This is a clinical study to evaluate the safety, tolerability and pharmacokinetics of ZYT1, following oral administrations in healthy volunteers. The study shall be divided into four plans as given below: 1. Plan I: Single dose escalation trial 2. Plan II: Multiple dose escalation trial 3. Plan III: Food effect trial. 4. Plan IV: Gender Effect trial. The safety and tolerability shall be evaluated using physical examinations, Standard laboratory tests (hematology, biochemistry and urine examination), electrocardiogram (ECG) and thyroid scanning. Spontaneously reported and solicited adverse events will also be used for safety parameters.
This is a clinical study to evaluate the safety, tolerability and pharmacokinetics of ZYT1, following oral administrations in healthy volunteers. The study is divided into four plans as given below: 1. Plan I: Single dose escalation trial: A study is to evaluate safety, tolerability and PK of ZYT1 in healthy volunteers. 2. Plan II: Multiple dose escalation trial: A study is to evaluate safety, tolerability, PK and, if demonstrated, capture the Pharmacodynamics of ZYT1 in healthy volunteers. 3. Plan III: Food effect trial Effect of food on pharmacokinetics will be studied in a cross over study, with selected dose and based on limit of detection of the investigational medicinal product (IMP) in analytical methods. 4. Plan IV: Gender Effect trial . The gender effect study will be conducted after the completion of Panel S5 of single dose safety and tolerability study The safety and tolerability shall be evaluated using physical examinations, Standard laboratory tests (hematology, biochemistry and urine examination), electrocardiogram (ECG) and thyroid scanning. Spontaneously reported and solicited adverse events will also be used for safety parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Oral dose of ZYT1 in fasting condition with 240±10 ml of water at sitting position in ambient temperature.
Oral dose of Placebo in fasting condition with 240±10 ml of water at sitting position in ambient temperature.
Zydus Research Centre, Cadila Healthcare Limited
Ahmedabad, Gujarat, India
Safety and tolerability of ZYT1 (Plan I-IV)
Safety and tolerability for Plan I, II,III and IV (Time Frame upto 14 days) The safety and tolerability shall be evaluated using physical examinations, Standard laboratory tests (hematology, biochemistry and urine examination), electrocardiogram (ECG) and thyroid scanning. Spontaneously reported and solicited adverse events will also be used for safety parameters. Safety will be assessed by noting the number of subjects who will develop Adverse Event (AE) along with severity and causality assessment.
Time frame: 14 Days
Pharmacokinetics (PK) (Plan I, II, III, IV) and pharmacodynamics (PD)(Plan II)
PK parameters: Plan I, III, IV:Cmax, Tmax, Area Under the Curve (AUC)0-t, AUC 0-inf, T1/2, λz, Clearance (CL), Vd Plan II:Cmin, Tmin, Cavg, % Fluctuation, Accumulation Index, Clss, Cmax, volume of distribution (VZ) or Vss For urine data (Plan I, II, III, IV):Amount recovered, recovered PD Parameters assessed include Bld glucose, TG, Total Chol., HDL, LDL, very low-density lipoprotein (VLDL), free fatty acid (FFA), Lipoprotein (a), Wt reduction, if any, after Plan II. Values compared for pre Rx and post Rx levels. PD Analysis made for differences among Rx groups as well as comparing Rx group with placebo.
Time frame: 14 days
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