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

Primary Purpose

Healthy, Overweight and/or Obese Subjects

Status

Terminated

Phase

Phase 1

Locations

India

Study Type

Interventional

Intervention

P7435

About this trial

This is an interventional treatment trial for Healthy, Overweight and/or Obese Subjects focused on measuring P7435, Healthy,overweight and or obese subjects, Single ascending dose, Multiple ascending dose, Pharmacokinetics

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Piramal Clinical Research
Veeda Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

P7435

Placebo

Arm Description

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

Placebo tablets for oral administration

Outcomes

Primary Outcome Measures

Number of participants with adverse events

- Number of participants with adverse events in the single and multiple ascending dose studies.

Effect of food on drug concentrations

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01764425

First Posted

December 20, 2012

Last Updated

July 8, 2013

Sponsor

Piramal Enterprises Limited

1. Study Identification

Unique Protocol Identification Number

NCT01764425

Brief Title

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

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Terminated

Study Start Date

May 2012 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Piramal Enterprises Limited

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Overweight and/or Obese Subjects

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

P7435

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo tablets for oral administration

Intervention Type

Drug

Intervention Name(s)

P7435

Intervention Description

It is oral DGATI inhibitor with potential in dyslipidemia and T2DM

Primary Outcome Measure Information:

Title

Number of participants with adverse events

Description

- Number of participants with adverse events in the single and multiple ascending dose studies.

Time Frame

Up to Day 5

Title

Effect of food on drug concentrations

Time Frame

Day 1

Secondary Outcome Measure Information:

Title

Pharmacokinetics profile (Cmax, Tmax, and AUC)

Description

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

Time Frame

Day 1 and Day 14

Other Pre-specified Outcome Measures:

Title

Change from baseline in fasting glucose, insulin, C-peptide and lipids

Time Frame

Day 1 and Day 14

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr Madhavi Latha Kodru

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dr Dharmesh Domadia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Piramal Clinical Research

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500013

Country

India

Facility Name

Veeda Clinical Research

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380015

Country

India

12. IPD Sharing Statement

Learn more about this trial

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

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