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

NCT01764425 | Terminated Phase 1

• 1 other identifier: P7435/66/11
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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

Conditions

Healthy, Overweight and/or Obese Subjects

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number of participants with adverse events

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

  Up to Day 5

• Effect of food on drug concentrations

  Day 1

Secondary Outcomes (1)

• Pharmacokinetics profile (Cmax, Tmax, and AUC)

  Day 1 and Day 14

Other Outcomes (1)

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

  Day 1 and Day 14

Study Arms (2)

P7435

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Placebo tablets for oral administration

Drug: P7435

Interventions

P7435 DRUG

It is oral DGATI inhibitor with potential in dyslipidemia and T2DM

P7435; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Piramal Enterprises Limited: lead

Study Sites (2)

Piramal Clinical Research

Hyderabad, Andhra Pradesh, 500013, India

Location

Veeda Clinical Research

Ahmedabad, Gujarat, 380015, India

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Madhavi Latha Kodru

  PRINCIPAL INVESTIGATOR

• Dr Dharmesh Domadia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: January 9, 2013
• Study Start: May 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: February 1, 2013
• Last Updated: July 9, 2013

Record last verified: 2013-07

Locations

IN (2)