jul 2017
- Last updated
- 29 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Centre Randomised, Double-blind Placebo-controlled Multiple Dose Study With Incremental Dosing to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Doses of LEO 32731 in Healthy Male Japanese Subjects.
- ClinicalTrials.gov ID
- NCT03231124
- Acronym / sponsor ID
- LP0058-1362
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 22 Aug 2017 (actual)
- Study completion
- 22 Aug 2017 (actual)
- First posted
- 27 Jul 2017 (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.
This trial will investigate the safety, tolerability and pharmacokinetic (PK) data of LEO 32731 (and major human metabolite LEO 40815) in healthy male Japanese subjects. The primary objective is the assessment of PK in Japanese subjects.
Data obtained from this trial will be used to compare with existing data from the other Phase 1 trials. This comparison of safety and PK profiles between Japanese and Caucasian subjects will allow the inclusion of Japanese patients into Phase 2b studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEO 32731 | Experimental | Drug: LEO 32731Incremental dosing of LEO 32731 progressing to a maximum of 30 mg. * Days 1 - 3: 10 mg dose twice a day for three days * Days 4 - 6: 20 mg dose twice a day for three days * Days 7 - 11: 30 mg dose twice a day for five days * Days 12: 30 mg dose once in the morning |
| Placebo | Placebo comparator | Drug: PlaceboIncremental dosing of placebo progressing to a maximum of 30 mg. * Days 1 - 3: 10 mg dose twice a day for three days * Days 4 - 6: 20 mg dose twice a day for three days * Days 7 - 11: 30 mg dose twice a day for five days * Days 12: 30 mg dose once in the morning |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH Good Clinical Practice (GCP) Guideline E6 (1996) and applicable regulations, before completing any study-related procedures.
- An understanding, willingness and ability to fully comply with study procedures and restrictions.
- Japanese men aged >20 to <45 years (from date of signing informed consent which is defined as the beginning of the Screening Period). This inclusion criterion will only be assessed at the Screening Visit.
- Japanese subjects must have lived outside of Japan for ≤ 5 years in total and be first generation Japanese, defined as born in Japan and having 4 biologic grandparents who are ethnic Japanese.
- Subjects must have a body mass index (BMI) between 18.0-25.0 kg/m².
Key exclusion criteria (15 listed)
- Current or recurrent disease (i.e. with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, dermatological or other major disorders as determined by the Investigator) that could affect the action, absorption, or disposition of LEO 32731, or could affect clinical assessments or clinical laboratory evaluations.
- Current or relevant history of physical or psychiatric illness that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
- Any history of psychiatric or mental health issue such (including depression) deemed clinically significant as assessed by the Investigator.
- Any history of/or active cancer or malignancy (other than squamous cell carcinoma more than 5 years prior).
- History of Wiskott-Aldrich Syndrome
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 32731LEO 32731 is being developed by LEO Pharma. | Drug | LEO 32731 |
| PlaceboPlacebo contains the same excipients in the same concentration, only lacking LEO 32731 | Drug | Placebo |
Primary outcome
Area under the plasma concentration-time curve from zero to 12 hour (AUC0-12) on day 12 of LEO 32731.
Time frame: on Day 12
Time to reach maximum observed plasma concentration (tmax) on day 12 of LEO 32731.
Time frame: on Day 12
Maximum observed plasma concentration (Cmax) on day 12 of LEO 32731.
Time frame: on Day 12
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 29 Jun 2021.
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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.
Ulrike Lorch, MD principal investigator
Richmond Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LEO 32731 in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in United Kingdom.
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 5 inclusion and 15 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 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. Some participants in this study may receive a placebo. 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?
Area under the plasma concentration-time curve from zero to 12 hour (AUC0-12) on day 12 of LEO 32731. (time frame: on Day 12). The study lists 3 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 29 Jun 2021; AzTrials last refreshed its copy on 27 Oct 2026.