A Clinical Study to Evaluate the Safety,Tolerability & PK of ZYT1,

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01543269
Study type	Interventional
Source	Cadila Healthcare Limited
Contact
Status	Terminated
Phase	Phase 1
Start date	February 2010
Completion date	July 2012

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Clinical Study to Evaluate the Safety,Tolerability and PK of ZYT1, Following Oral Administration in Healthy Volunteers

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms