Psoriasis VulgarisPhase 1NCT02753218
A Phase I Study With LEO 32731 and Midazolam in Healthy Male Subjects
A Phase 1 study testing Midazolam and LEO 32731 in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate the effects of multiple oral doses of LEO 32731 on the pharmacokinetics of a single oral dose of the cytochrome P450 3A substrate midazolam in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Midazolam and LEO 32731
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to May 2016
- 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 59 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- caucasian
- between 18 and 59 years of age, inclusive
- Subjects will have a body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
- Subjects must be of good health
Who cannot join
- Male subjects who are not willing, or whose partners are not willing, to use appropriate contraception (such as condom with spermicidal foam/gel/film/cream/suppository), or who are not willing to refrain from donating 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 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.
- Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration of midazolam.
- Subjects who have received any medications, including St John's Wort (or other dietary restriction), known to chronically alter drug absorption or elimination processes (change enzyme levels) within 30 days of the first dose administration of midazolam.
- 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) or a marketed drug within the past 3 months prior to the first dosing occasion.
Show all 20Show fewer
- Subjects who have donated any blood, plasma or platelets in 3 months prior to screening or who have made donations on more than 2 occasions within the 12 months preceding the first dose administration of midazolam.
- Subjects with a significant history of drug allergy as determined by the Investigator.
- Subjects who have any clinically significant allergic disease (excluding non-active hayfever) as determined by the Investigator.
- 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 45 bpm, respectively.
- Subjects who consume more than 28 units of alcohol per week.
- Subjects who have a significant history of alcoholism or drug/chemical abuse as determined by the Investigator.
- Subjects with a positive urine drugs of abuse screen or alcohol breath test result at screening or first admission.
- Subjects who smoke or who have smoked in the 3 months prior to first dose administration.
- Subjects with, or with a history of, any clinically significant neurological, gastrointestinal (GI), renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, dermatological or other major disorders as determined by the Investigator.
- Subjects who have had a clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator.
- 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 human immunodeficiency virus (HIV) antibodies.
- Active tuberculosis or history of incompletely treated tuberculosis, based on medical history or medical report, or tuberculosis test at screening.
- Subjects who, in the opinion of their General Practitioner or the Investigator, should not participate in the study, including subjects suspected for whatever reason of not being able to comply with the requirements of the protocol.
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Covance Clinical Research Unit Ltd., Springfield House, Hyde Street
Leeds, LS2 9LH
About this study
Official title: LEO 32731 - A Phase I Drug-Drug Interaction Study With LEO 32731 and Midazolam in Healthy Male Subjects
The purpose of this study is to investigate the effects of multiple oral doses of LEO 32731 on the pharmacokinetics of a single oral dose of the cytochrome P450 3A substrate midazolam in healthy male subjects.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Midazolam, LEO 32731
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
LEO 32731Drug
| Study group | Role | What they receive |
|---|---|---|
| Midazolam and LEO 32731 | Experimental | Not described Receives: Drug: Midazolam; Drug: LEO 32731 |
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) of midazolam on Day 17
Measured: 17 days
Peak Plasma Concentration (Cmax) of midazolam on Day 17
Measured: 17 days
Secondary outcomes (3)
AUC of midazolam on Day 1
Measured: 1 day
Cmax of midazolam on Day 1
Measured: 1 day
Incidence and severity of adverse events (AEs) defined as spontaneously reported AEs and clinically significant values reported as AEs
Assessments for: blood pressure, pulse, temperature, pulse oximetry, 12-lead electrocardiograms (ECGs), physical examinations, and laboratory evaluations
Measured: 54 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Due to tolerability issues related to the dose titration, unexpected withdrawals were observed and it was unlikely for the trial to meet its objectives
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT02753218
- Sponsor's protocol ID
- LP0058-1267
- Status last verified
- May 2017
- First submitted
- 12 Apr 2016
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- 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 Drug-Drug Interaction Study With LEO 32731 and Midazolam in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02753218
- Acronym / sponsor ID
- LP0058-1267
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to tolerability issues related to the dose titration, unexpected withdrawals were observed and it was unlikely for the trial to meet its objectives
- Enrolment
- 12 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 Apr 2016 (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.
The purpose of this study is to investigate the effects of multiple oral doses of LEO 32731 on the pharmacokinetics of a single oral dose of the cytochrome P450 3A substrate midazolam in healthy male subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Midazolam and LEO 32731 | Experimental | Drug: Midazolam, Drug: LEO 32731 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
- caucasian
- between 18 and 59 years of age, inclusive
- Subjects will have a body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
- Subjects must be of good health
Key exclusion criteria (20 listed)
- Male subjects who are not willing, or whose partners are not willing, to use appropriate contraception (such as condom with spermicidal foam/gel/film/cream/suppository), or who are not willing to refrain from donating 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 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.
- Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration of midazolam.
- Subjects who have received any medications, including St John's Wort (or other dietary restriction), known to chronically alter drug absorption or elimination processes (change enzyme levels) within 30 days of the first dose administration of midazolam.
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 |
|---|---|---|
| Midazolam | Drug | Midazolam and LEO 32731 |
| LEO 32731 | Drug | Midazolam and LEO 32731 |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of midazolam on Day 17
Time frame: 17 days
Peak Plasma Concentration (Cmax) of midazolam on Day 17
Time frame: 17 days
3 secondary outcomes
AUC of midazolam on Day 1
Time frame: 1 day
Cmax of midazolam on Day 1
Time frame: 1 day
Incidence and severity of adverse events (AEs) defined as spontaneously reported AEs and clinically significant values reported as AEs
Time frame: 54 days
Results and safety
The study was stopped early (reason given: Due to tolerability issues related to the dose titration, unexpected withdrawals were observed and it was unlikely for the trial to meet its objectives). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
Related trials for Psoriasis Vulgaris
Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
Psoriasis Vulgaris, Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris
Not yet recruiting
Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
Psoriasis, Psoriasis; Plaque
RecruitingPhase 1
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of HRS-4139 in Healthy Participants
Psoriasis Vulgaris
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 Midazolam and 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 20 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: stopped early, 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. 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 was stopped early (reason given: Due to tolerability issues related to the dose titration, unexpected withdrawals were observed and it was unlikely for the trial to meet its objectives). Results are not available in the source record.
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) of midazolam on Day 17 (time frame: 17 days). 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 3 May 2017.