Psoriasis VulgarisPhase 1NCT02514694
LEO 32731 - A Phase I Study in Healthy Subjects
A Phase 1 study testing LEO32731 in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in United Kingdom.
Trial summary
LEO 32731 ("Study Drug") is an investigational drug which is being developed by LEO Pharma A/S ("the Sponsor") for treatment of psoriasis. The aim (s) of this Study are to determine: The safety and tolerability of the Study Drug and any side effects that might be associated with it The Study will also measure how much… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- LEO32731
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Dec 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Subjects will, prior to any study related activities, have given their written informed consent to participate in the study and to abide by the study restrictions.
- 2. Subjects will be males or females of non-childbearing potential between 18 and 55 years of age.
- 3. Subjects will have a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive.
- 4. For Group C, subjects will be women of non-childbearing potential.
- 5. Subjects must be in good health.
Who cannot join
- 1. Male subjects who are not willing, or whose partners are not willing, to use appropriate contraception.
- 2. Subjects who have received any prescribed systemic or topical medication within 14 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
- 3. Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
- 4. Subjects who have received any medications, including St John's Wort (or other dietary restriction, Section 6.2.3), known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
- 5. Subjects with a significant history of drug allergy as determined by the Investigator.
- 6. Subjects who have any clinically significant allergic disease (excluding non-active hayfever) as determined by the Investigator.
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- 7. Subjects who have a supine blood pressure and supine pulse rate at screening higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 50 bpm, respectively.
- 8. Subjects with a positive urine drug screen or alcohol breath test result at screening or first admission.
- 9. Subjects 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.
- 10. Subjects who have had a clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator.
- 11. Subjects who are known to have serum hepatitis, or who are carriers of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody, or who have a positive result to the test for HIV antibodies.
- 12. Active tuberculosis or history of incompletely treated tuberculosis, based on medical history or medical report.
- 13. Subjects who, in the opinion of their General Practitioner (GP) or the Investigator, should not participate in the study.
- 14. Subjects with one or more positive faecal occult blood test (immunochemical method) out of 2 assessments at the time between screening and Day-1 check-in.
- 15. Subjects with ≥ 3 bowel movements/day.
- 16. Subjects who have previously taken part in or withdrawn from this study.
- 17. Subjects who, in the opinion of the Investigator, should not participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LEO 32731 - A Phase I, Single-Blind, Placebo-Controlled, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
LEO 32731 ("Study Drug") is an investigational drug which is being developed by LEO Pharma A/S ("the Sponsor") for treatment of psoriasis. The aim (s) of this Study are to determine:
- The safety and tolerability of the Study Drug and any side effects that might be associated with it
- The Study will also measure how much of the Study Drug that gets into the blood and how long time it takes for the body to remove it.
- Conditions
- Psoriasis Vulgaris
- Being tested
- LEO32731, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO32731Drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| LEO 32731 | Active comparator | Active Receives: Drug: LEO32731 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety reported as number of Participants with Adverse Events
Measured: 16 days
Secondary outcomes (1)
Pharmacokinetics reported as area under the plasma concentration versus time curve (AUC)
Measured: 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2015
- Study completionDec 2015
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514694
- Sponsor's protocol ID
- LP0058-1114
- Status last verified
- May 2017
- First submitted
- 8 Jul 2015
- Last updated
- 3 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEO 32731 - A Phase I, Single-Blind, Placebo-Controlled, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02514694
- Acronym / sponsor ID
- LP0058-1114
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Aug 2015 (estimated)
- 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.
LEO 32731 ("Study Drug") is an investigational drug which is being developed by LEO Pharma A/S ("the Sponsor") for treatment of psoriasis. The aim (s) of this Study are to determine:
- The safety and tolerability of the Study Drug and any side effects that might be associated with it
- The Study will also measure how much of the Study Drug that gets into the blood and how long time it takes for the body to remove it.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEO 32731 | Active comparator | Drug: LEO32731Active |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Subjects will, prior to any study related activities, have given their written informed consent to participate in the study and to abide by the study restrictions.
- 2. Subjects will be males or females of non-childbearing potential between 18 and 55 years of age.
- 3. Subjects will have a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive.
- 4. For Group C, subjects will be women of non-childbearing potential.
- 5. Subjects must be in good health.
Key exclusion criteria (17 listed)
- 1. Male subjects who are not willing, or whose partners are not willing, to use appropriate contraception.
- 2. Subjects who have received any prescribed systemic or topical medication within 14 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
- 3. Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
- 4. Subjects who have received any medications, including St John's Wort (or other dietary restriction, Section 6.2.3), known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
- 5. Subjects with a significant history of drug allergy as determined by the Investigator.
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 |
|---|---|---|
| LEO32731 | Drug | LEO 32731 |
| Placebo | Other | Placebo |
Primary outcome
Safety reported as number of Participants with Adverse Events
Time frame: 16 days
1 secondary outcome
Pharmacokinetics reported as area under the plasma concentration versus time curve (AUC)
Time frame: 16 days
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 3 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 LEO32731 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 17 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 3 May 2017. 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?
Safety reported as number of Participants with Adverse Events (time frame: 16 days). 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 3 May 2017.