CClinicalTrials.gg
CompletedNCT01143298Updated Feb 24, 2025

LEO 27847 - Single Dose Bioavailability Study of Oral Solution Versus Tablet in Healthy Subjects

A Phase 1 interventional study of LEO 27847 oral solution in Healthy, sponsored by LEO Pharma. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-24.

Sponsored by LEO Pharma · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

The purpose of this phase 1 study is to determine the relative bioavailability following single oral dose administration of LEO 27847 solution compared to LEO 27847 tablets in healthy male subjects as well as to determine the effect of food on the single oral dose pharmacokinetics of LEO 27847 tablets in healthy male subjects.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

LEO Pharma is the lead sponsor of 221 studies on the registry; 5 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subjects will 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 45 years of age, with body mass index (BMI) between 18 and 32 kg/m2 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)

Exclusion criteria

Exclusion Criteria:

  • 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 received any prescribed systemic or topical medication 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
  • 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
  • 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
  • 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 hay fever) 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, 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
  • 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 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 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
  • 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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    LEO 27847 oral solution 0.1 mg

    LEO 27847 oral solution 0.1 mg

    Drug: LEO 27847 oral solution

  • Experimental
    LEO 27847 tablet 0.10 mg

    LEO 27847 tablet 0.10 mg

    Drug: LEO 27847 oral solution

  • Experimental
    LEO 27847 tablet 0.01 mg

    LEO 27847 tablet 0.01 mg

    Drug: LEO 27847 oral solution

Interventions

  • DrugLEO 27847 oral solution
06

What researchers measure

Primary outcomes

  1. PK parameters

    AUC and Cmax in each group

    Time frame: 7 weeks

07

Study locations

1 site
  • Covance Clinical Research Unit Ltd.
    Leeds, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01143298
Lead sponsor
LEO Pharma
Responsible party
Sponsor
First posted
Jun 14, 2010
Start date
Jun 2010
Primary completion
Aug 2010
Completion
Sep 2010
Last update
Feb 24, 2025

Study contacts

Ashley Brooks, MD
principal investigator · Covance

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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