Safety and Efficacy of Low Doses of V24343 in Obese Subjects

NCT00734201 | Completed Phase 1

• 1 other identifier: V24343-1Ob-03
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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, change in blood pressure (BP) and pulse, will be assessed both by outpatient ambulatory monitoring of vital signs and by regular clinic monitoring. The efficacy of V24343 will be assessed by measurement of body weight, waist circumference, bioimpedance assessment of body composition and blood glucose. Assay of plasma concentration of V24343 in blood samples collected at intervals after dosing will be used to assess the pharmacokinetics of V24343. Other safety assessments comprise routine monitoring of adverse events; concomitant medication; clinical laboratory safety tests, 12-lead electrocardiograms (ECG) and self-completed psychiatric assessments.

Conditions

Obesity

Keywords

Study effects on blood pressure and weight in obese subjects

Outcome Measures

Primary Outcomes (1)

• To examine any effects of V24343 on pulse and blood pressure (vital signs)

  24-hour on screening and pre-dose on Days 2, 26 and 56. Semi -recumbent and stand SBP , DBP and pulse, in duplicate at each time point.

Secondary Outcomes (1)

• To determine if there is adequate differentiation between doses of V24343 associated with any effect on vital signs and those associated with efficacy (weight loss).

  Body weight and wasit circumference: screen and time-matched to pre-dose on Days -1, 8, 15, 22, 29, 35, 42, 49 and 56.

Study Arms (1)

1

EXPERIMENTAL

Randomised to a parallel group comparison of either one of four doses of study drug (1mg, 2mg, 5mg, 25mg) or placebo. Dosed once daily for 28 days

Drug: V24343

Interventions

V24343 DRUG

Oral, 1mg, 2 mg, 5 mg or 25 mg, or placebo, once daily for 28 days

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vernalis (R&D) Ltd: lead

Study Sites (1)

Hammersmith Medicines Research

London, NW10 7NS, United Kingdom

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Steve Warrington

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 14, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: July 25, 2011

Record last verified: 2011-07

Locations

GB (1)