Safety and Efficacy of Low Doses of V24343 in Obese Subjects

Inclusion criteria

Subjects must:

• be healthy male subjects aged 18 to 60 years
• have a body mass index greater than or equal to 27 kg/m2
• have a waist measurement >94 cm
• have blood pressure (BP) within the ranges systolic BP (SBP): 90-150 mmHg; diastolic BP (DBP): 40-90 mmHg, based on mean of day time readings recorded during a 24 hour period of ambulatory monitoring:
• be willing to use an effective method of contraception (condom with a spermicidal contraceptive, or sterilised) for the duration of the study and for 3 months after the last dose of study medication
• have an acceptable medical and social history in the 12 months prior to screening
• be able to comply with the requirements of the entire study
• give written informed consent

Exclusion criteria

Subjects must not:

• have received V24343 previously
• suffer from or have a history of anxiety or depression; have abnormal results on Patient Health Questionnaire 9 or Profile of Mood States (see Section 6.3.4.5)
• have a history of seizures (excluding febrile convulsions below 3 years of age)
• be male subjects whose female partners are trying to become pregnant within 3 months after the last dose of study medication
• have a significant medical condition or a history of such a condition that the Investigator considers should exclude the subject from the study
• have multiple drug allergies or be allergic to any of the components of V24343 study medication
• be smokers whom smoke more than 10 cigarettes per day
• consume more than 28 units of alcohol per week, or have a significant history of alcohol abuse
• have a positive test for alcohol or drugs of abuse at screening or admission to any of the treatment periods
• have donated blood or plasma in excess of 500 mL within 3 months of screening
• have been exposed to any new investigational agent within 3 months prior to study drug administration
• have clinically significant abnormalities on laboratory screening tests, particularly liver function and renal function tests (see Section 6.3.4.2)
• have clinically relevant abnormal physical findings on examination
• have clinically relevant abnormal findings on 12-lead ECG including a mean QTcB at screening ≥430 msec
• be seropositive for hepatitis B, hepatitis C or human immunodeficiency (HIV) viruses at screening
• have any medical or social reasons for not participating in the study raised by their General Practitioner/primary care physician
• have any other condition that might increase the risk to the individual or decrease the chance of obtaining satisfactory data, as assessed by the Investigator
• have had treatment with any prescription medicine within one month of first dose or any over-the-counter medicines, except for paracetamol, within one week of the first dose