A clinical trial to study the tolerability and safety of ZYT1, an investigational drug in human volunteers
- Registration Number
- CTRI/2008/091/000256
- Lead Sponsor
- Zydus Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 8
1.Age: 18-45 years
2.Mentally, physically and legally eligible to give informed consent.
3.Male and female volunteers weighing between 50-75kg and 45-75kg respectively.
4.Ability to communicate effectively with the study personnel.
5.Willingness to adhere to the protocol requirements.
6.Normal Thyroid Function Tests (free and total T3, free and total T4 and TSH)
7.Lipid criteria: Low density lipoprotein (LDL) cholesterol up to 160mg/dL and triglyceride (TG) level up to 500mg/dL
8.For gender effect study, only females with history of sterility or one year menopause or use of long acting non-hormonal contraceptive measures (e.g., Intra uterine device) will be recruited.
1.Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYT1 formulation.
2.History of thyroid disorders (any form) within 24 weeks prior to the recruitment in the study.
3.Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal (ULN).
4.Renal insufficiency (serum creatinine > 1.5mg/dL).
5.History of myocarditis, hypertrophic cardiomyopathy, valvular heart disease, restrictive cardiomyopathy, constrictive pericarditis, myocardial infarction, ischemic heart disease, stroke, congestive heart failure, cardiac arrhythmia or coronary revascularization procedure at any time.
6.Subject who has QTc  450 (male) or 470 (female).
7.History or presence of musculo-skeletal disorders (e.g., myopathies, myolysis, fractures due to osteoporosis, etc.)
8.History or presence of other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement).
9.Subjects taking other hormonal therapies e.g., glucocorticoids, androgens or growth hormones.
10.Use of thyroid supplements (levothyroxine, liothyronine, etc.) or any preparation containing thyromimetic agents within 24 weeks prior to study entry.
11.History of coagulopathy or use of anticoagulants such as warfarin.
12.History or presence of chronic medications or any medications in the last 14 days.
13.History or presence of significant alcoholism or drug abuse within the past one-year.
14.History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products (more than 10 times per day).
15.Difficulty with donating blood.
16.Systolic blood pressure more than 140mmHg and less than 100mmHg and diastolic blood pressure more than 90mmHg and less than 60mmHg.
17.Pulse rate less than 60/minute and more than 100/minute.
18.Any clinically significant abnormal X-ray or laboratory findings during screening.
19.History or presence of any clinically significant ECG abnormalities during screening.
20.Major illness and/or Major surgery in last 3 months.
21.Volunteers who have participated in any drug research study other than the present trial within past 3 months.
22.Volunteers who have donated one unit (350ml) of blood in the past 3 months.
23.For gender effect study, female volunteers with following criteria will not be recruited:
a.History of pregnancy or lactation in the past 3 months
b.Fertile female volunteers not protected against pregnancy by adequate long-term anti- fertility device or history of less than one year of menopause
c.Using hormonal contraceptives
d.Using hormone replacement therapy
e.Unable to give assurance for protection against pregnancy for 3 months after the participation in this trial
f.History of osteoporosis or history of fracture in the past 6 months
g.Positive urine pregnancy test on the day of check-in
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate-<br>1.Safety and tolerability of ZYT1. <br>2.Pharmacokinetics (PK) of ZYT1 after single and multiple oral dose administrations in healthy adult male volunteers.<br>3.Pharmacodynamic (PD) effect, if captured, in multiple dose study.<br>4.Effect of food on pharmacokinetics in male volunteers.<br>5.Gender effects: Pharmacokinetics and safety parameters in female volunteers at pre-selected single dose will be compared with the results of single dose study in male volunteers.<br>Timepoint: 1.FOR PLAN I, III, IV:<br>Blood Sampling for PK analysis-Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hrs post dose.<br>2.FOR PLAN II:<br>Pharmacodynamic assessment-Pre-dose on Day 01, 05 and 10<br>Blood Sampling for PK analysis-<br>?Day 1, 5, 9: pre-dose, 0.5hr, 1hr, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs of dosing<br>?Day 2 to 13: predose<br>?Day 14: pre-dose, 0.5hr, 1hr, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 48hrs, 72hrs and 120 hrs of dosing.<br><br>
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI