NCT00854113

Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of EGT0001474 in Healthy Volunteers

A Phase I , Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of EGT0001474 In Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Theracos · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study evaluated the safety, tolerability and pharmacokinetics of single or multiple doses of EGT0001474.

Detailed description

EGT0001474 is an inhibitor of human sodium dependent glucose co-transporter II being developed for the treatment of Type II Diabetes mellitus. This is a singe center, Phase-1, double blinded,placebo controlled, dose escalation study of single and multiple ascending doses of EGT0001474 in healthy male and female subjects. In part-1, subjects were randomized to receive single doses of EGT0001474 at 2.5-150 mg or placebo in the ratio of 3:1. In part-2, subjects were randomized to receive 14 daily doses of EGT0001474 at 10, 50 and 150 mg or placebo in the ratio of 4:1. When the various doses were analysed, the maximum dose 150 mg was found to be tolerable. Although there was no serious adverse events, mild adverse events were observed. This study provided information on human safety, tolerability, PK and pharmacodynamic effects of EGT0001474.

Conditions

• Safety and Tolerability of EGT0001474 in Healthy Volunteers

Interventions

Type	Name	Description
DRUG	EGT0001474	Oral ascending doses given daily as capsules for up to 14 days
DRUG	Placebo	Placebo to match EGT0001474

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2009-03-02
• Last updated: 2019-06-06
• Results posted: 2011-08-12

Locations

1 site across 1 country: United States