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

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.

Timeline

Start

2010-02

Primary completion

2012-07

Completion

2012-07

Outcome

Outcome not reported

Stopped: “Safety concerns”

Drugs

Indications