Psoriasis VulgarisPhase 1NCT02126371
LP0058-1005 - A Open-Label, Four-Way Crossover and Food-Effect Study of LEO 32731 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"), with an aim to help people with skin conditions called psoriasis. The aim (s) of this Study are to determine: The effects of the Study Drug when given as different formulations intended for oral… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- LEO32731
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to Jan 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be males of any ethnic origin between 18 and 55 years of age
- Subjects will have a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive
- Subjects must be in good health, as determined by: a medical history, physical examination, vital sign assessment, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is NOT acceptable)
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
Who cannot join
- Male subjects who are not willing, or whose partners are not willing, to use appropriate contraception (such as a condom with spermicidal foam/gel/film/cream/suppository), or donate sperm from the time of the first dose until 3 months after the final dosing occasion. Male subjects whose partners are of child-bearing potential must also agree to use an additional highly effective method of contraception
- Subjects who have an abnormality in heart rate, blood pressure, temperature or respiration rate that, in the opinion of the investigator, increases the risk of participating in the study, in accordance with Covance current reference ranges at screening confirmed by a repeat assessment.
- Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, confirmed by a repeat ECG: such as QTcB interval >450 msec, 2nd or 3rd degree, Atrioventricular block, complete left bundle branch block, complete right bundle branch block, Wolff-Parkinson-White Syndrome, defined as PR<110 msec,
- 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. slow release medicinal formulations considered to still be active 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.
- Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to the first dosing occasion
- Subjects with a significant history of drug allergy as determined by the Investigator.
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- Subjects who have any clinically significant allergic disease (excluding non-active hayfever) as determined by the Investigator.
- Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorders as determined by the Investigator.
- Subjects who: are known to have serum hepatitis, are carriers of the hepatitis B surface antigen (HBsAg) are carriers of the hepatitis C antibody, have a positive result to the test for HIV antibodies, have a history of active tuberculosis or history of incompletely treated tuberculosis within the last 5 years, confirmed by their medical records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LP0058-1005 - A Phase I, Open-Label, Four-Way Crossover and Food-Effect Study of LEO 32731 in Healthy Subjects When Administered as an Immediate and Modified Release Formulation
LEO 32731 ("Study Drug") is an investigational drug which is being developed by LEO Pharma A/S ("the Sponsor"), with an aim to help people with skin conditions called psoriasis. The aim (s) of this Study are to determine:
- The effects of the Study Drug when given as different formulations intended for oral administration (tablets and capsules)
- The safety of the Study Drug and any side effects that might be associated with it
- The effect of food on the Study Drug
- The Study will also measure how much of the Study Drug gets into the blood stream and how long it takes the body to remove it and what affect the Study Drug has on the body.
- Conditions
- Psoriasis Vulgaris
- Being tested
- LEO32731
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO32731Drug
| Study group | Role | What they receive |
|---|---|---|
| Active | Other | LEO32731 Receives: Drug: LEO32731 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC)
Measured: one week
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2015
- Study completionJan 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashley Brooks, MD, Principal investigator, Covance CRU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126371
- Sponsor's protocol ID
- LP0058-1005
- Status last verified
- Jun 2016
- First submitted
- 7 Apr 2014
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LP0058-1005 - A Phase I, Open-Label, Four-Way Crossover and Food-Effect Study of LEO 32731 in Healthy Subjects When Administered as an Immediate and Modified Release Formulation
- ClinicalTrials.gov ID
- NCT02126371
- Acronym / sponsor ID
- LP0058-1005
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Apr 2014 (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"), with an aim to help people with skin conditions called psoriasis. The aim (s) of this Study are to determine:
- The effects of the Study Drug when given as different formulations intended for oral administration (tablets and capsules)
- The safety of the Study Drug and any side effects that might be associated with it
- The effect of food on the Study Drug
- The Study will also measure how much of the Study Drug gets into the blood stream and how long it takes the body to remove it and what affect the Study Drug has on the body.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Other | Drug: LEO32731LEO32731 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects will be males of any ethnic origin between 18 and 55 years of age
- Subjects will have a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive
- Subjects must be in good health, as determined by: a medical history, physical examination, vital sign assessment, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is NOT acceptable)
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
Key exclusion criteria (9 listed)
- Male subjects who are not willing, or whose partners are not willing, to use appropriate contraception (such as a condom with spermicidal foam/gel/film/cream/suppository), or donate sperm from the time of the first dose until 3 months after the final dosing occasion. Male subjects whose partners are of child-bearing potential must also agree to use an additional highly effective method of contraception
- Subjects who have an abnormality in heart rate, blood pressure, temperature or respiration rate that, in the opinion of the investigator, increases the risk of participating in the study, in accordance with Covance current reference ranges at screening confirmed by a repeat assessment.
- Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, confirmed by a repeat ECG: such as QTcB interval >450 msec, 2nd or 3rd degree, Atrioventricular block, complete left bundle branch block, complete right bundle branch block, Wolff-Parkinson-White Syndrome, defined as PR<110 msec,
- 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. slow release medicinal formulations considered to still be active 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.
- Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to the first dosing occasion
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 | Active |
Primary outcome
Area under the plasma concentration versus time curve (AUC)
Time frame: one week
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: one week
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 14 Jun 2016.
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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.
Ashley Brooks, MD principal investigator
Covance CRU
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 4 inclusion and 9 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 14 Jun 2016. 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. 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 versus time curve (AUC) (time frame: one week). 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 14 Jun 2016.