Determination of Safety,Tolerability,Pharmacokinetics,Food Effect& Pharmacodynamics of Single & Multiple Doses of P11187

- In Part I, the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of
single ascending doses of P11187 will be studied in healthy, overweight or obese, male
and females (of non-child bearing potential) subjects. There will be up to 6 cohorts of
8 subjects each. At each dose level, 6 subjects will receive a single dose of active
treatment, P11187 and 2 subjects will receive a single dose of matching placebo. It is
planned that up to 6 dose levels of P11187 may be evaluated after single dose
administration.

- In Part II, the safety, tolerability, PK and PD of multiple ascending doses of P11187
administered once daily for 14 consecutive days will be studied in overweight or obese,
male and female of non-child bearing potential subjects with type 2 diabetes mellitus.
Up to 3 dose levels of P11187 are planned to be evaluated in 3 cohorts of 12 subjects
each for 14 days.At each dose level, 9 subjects will receive the active drug, P11187
and 3 subjects will receive matching placebo, once daily for a period of 14 days.

- In Part III, the food effect evaluation of P11187 will be performed in a randomized,
open-label, cross-over, two-period study at a single dose level in a cohort of 12
healthy male subjects to be administered the drug under fasted and fed
conditions.Subjects will be administered a single dose of P11187 in Periods 1 and 2
under fasted and fed conditions as per the randomization schedule, with a wash-out
interval of 7-10 days between the two periods. Subjects who have received the study
drug, P11187 under fasted conditions in Period 1 will cross-over and receive the study
drug under fed conditions in Period 2 and vice versa.

Inclusion Criteria:

1. Subjects willing to give written informed consent to participate in the study

2. Male & female subjects aged between 18 &70 years (both inclusive) in Part I & II) &
between 18 &70 years (both inclusive) in Part III

3. Subjects with a body mass index (BMI) between 19 &42 kg/m2(Part I), 22 &42 kg/m2
(Part II) & 19 &27 kg/m2 (Part III)

4. Healthy subjects having no clinically significant abnormalities in medical history,
physical examination, clinical laboratory tests, vital signs & 12-lead
electrocardiograms (ECG)

5. Female subjects of non-child-bearing potential, post-menopausal or surgically
sterilized (Part I & II)

6. Male subjects agreed to use contraceptive methods as per protocol during &
approximately 30 days after the exit/completion of their participation in the study

7. Part II: Subjects with type 2 diabetes mellitus at least 6 mths prior to screening

8. Part II: Subjects on diet & exercise alone or on a stable dose of metformin for a
period of at least 2 mths before screening. Subjects who are washed off other
medications such as sulfonyureas /alpha-glucosidase inhibitors, at least 14 days
prior to dosing.

9. Part II-Subjects with HbA1c between 6 &11% at screening

10. Part II-Subjects with fasting plasma glucose of ≤ 14.42 mmol/L (~260 mg/dL) at
screening

11. Part II-Subjects with C-peptide value of > 0.266 nmol/L (0.8 ng/mL) at screening

Exclusion Criteria:

1. Subjects with history of (H/O) significant gastrointestinal, cardiac, renal or liver
impairment

2. Subjects with known congenital QTc prolongation or QTcF greater than 450 ms

3. Subjects with H/O hypo/hyperthyroidism (except replacement with thyroxine & on a
stable dose since the past 2 mths), repeated thyroid stimulating hormone (TSH) values
that is abnormal at screening or subjects with a H/O obesity of endocrine origin

4. Subjects with H/O anaphylaxis/angioedema, adult bronchial asthma, peptic ulcer &
clinically important food/drug allergy

5. Subjects with H/O drug abuse/addiction/use of recreational drugs ,mental handicap,
psychiatric disorders including eating disorders/seizures /significant head trauma

6. Subjects with H/O alcoholism for more than 2 years /consumption of more than 3
alcoholic drinks per day/consumption of alcohol, 2 days prior to confinement/ during
the study

7. Subjects with prior exposure to P11187/ have participated in previous cohorts or have
participated in another clinical trial 30 days prior to screening

8. Subjects undergone weight-loss surgery/ consuming prescription drugs including
sedatives &steroids within 30 days before first drug administration/ using
over-the-counter drugs including herbal/ health supplements & others such as St.
John's Wort extract . Subjects consumed weight loss medications within 90 days before
the first drug administration.

9. Part II- Subjects with using insulin within 6 mths prior to screening except when
used for short duration (less than 14 days) or was being treated with GLP-1 analogues
/ other anti-diabetic medications except metformin within 6 mths prior to screening.
Subjects being treated with herbal/OTC drugs including
sulfonylureas/alpha-glucosidase inhibitors unless discontinued/washed-out at least 14
days prior to dosing.Subjects on anti-hypertensive &lipid-lowering medications (only
statins) will only be allowed if they are at the same dose since the past 2 mths &
are maintained at the same dose throughout the study duration.

10. Part II-Subjects with H/O metabolic complications, mature Onset Diabetes of the Young
(MODY)/insulin-dependent type 2 diabetes mellitus/ other unusual forms of diabetes
mellitus. Subjects with known endocrine disorders

11. Part II-Subjects with H/O heart failure (NYHA class III &IV)/myocardial
infarction/unstable angina /cerebrovascular accident

12. Part II-Subjects with severe/uncontrolled hypertension(above 160/100 mm Hg)