Clinical Trial to Study the Safety Tolerability, Pharmacokinetics, Food Effect & Pharmacodynamics of a New Compound P7435 in Healthy, Overweight and/or Obese Subjects

• Status: Terminated
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Piramal Enterprises Limited

Criteria

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.