Phase I Multiple Ascending Dose study of TRC150094 on overweight/obese male and female subjects.

Phase 1

Completed

• Conditions: Health Condition 1: null- Metabolic Syndrome

• Registration Number: CTRI/2009/091/000601
• Lead Sponsor: Torrent Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

1. Medical history, physical examination, vital signs, clinical laboratory tests, 12-lead ECG and Chest X ray without significant abnormalities, in the opinion of the investigator

2. Overweight/obese adult male and female in the age range 18-65 years, inclusive, with a BMI in the range 27-35 kg/m2, inclusive

3. Waist circumference: men more than or equal to 90 cm, women more than or equal to 80 cm

4. Subjects with Non-alcoholic Fatty liver Grade 1-3 based on Magnetic Resonance Spectroscopy. (Ref Qayyum A)

5. Fasting serum insulin more than or equal to 10mU/ml and Fasting plasma glucose >100 mg/dl

6. Blood pressure: SBP more than or equal to 130 mmHg or DBP more than or equal to 85 mmHg or subjects

receiving anti-hypertensive treatment

7. Serum triglyceride (fasting) more than or equal to 150 mg/dL

8. Female subjects will include with/without childbearing potential using highly effective method of contraception except OCPs from at least 15 days prior to enrolment till 10 days after administration of last dose.

9. Negative drugs of abuse test and negative alcohol breath test

10. Non-smokers or current smokers who have been smoking less than 10 cigarettes (or equivalent) per day on a stable basis for at least 3 months prior to Day 1 and who are willing to stop smoking / tobacco intake during the study period(s).

11. Ability to communicate well with the investigator and to comply with the requirements of the entire study.

12. Willingness to give written informed consent (prior to any studyrelated procedures being performed) and ability to adhere to the study restrictions and assessments schedule.

Exclusion Criteria

1. Clinically relevant abnormal physical findings at the screening
examination, which would interfere with the objectives of the study.
2. Clinically significant abnormalities in the results of the clinical
laboratory tests (at screening or Day (-1).
3. eGFR < 60 mL/min/1.73m2 as evaluated by Modification of Diet in Renal Disease (MDRD) method.
4. History of angina, Myocardial Infarction (MI) or stroke since last 6 months.
5. Angina or evidence of myocardial ischemia in ECG during CPET
6. Severe joint disease or peripheral arterial disease sufficient to impede exercise testing
7. Clinically relevant abnormalities in the 12-lead ECG (at screening or Day -1).
8. Hypertension with SBP/DBP more than or equal to 170/110 m Hg.
9. ALT or AST more than or equal to ULN*3
10. History or presence of malignancy.
11. Addiction to alcohol or history of any alcohol or drug abuse.
12. History of allergy to the test drug or any drug chemically similar to the drug under investigation.
13. Positive for HIV I, HIV II, hepatitis C antibody or HBsAg.
14. Positive for urine drugs of abuse test (at screening or Day -1).
15. Subjects suffering from any psychiatric (acute or chronic) illness.
16. Intake of any medication except those permitted in this study
17. Intake of any investigational drug in the period within 3 months prior to the first dose of study drug.
18. History of significant blood loss due to any reason, including blood donation, in the 12 weeks prior to the first dose of study drug; or the total blood loss in the last 3 months, including for this study, exceeds 450 mL.
19. History of any bleeding disorder.
20. Existence of any surgical or medical condition which, in the judgment of the principal investigator, might interfere with the absorption, distribution, metabolism or excretion of the study drug or might be likely to compromise the safety of the subject.
21. Inability to communicate or co-operate with the investigator because of language problems, poor mental development or impaired cerebral function.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of ascending multiple doses of TRC150094 in overweight/obese male and female volunteers. It includes physical examination, clinical laboratory tests, vital signs and 12-lead ECG.Timepoint: PHYSICAL EXAMINATION: Day -2,Day 7, 14, 21, 30, post study follow-up visit. CLINICAL LABORATORY TESTS: Day −1, Day 7: pre-dose (before dosing), Day 14: pre-dose (before dosing), Day 21: pre-dose (before dosing), Day 29: 24 hour post dose (after dosing on Day 28), post-study follow-up visit. VITAL SIGNS: Day -2,Day -1, Day 1: pre-dose (0), 0.5, 1, 2, 4, 6, 8, 12, 24, Day 2-27: at 12 hr intervals, Day 28: pre-dose (0), 0.5, 1, 2, 4, 6, 8, 12, 24, Day29-30: at 12 hr intervals, Post-study follow-up visit. 12-LEAD ECG: Day -2, Day -1, Day 1: pre-dose (0), 0.5, 1, 4, 8 and 12 hours post-dose, Day 2-30: 24 hr intervals, Post-study follow-up visit.