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

Purpose

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

Condition	Intervention	Phase
Healthy, Overweight and/or Obese Subjects	Drug: P7435	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Piramal Enterprises Limited:

Primary Outcome Measures:

Number of participants with adverse events [ Time Frame: Up to Day 5 ] [ Designated as safety issue: Yes ]
- Number of participants with adverse events in the single and multiple ascending dose studies.
Effect of food on drug concentrations [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics profile (Cmax, Tmax, and AUC) [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]
- 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

Other Outcome Measures:

Change from baseline in fasting glucose, insulin, C-peptide and lipids [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]

Estimated Enrollment:	96
Study Start Date:	May 2012
Estimated Study Completion Date:	May 2013
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: P7435 Tablets for once daily oral administration, For SAD part of the study dose would be 10 mg for Cohort 1; Cohorts 2, 3, 4 and 5 will be dosed subsequently at 30 mg, 100 mg, 300 mg, 1000 mg respectively Dose for MAD and food effects part of the study would be based on SAD study results	Drug: P7435 It is oral DGATI inhibitor with potential in dyslipidemia and T2DM
Placebo Comparator: Placebo Placebo tablets for oral administration	Drug: P7435 It is oral DGATI inhibitor with potential in dyslipidemia and T2DM

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

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764425

Locations

India
Piramal Clinical Research
Hyderabad, Andhra Pradesh, India, 500013
Veeda Clinical Research
Ahmedabad, Gujarat, India, 380015

Sponsors and Collaborators

Piramal Enterprises Limited

Investigators

Principal Investigator:	Dr Madhavi Latha Kodru
Principal Investigator:	Dr Dharmesh Domadia

More Information

No publications provided

Responsible Party:	Piramal Enterprises Limited
ClinicalTrials.gov Identifier:	NCT01764425 History of Changes
Other Study ID Numbers:	P7435/66/11
Study First Received:	December 20, 2012
Last Updated:	April 1, 2013
Health Authority:	India: Drugs Controller General of India

Keywords provided by Piramal Enterprises Limited:

P7435
Healthy,overweight and or obese subjects
Single ascending dose
Multiple ascending dose
Pharmacokinetics

Additional relevant MeSH terms:

Obesity
Overweight
Overnutrition

Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013