Status:
COMPLETED
Safety and Efficacy of Low Doses of V24343 in Obese Subjects
Lead Sponsor:
Vernalis (R&D) Ltd
Conditions:
Obesity
Eligibility:
MALE
18-60 years
Phase:
PHASE1
Brief Summary
Randomised, double-blind, parallel group comparison of four dose levels of V24343 and placebo to study the effect of V24343 on blood pressure and weight in obese subjects. The primary variables, chan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00734201
Start Date
October 1 2008
End Date
March 1 2009
Last Update
July 25 2011
Active Locations (1)
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1
Hammersmith Medicines Research
London, United Kingdom, NW10 7NS