Status:
TERMINATED
Safety, Tolerability and Efficacy Study of PP1420 in HV
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Wellcome Trust
Imperial College Healthcare NHS Trust
Conditions:
Obesity
Eligibility:
MALE
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
Obesity is a growing pandemic which affects 1 in 4 adults in the UK, and shortens life by increasing cardiovascular disease, diabetes and cancer. Current treatments for obesity have either poor effica...
Detailed Description
More than 25% of people in the UK are obese. People with obesity have a shorter life expectancy, and have a higher risk of having heart attacks, strokes, high blood pressure, diabetes, and certain can...
Eligibility Criteria
Inclusion
- Healthy male as determined by a responsible physician, based on a medical evaluation including history, physical examination, vital signs, laboratory tests and 12-lead ECG.
- Between 18 and 50 years of age, inclusive, at the time of signing and dating the informed consent form.
- Body weight 70 kg and body mass index (BMI) within the range 25 - 35 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Willing and able to comply with the protocol for the duration of the study.
Exclusion
- As a result of the medical interview, physical examination, or screening investigations, the Investigator considers the subject unsuitable for the study.
- The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- A positive test for human immunodeficiency virus (HIV) antibody.
- History of migraine.
- History or evidence of abnormal eating behaviour, as observed through the Dutch Eating Behaviour (DEBQ) and SCOFF questionnaires.
- History of excessive alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units. One unit is equivalent to 8 g of alcohol, a half-pint (approximately 240 mL) of beer or 1 measure (25 mL) of spirits or 1 glass (125 mL) of wine.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Has QTc at screening \>450 msec.
- Systolic blood pressure outside the range 85 - 160 mmHg, diastolic blood pressure outside the range 45 - 100 mmHg, and/or heart rate outside the range 40 - 110 bpm.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the dosing day in the current study: 90 days, five half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 14 days or five half-lives (whichever is longer) prior to the dose of study medication, which, in the opinion of the Investigator, may interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator, contraindicates their participation.
- Where participation in the study would result in donation of blood in excess of 500 mL within 3 months before or after the study.
- Unwilling to abstain from:
- Consumption of caffeine- or xanthine- containing products for 24 hours prior to dosing until the post-dose assessment at each treatment level.
- Use of illicit drugs.
- Alcohol for 48 hours prior to dosing until final post-dose assessment at each treatment level.
- Smoking or otherwise consuming tobacco for 24 hours prior to dosing until the post-dose assessment at each treatment level.
- Unwilling or unable to use a condom during sexual activity from first dose until the end of the study.
- Vegans and subjects with milk or wheat intolerance or allergy as reported by the subject.
- Unwillingness or inability to follow the procedures outlined in the protocol.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT02221765
Start Date
August 1 2014
End Date
May 1 2016
Last Update
September 22 2021
Active Locations (1)
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1
NIHR/ Wellcome Trust Imperial Clinical Research Facility
London, United Kingdom, W120HS