Phase-I bridging study of TRC041266 Powder in healthy human subjects.

Phase 1

• Registration Number: CTRI/2020/04/024708
• Lead Sponsor: Dr Sanjay Sharma

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: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male and/or female subjects aged 18-65 years (both inclusive)

2. Volunteer with BMI of 18.5-30 kg/m2 (inclusive both) with minimum weight of 50 kg

3. Volunteer willing to provide written informed consent.

4. Ability to adhere to the study restrictions and assessments schedule

Exclusion Criteria

1. Inability to communicate or co-operate

2. History of angina, myocardial infarction (MI) or stroke within last 3 months prior to screening

3. Volunteers suffering from any chronic illness such as arthritis, asthma etc.

4. History of pre-existing bleeding disorder

5. Clinically relevant abnormal physical findings at the screening examination,

which would interfere with the objectives of the study

6. Clinically significant abnormalities in the results of the clinical laboratory tests (at screening or check-in day (i.e. Day-0))

7. Clinically significant abnormal ECG (at screening), 2D Echo or Chest X-ray

8. Pregnant or lactating women or female subjects who are of childbearing

potential and who are neither surgically sterilized nor willing to use reliable

contraceptive methods {i) bilateral tubal occlusion; ii) vasectomised partner and iii) sexual abstinence iv) barrier method of contraception} and/or female volunteer with positive urine pregnancy test

9. Smokers who are unable to stop tobacco consumption during each study period, or smokers who smokes >10 cigarettes (or equivalent) per Day during last 3 months prior to Day 1

10. Positive for HIV, HCV and HbsAg.

11. History of significant blood loss due to any reason, including blood donation in the past 3 months; or the total blood loss in the last 3 months, including for this study, exceeds 450 ml.

12. Participation in any study within past 3 months

13. Addiction to alcohol or history of alcohol or drug abuse

14. Intake of hepatic microsomal enzyme inducer/inhibitor drugs in the period

within 3 months prior to the first dose of study drug

15. History of consumption of prescribed medication since last 14 days or OTC medication/ herbal remedies since last 7 days before beginning of the study.

16. Volunteer found to be positive for breath alcohol test.

17. History of malignancy

18. Volunteer found to be positive for opiate, tetrahydrocannabinoid, amphetamine, barbiturates, benzodiazepines, cocaine based on urine test.

19. Systolic blood pressure less than 100 mmHg or more than 139 mmHg and diastolic blood pressure less than 60 mmHg or more than 89 mmHg.

20. Pulse rate less than 60/minute or more than 100/minute.

21. Oral temperature less than 95°F or more than 98.9°F.

22. Respiratory rate less than 10/minute or more than 20/minute.

23. History of hypersensitivity reaction/allergy to the investigational product or any drug chemically similar to the drug under investigation or any of the

excipients.

24. Recent history of kidney or liver dysfunction.

25. Volunteers suffering from any psychiatric (acute or chronic) disorder.

26. Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator /physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers

27. Volunteers with left ventricular ejection fraction (LVEF) < 55%

28. Serum magnesium level more than 2.6 mg/dl in male and 2.5 mg/dl in female.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the oral pharmacokinetics of TRC041266 <br/ ><br>powder with TRC4186 tabletTimepoint: Day 1: 0.00 (pre-dose),0.25, 0.50, 1.00, 1.50, 2.00,2.50, <br/ ><br>3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00 (pre-dose) (15 samples) <br/ ><br> <br/ ><br>Day 2-6: 0.00 pre-dose (morning) and 12.00 pre-dose <br/ ><br>(evening) (10 samples) <br/ ><br> <br/ ><br>Day 7: 0.00 (pre-dose),0.25, 0.50, 1.00, 1.50, 2.00, 2.50,3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 24.00 hr(Day 8), 48 hr (Day 9) (17 samples).

Secondary Outcome Measures

Name	Time	Method
a) To evaluate the safety and tolerability of TRC041266 powder in healthy human subjects. <br/ ><br> <br/ ><br>b) To evaluate the pharmacokinetic parameters of metabolite M4Timepoint: TRC041266 and metabolite M4 concentration data for study Day-1 and Day-7 (from 12 hrs <br/ ><br>after morning dose). <br/ ><br> <br/ ><br>Additional pharmacokinetic parameters based on full sampling (0-48 hrs)