Healthy, Overweight and/or Obese Subjects Clinical Trial
Official title:
A Phase I, Randomized, Double-blind, Placebo-controlled Study to Determine the Safety, Tolerability, Pharmacokinetics, Food Effect and Pharmacodynamics of Single and Multiple Ascending Doses of P7435 in Healthy, Overweight and/or Obese Subjects
| Verified date | July 2013 |
| Source | Piramal Enterprises Limited |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | India: Drugs Controller General of India |
| Study type | Interventional |
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
| Status | Terminated |
| Enrollment | 32 |
| Est. completion date | February 2013 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Willingness and are able to provide a written informed consent to participate in the study. - Healthy adult male subjects aged between 18 and 45 (both inclusive) years old - BMI between 19 and 23 kg/m2. Overweight (BMI between 23 and 25kg/m2) and/or obese (BMI between 25 and 35 kg/m2) but otherwise healthy subjects in PartB . - Healthy as determined by the investigator - Smoking less than 10 cigarettes per day and able to refrain from smoking during confinement. - Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, coke, chocolate, "power drinks") and grapefruit juice to admission. Exclusion Criteria: - Employees of the sponsor or clinical sites. - Female subjects. - 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 Investigator's discretion and discussed with the Sponsor a priori. History of significant gastrointestinal disease or other significant diseases including cardiac, renal or liver impairment. - History of sleep apnea, irregular sleep/wake cycle or working in night shifts. - Acute disease state - History of hypo/hyperthyroidism or repeated abnormal TSH values at screening or obesity of endocrine origin. - History of alcoholism for more than 2 years - Positive serology for human immunodeficiency virus (HIV-1/2) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies. - Positive findings in urine drug screen / alcohol breath test. - Participation in another clinical trial within 90 days of the first drug administration. - 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 study. - Donation of blood (i.e. 350 ml) within 90 days before Day -1 of the first treatment period. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| India | Veeda Clinical Research | Ahmedabad | Gujarat |
| India | Piramal Clinical Research | Hyderabad | Andhra Pradesh |
| Lead Sponsor | Collaborator |
|---|---|
| Piramal Enterprises Limited |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change from baseline in fasting glucose, insulin, C-peptide and lipids | Day 1 and Day 14 | No | |
| Primary | Number of participants with adverse events | - Number of participants with adverse events in the single and multiple ascending dose studies. | Up to Day 5 | Yes |
| Primary | Effect of food on drug concentrations | Day 1 | Yes | |
| Secondary | Pharmacokinetics profile (Cmax, Tmax, and AUC) | The PK profile will be derived from the P7435 plasma concentration data. A non compartmental model will be used to analyze the plasma levels of P7435 |
Day 1 and Day 14 | No |