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

Inclusion Criteria:

1. Subjects who are willing and are able to provide a written informed consent to
participate in the study

2. Adult male and female subjects aged between 18 and 60 (both inclusive) years old

3. Subjects with a BMI between 19 to 40 kg/m2

4. Subjects, who are healthy, as having no clinically significant abnormalities in
medical history, physical examination, clinical laboratory test results (hematology,
biochemistry and urinalysis), vital signs and 12-lead electrocardiogram (ECG). The
clinical significance of any abnormal finding in these parameters is left to the
judgment of the Investigator, in conjunction with the Sponsor's clinical leader prior
to enrolment

5. Subjects who smoke less than 10 cigarettes per day and are able to refrain from
smoking during confinement

6. Subjects with the ability and willingness to abstain from alcohol,
methylxanthine-containing beverages or food (coffee, tea, coke, chocolate, "power
drinks") and grapefruit juice starting from 72 hrs prior to the first admission
(confinement) and continuing throughout the study

7. Subjects who have a high probability for compliance with the study procedures
including ability and willingness to swallow capsules during the study and allow
withdrawing blood samples

8. Male subjects who are agreeable to use methods of contraception as specified in the
protocol during the study and up to 30 days after the administration of the last dose
of the study drug

9. Female subjects who are of non-child bearing potential defined as females who are
either post menopausal [i.e. 1 year of natural (spontaneous) amenorrhea or
break-through bleeding together with follicle stimulating hormone (FSH) confirmation
of post-menopausal state at screening)] or surgically sterilized [hysterectomy, tubal
occlusion, bilateral oophorectomy or bilateral salpingectomy]. FSH is required to
document post-menopausal status in women <55 years of age or in women >55 with < 2
years since last menstrual period. FSH is not required for women >55 with >2 years
since last menstrual period.

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.