Safety concerns
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.
Sponsor study identifier
Secondary identifiers
REGISTRY · Clinical Trial Registration India
interventional
24
1 country
1
Study Start
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2012
Actual (reported)Study Completion
July 2012
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2012
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
February 21, 2012
Actual (reported)March 2, 2012
Actual (reported)July 2012
Actual (reported)July 2012
Actual (reported)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.
14 Days
Pharmacokinetics (PK) (Plan I, II, III, IV) and pharmacodynamics (PD)(Plan II)
14 days
ZYT1 tablets: Route of administration: Oral Dosage: 0.5mg, 1mg, 2 mg, 4mg, 8 mg, 16mg, 32mg and 64mg
Placebo tablets: Route of administration: Oral Dosage: 0.5mg, 1mg, 2 mg, 4mg, 8 mg, 16mg, 32mg and 64mg
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, 382213, India
Rajendrakumar H Jani, PhD(Medical)
Zydus Research Centre, Cadila Healthcare Limited,Moriya, Ahmedabad-382213, Gujrat, India
24 participants (actual enrollment reported by the registry).
First Submitted
February 21, 2012
First Posted
March 2, 2012
Study Start
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
A Study to Characterize Event Related Potential Markers of Attentional Bias Towards Words and Images of Food
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Primary Completion
July 2012
Actual (reported)Study Completion
July 2012
Actual (reported)Last Updated
November 24, 2015
Record last verified: 2015-11
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Source: ClinicalTrials.gov.
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