NCT01472809

A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral ZYGK1 in Healthy Volunteers

A Randomized, Double Blind Placebo Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZYGK1, a Novel Glucokinase Activator, Following Oral Administration in Healthy Volunteers

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Zydus Lifesciences Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine (1) whether ZYGK1 is safe and well tolerated, (2) the pharmacokinetics (what body does to ZYGK1) and (3) pharmacodynamics (what drugs does to the body) in the healthy and diabetic subject.

Detailed description

This study will be a randomized, double blind, placebo controlled study and is divided into four plans: 1. Plan I: Single Ascending Dose (SAD) Study 2. Plan II: Multiple Ascending Dose (MAD)Study 3. Plan III: Gender Effect study 4. Plan IV: Food Effect study First Plan I, Plan III and Plan IV will be conducted in healthy volunteers. After reviewing the results, decision shall be taken whether the multiple ascending doses shall be studied in healthy human volunteers or in subjects with type 2 diabetes.

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	ZYGK1	ZYGK1 Tablets: 0.125, 0.25, 0.5, 1, 2, .... mg. Dose escalation will continue till single AE occurs in any block of 3 volunteers on ZYGK1 or pharmacokinetic (dose linearity) saturation is reached or desired PK/PD effect is achieved
DRUG	Placebo	Placebo Tablets: 0.125, 0.25, 0.5, 1, 2, ... mg

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-12-01
• First posted: 2011-11-17
• Last updated: 2015-11-24

Locations

1 site across 1 country: India