A phase I clinical trial to study the safety tolerability, pharmacokinetics, food effect and pharmacodynamics of a new compound P7435 in in healthy, overweight and/or obese subjects
- Registration Number
- CTRI/2012/05/002691
- Lead Sponsor
- Piramal Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 96
1.Willingness and are able to provide a written informed consent to participate in the study.
2.Healthy adult male subjects aged between 18 and 45 (both inclusive) years old (Parts A and B). Healthy adult male subjects aged between 18 and 60 (both inclusive) years old (Part C).
3.BMI between 19 and 23 kg/m2 (Parts A and C only). Overweight (BMI between 23 and 25 kg/m2) and/or obese (BMI between 25 and 35 kg/m2) but otherwise healthy subjects in Part B only.
4.Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and 12-lead electrocardiograms (ECG).
5.Smoking less than 10 cigarettes per day and able to refrain from smoking during confinement.
6.Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, coke, chocolate, â??power drinksâ??) and grapefruit juice from 72 hrs prior to each admission until discharge and throughout the study.
7.Have a high probability for compliance with the study procedures including ability and willingness to swallow capsules during the study and ease of withdrawing blood samples.
8.All values of hematology and clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the investigator and discussed with the sponsor a priori
1.Employees of the Sponsor and CRO or clinical sites.
2.Female subjects
3.No past or current serious diseases of any organ will be allowed. Exceptions may be non-malignant skin diseases, childhood asthma and other conditions as per the investigatorâ??s discretion and discussed with the Sponsor a priori. History of significant gastrointestinal disease or other significant diseases including cardiac, renal or liver impairment.
4.History of sleep apnea, history of irregular sleep/wake cycle or working in night shifts.
5.Acute disease state (e.g. nausea, vomiting, fever, diarrhea) within 7 days before Day -2 of the study.
6.History of hypo or hyperthyroidism or repeated abnormal TSH values at screening, obesity of endocrine origin.
7.History of anaphylaxis or angioedema, bronchial asthma, peptic ulcer and clinically important food or drug allergy.
8.History of mental handicap, psychiatric disorders including eating disorders, seizures or significant head trauma.
9.History of drug abuse, addiction or use of recreational drug.
10.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 â?? one glass wine, half pint beer, one measure or ounce of spirit).
11.History of fainting from blood collections or vasovagal syncope.
12.Previous exposure to P7435 or participation in any of the previous cohorts.
13.Positive serology for human immunodeficiency virus (HIV-1/2) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
14.Positive findings in urine drug screen.
15.Positive finding in alcohol breath test.
16.Participation in another clinical trial within 90 days of the first drug administration.
17.Use of any prescription drugs including sedatives and steroids within 30 days before first drug administration. Use of any over-the-counter drugs including herbal supplements, health supplements, and others such as St. Johnâ??s Wort extract and other drugs causing pharmacokinetic interactions within 14 days before the first drug administration. Weight loss medications (including alternate medicine products) within 90 days before the first drug administration.
18.Intake of unusual diet e.g. low caloric, low sodium, for 30 days before first drug administration.
19.Intake of more than 8-10 cups of coffee and/or tea per day and consumption of methyl xanthine-containing beverages (tea, coffee, cola drinks, chocolate) within 48 hours prior to Day -1 of each study.
20.Donation of blood (i.e. 350 ml) within 90 days before Day â??1 of the first treatment period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability of single and multiple ascending doses of P7435 <br/ ><br>Effect of food on PK of P7435Timepoint: AEs <br/ ><br>Complete physical examination <br/ ><br>Clinical laboratory <br/ ><br>Vital signs including SBP and DBP, pulse rate and body temperature <br/ ><br>12-lead ECG and in triplicate <br/ ><br>For PD effects: <br/ ><br>-Fasting plasma glucose, insulin, C-peptide, Fasting serum lipids, Body weight, waist circumference, BMI, Serum adiponectin, serum leptin, Plasma glucose, insulin, C-peptide <br/ ><br>-Plasma GLP-1, GIP hormones, Serum lipids <br/ ><br>Urine samples for metabolite identification
- Secondary Outcome Measures
Name Time Method The pharmacokinetics of P7435 following single and multiple dosesTimepoint: Part A: <br/ ><br>pre-dose, 15 and 30 min and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 h post-dose <br/ ><br>Part B: <br/ ><br>pre-dose, 15 and 30 min and 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 h post-dose on Day 1; pre-dose, 15 and 30 min and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 h post-dose on Day 14