Study to Determine the Safety, Tolerability, Pharmacokinetics, Food Effect and Pharmacodynamics of Single and Multiple Ascending Doses of P7435 in Healthy, Overweight or Obese Subjects

Exclusion Criteria

• •1. Employees of the Sponsor, Clinical Research Organization (CRO) or clinical sites
• •2. Subjects in an acute disease state within 7 days before Day -1 of the study
• •3. Subjects with past or current diseases of any organ or system (such as, but not limited to, gastrointestinal, cardiac, renal, hepatic that is considered to be clinically significant by the Investigator, in conjunction with the Sponsor's clinical leader or subjects suffering from any condition that can affect the absorption, distribution, metabolism and excretion of orally administered medicines. Subjects with conditions such as non malignant skin diseases and childhood asthma can be included based on the Investigator's discretion and discussed with the Sponsor a priori)
• •4. Subjects with known congenital QTc prolongation or having QTcF value of \>450 msec
• •5. Subjects with a history of sleep apnea, irregular sleep/wake cycle or working in night shifts
• •6. Subjects with a history of hypo/hyperthyroidism, (except those with thyroxin replacement and on stable dose since last 2 months) or repeated abnormal TSH values at screening or obesity of endocrine origin
• •7. Subjects with a history of anaphylaxis or angioedema, or other clinically important food or drug allergy
• •8. Subjects with known lactose intolerance and / or intolerance / allergy to any component of the diet, including milk, soy and the high fat breakfast proposed to be given during the study
• •9. Subjects with a history of mental handicap, psychiatric disorders including (but not limited to) eating disorders, seizures or significant head trauma
• •10. Subjects with a history of drug abuse, addiction or use of recreational drug
• •11. Subjects with a history of alcoholism for more than 2 years or consumption of more than 3 alcoholic drinks per day or consumption of alcohol within 48 hours prior to dosing and during the study (one drink is equal to one unit of alcohol - one glass wine, half pint beer, one measure or ounce of spirit)
• •12. Subjects with a history of fainting from blood collections or vasovagal syncope
• •13. Subjects with prior exposure to P7435 or participation in any of the previous cohorts
• •14. Subjects with a positive serology for human immunodeficiency virus (HIV-1/2) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies
• •15. Subjects with positive findings in urine drug screen
• •16. Subjects with a positive finding in urine alcohol screen
• •17. Subjects who have participated in another clinical trial within 30 days prior to the first drug administration
• •18. Subjects who are consuming any prescription drugs (including, but not limited to, sedatives and steroids); herbal supplements (including, but not limited to, St. John's Extract); or any other drugs likely to cause pharmacokinetic interaction within 30 days or 5 half lives, before first drug administration whichever is longer. Subjects using any other over-the-counter drugs (with the exception of paracetamol/NSAIDs and multivitamins that may be allowed up to 3 and 7 days before admission to the clinic, respectively) within 14 days or 5 half lives, prior to the first drug administration. Subjects who have undergone any weight loss surgery or are taking weight loss medications (including alternate medicine products) within 90 days prior to first drug administration
• •19. Subjects following an unusual diet e.g. low caloric, low sodium, within 30 days prior to first drug administration
• •20. Subjects who have donated blood (i.e. 350 mL) within 90 days prior to first drug administration.