Clinical trial NCT01764425: Clinical Trial to Study the Safety Tolerability, Pharmacokinetics, Food Effect & Pharmacodynamics of a New Compound P7435 in Healthy, Overweight and/or Obese Subjects
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy, Overweight and/or Obese Subjects
Keywords: P7435
Healthy,overweight and or obese subjects
Single ascending dose
Multiple ascending dose
Pharmacokinetics
Lead sponsor: Piramal Enterprises Limited
Sponsor class: INDUSTRY
First posted: 2013-01-09
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: * A phase I, randomized, double-blind, placebo-controlled, dose escalating study of P7435 to determine the safety, tolerability, pharmacokinetics, food effect and pharmacodynamics of single and multiple ascending doses of P7435.
* Subjects participating will be either healthy subjects or healthy overweight and/or obese subjects. In this study, overweight/obese are defined as subjects having a BMI of 23 kg/m2 and above.
* The study will be conducted in 3 parts as follows: Part A will consist of the Single Ascending Dose (SAD) study, Part B will consist of the Multiple Ascending Dose (MAD) study and Part C will consist of the Food Effect study.

Eligibility 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.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to Day 5
measure: Effect of food on drug concentrations
timeFrame: Day 1
Secondary outcomes:
measure: Pharmacokinetics profile (Cmax, Tmax, and AUC)
timeFrame: Day 1 and Day 14
Other outcomes:
measure: Change from baseline in fasting glucose, insulin, C-peptide and lipids
timeFrame: Day 1 and Day 14
Locations:
city: Hyderabad
country: India
facility: Piramal Clinical Research
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Veeda Clinical Research
state: Gujarat
Study officials:
name: Dr Madhavi Latha Kodru
role: PRINCIPAL_INVESTIGATOR
name: Dr Dharmesh Domadia
role: PRINCIPAL_INVESTIGATOR
References: