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

Theracos

Status and phase: Completed; Phase 1

Conditions: Safety and Tolerability of EGT0001474 in Healthy Volunteers

Treatments: Drug: EGT0001474; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00854113

THR-1474-C-328

Details and patient eligibility

About

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

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups, including a placebo group

EGT0001474

Experimental group

Description:

Ascending doses of EGT0001474

Treatment:

Drug: EGT0001474

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo