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

Theracos78 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Safety and Tolerability of EGT0001474 in Healthy Volunteers

Interventions

EGT0001474DRUG

Oral ascending doses given daily as capsules for up to 14 days

PlaceboDRUG

Placebo to match EGT0001474

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female volunteers between the ages of 18 and 55 years inclusive. * In good health. * Female subjects must be surgically sterilized or postmenopausal. * Body mass index (BMI) between 18 kg/m2 and 30 kg/m2 inclusive. * Non-smoker. * Negative drug and alcohol screens. Exclusion Criteria: * Abnormal ECG * Sitting blood pressure above 140/90 mmHg on 2 evaluations at least 10 minutes apart at screening * Treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer. * Previous treatment with EGT0001474. * History of drug abuse. * Febrile illness within 5 days prior to the first dose of study medication.

Locations (1)

Covance Clinical Research Unit

Madison, Wisconsin, United States