A First-Time-in-Human Study to Assess the Safety and Tolerability of PP 1420 in Healthy Subjects

Inclusion Criteria

• 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 18 - 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 Criteria

• 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.
• Unwilling to abstain from use of illicit drugs.
• Unwilling to abstain from alcohol for 48 hours prior to dosing until final post-dose assessment at each treatment level.
• Unwilling to abstain from smoking or otherwise consuming tobacco for 24 hours prior to dosing until the post-dose assessment at each treatment level.
• Unwilling 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.