Clinical trial NCT01007383: LEO 27847 - A Study in Healthy Male Subjects
Official title: LEO 27847 - A Phase 1, Double-Blind, Placebo Controlled, Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety and tolerability of LEO 27847
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2009-11-04
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this first-in-man trial is to determine the safety and tolerability of ascending single and multiple doses of LEO 27847 in healthy male subjects. The trial will be performed in two parts. In Part 1, single doses of LEO 27847 will be administered to healthy male subjects. In Part 2, multiple doses of LEO 27847 will be administered to healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects will be male 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)
* Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions

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 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 50 bpm, respectively. Healthy young males with a pulse rate of between 45 and 50 bpm may be included at the discretion of the investigator.
* Subjects who consume more than 28 units (males) 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 more than 15 cigarettes or the equivalent in tobacco per day
* 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 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

Primary outcomes:
measure: Adverse events
timeFrame: 7 days after last dosing
Secondary outcomes:
measure: LEO 27847 in blood and urine
timeFrame: 72 hours after dosing
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit Ltd.
Study officials:
affiliation: Covance
name: Joseph Chiesa, MD
role: PRINCIPAL_INVESTIGATOR
References: