NCT01543269

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

A Randomized, Double Blind, Placebo Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZYT1, a Selective Thyroid Receptor (TR) ß Agonist, Following the Oral Administrations in Healthy Volunteers.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Zydus Lifesciences Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Obesity
• Lipid Disorders

Interventions

Type	Name	Description
DRUG	ZYT1	Oral dose of ZYT1 in fasting condition with 240±10 ml of water at sitting position in ambient temperature.
DRUG	Placebo tablets	Oral dose of Placebo in fasting condition with 240±10 ml of water at sitting position in ambient temperature.

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-03-02
• Last updated: 2015-11-24

Locations

1 site across 1 country: India