Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT01874366
Eligibility Criteria:
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01874366
Study Brief:
Protocol Section:
NCT01874366