HealthyPhase 1NCT01211964

LEO 22811 - Single Dose Bioavailability Study of Tablet Versus Oral Solution in Healthy Subjects

A Phase 1 study testing LEO 22811 in people with Healthy, run by LEO Pharma at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this phase 1 study is to determine the relative bioavailability and pharmacokinetics following single oral dose administration of LEO 22811 solution compared to LEO 22811 tablet in healthy male subjects as well as to determine the effect of food on the single oral dose pharmacokinetics of LEO 22811… 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: Healthy
What is being tested?: LEO 22811
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited Kingdom
Study dates: Sep 2010to Dec 2010
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 prior to any study related activities, have given their written informed consent to participate in the study and to abide by the study restrictions
Subjects will be Caucasian males between 18 and 55 years of age, with body mass index (BMI) between 18 and 32 kg/m2 both inclusive.
Subjects will have a minimum weight of 50 kg
Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations(congenital non-haemolytic hyperbilirubinaemia is acceptable)

Who cannot join

Male subjects who are not willing to use appropriate contraception (such as condom)and for female partners; occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository) from the time of the first dose until 3 months after the final dosing occasion
Subjects who have confirmed active/latent tuberculosis (TB)
Subjects with an infectious illness within 3 days prior to dosing
Subjects who have received any prescribed systemic or topical medication (including natural/herbal medicines) 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(with the exception of low to moderate use of vitamin/mineral supplements, however extreme vitamin use should be excluded) unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety
Subjects who have received any medications, including St John's Wort, 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

Show all 19Show fewer

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.
Subjects who have donated any blood, plasma or platelets in the month prior to screening or who have made donations on more than two occasions within the 12 months preceding the first dose administration
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 90/40 mmHg and 45 bpm, respectively, confirmed by repeat
Subjects who consume more than 28 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse as determined by the Investigator (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or 1/6 gill [25 mL] of spirits)
Subjects who smoke, or who have smoked within 3 months prior to first dose administration
Subjects with, or with a history of, any clinically significant neurological, gastrointestinal,renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine,haematological, dermatological, autoimmunological or other major disorders as determined by the Investigator
Subjects with a significant cardiac history (e.g. heart failure, hypokalemia, long QT syndrome) 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 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
Subjects who, in the opinion of their General Practitioner (GP) 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
Subject with serum levels of calcium, magnesium or potassium significantly outside the reference ranges. For subjects whose serum levels are not significantly outside these ranges, the physician may consult the sponsor with regards to approval for enrolment.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Covance Clinical Research Unit Ltd.
Leeds

Other trials in United Kingdom

About this study

Official title: LEO 22811 - A Single Dose Bioavailability Study of Oral Solid Dosage Form Versus Oral Solution Including Fed Versus Fasted State in Healthy Male Subjects

Conditions: Healthy
Being tested: LEO 22811

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LEO 22811Drug
Oral administration of solution and tablet.

Study groups in NCT01211964
Study group	Role	What they receive
LEO 22811 oral solution 1.5 mg (fasted state)	Experimental	Not described Receives: Drug: LEO 22811
LEO 22811 single tablet 1.5 mg (fasted state)	Experimental	Not described Receives: Drug: LEO 22811
LEO 22811 single tablet 1.5 (fed state)	Experimental	Not described Receives: Drug: LEO 22811

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC
Measured: 11 weeks
Tmax
Measured: 11 weeks
Cmax
Measured: 11 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Dec 2010

First posted30 Sep 2010 (estimated)
Study startSep 2010
Primary completionDec 2010
Study completionDec 2010

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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01211964
Sponsor's protocol ID: LEO 22811-S01
Other IDs: 2010-018388-41
Status last verified: Nov 2013
First submitted: 23 Sep 2010
Last updated: 24 Feb 2025
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: LEO 22811 - A Single Dose Bioavailability Study of Oral Solid Dosage Form Versus Oral Solution Including Fed Versus Fasted State in Healthy Male Subjects
ClinicalTrials.gov ID: NCT01211964
Acronym / sponsor ID: LEO 22811-S01
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 30 Sep 2010 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
LEO 22811 oral solution 1.5 mg (fasted state)	Experimental	Drug: LEO 22811
LEO 22811 single tablet 1.5 mg (fasted state)	Experimental	Drug: LEO 22811
LEO 22811 single tablet 1.5 (fed state)	Experimental	Drug: LEO 22811

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 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
Subjects will be Caucasian males between 18 and 55 years of age, with body mass index (BMI) between 18 and 32 kg/m2 both inclusive.
Subjects will have a minimum weight of 50 kg
Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations(congenital non-haemolytic hyperbilirubinaemia is acceptable)

Key exclusion criteria (19 listed)

Male subjects who are not willing to use appropriate contraception (such as condom)and for female partners; occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository) from the time of the first dose until 3 months after the final dosing occasion
Subjects who have confirmed active/latent tuberculosis (TB)
Subjects with an infectious illness within 3 days prior to dosing
Subjects who have received any prescribed systemic or topical medication (including natural/herbal medicines) 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(with the exception of low to moderate use of vitamin/mineral supplements, however extreme vitamin use should be excluded) unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety

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 22811Oral administration of solution and tablet.	Drug	LEO 22811 oral solution 1.5 mg (fasted state), LEO 22811 single tablet 1.5 (fed state), LEO 22811 single tablet 1.5 mg (fasted state)

Primary outcome

AUC
Time frame: 11 weeks
Tmax
Time frame: 11 weeks
Cmax
Time frame: 11 weeks

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 24 Feb 2025.
Individual participant dataSharing planned: No

Related trials for Healthy

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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

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 22811 in people with Healthy, 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 19 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 24 Feb 2025. 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?

AUC (time frame: 11 weeks). 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?

On the ClinicalTrials.gov record for NCT01211964.

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 24 Feb 2025.