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

Status unconfirmed · Phase 1 · Has a placebo group

Conditions studied: Overweight, Diabetes Mellitus Type 2 in Obese

In brief

* Study to Determine the Safety, Tolerability, Pharmacokinetics, Food Effect and Pharmacodynamics of Single and Multiple Ascending Doses of P11187 * It will be conducted in three parts, as described below: * Part I will be the Single Ascending Dose (SAD) study * Part II will be the Multiple Ascending Dose (MAD) study * Part III will be the food effect evaluation

Key facts

Study ID

NCT01874366

Run by

Piramal Enterprises Limited

People needed

96

Starts

2013-06-01

Expected to finish

2015-12-01

Last updated by the study team

2014-08-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects willing to give written informed consent to participate in the study
• Male \& female subjects aged between 18 \&70 years (both inclusive) in Part I \& II) \& between 18 \&70 years (both inclusive) in Part III
• 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)
• Healthy subjects having no clinically significant abnormalities in medical history, physical examination, clinical laboratory tests, vital signs \& 12-lead electrocardiograms (ECG)
• Female subjects of non-child-bearing potential, post-menopausal or surgically sterilized (Part I \& II)
• Male subjects agreed to use contraceptive methods as per protocol during \& approximately 30 days after the exit/completion of their participation in the study
• Part II: Subjects with type 2 diabetes mellitus at least 6 mths prior to screening
• 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.
• Part II-Subjects with HbA1c between 6 \&11% at screening
• Part II-Subjects with fasting plasma glucose of ≤ 14.42 mmol/L (\~260 mg/dL) at screening
• Part II-Subjects with C-peptide value of > 0.266 nmol/L (0.8 ng/mL) at screening

You may not qualify if…

• Subjects with history of (H/O) significant gastrointestinal, cardiac, renal or liver impairment
• Subjects with known congenital QTc prolongation or QTcF greater than 450 ms
• 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
• Subjects with H/O anaphylaxis/angioedema, adult bronchial asthma, peptic ulcer \& clinically important food/drug allergy
• Subjects with H/O drug abuse/addiction/use of recreational drugs ,mental handicap, psychiatric disorders including eating disorders/seizures /significant head trauma
• 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
• Subjects with prior exposure to P11187/ have participated in previous cohorts or have participated in another clinical trial 30 days prior to screening
• 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.
• 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.
• 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
• Part II-Subjects with H/O heart failure (NYHA class III \&IV)/myocardial infarction/unstable angina /cerebrovascular accident
• Part II-Subjects with severe/uncontrolled hypertension(above 160/100 mm Hg)

Where it is running

• Phase I clinic: MRA Clinical Research — Miami, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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