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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers

NCT00875628

Healthy Volunteers

TERMINATED PHASE1

Multiple Dose Safety Study of PF-04802540 in Healthy Volunteers

NCT00756743

Healthy

COMPLETED PHASE1

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of PF-06852231 in Healthy Subjects

NCT03217604

Healthy Volunteers

COMPLETED PHASE1

Definitive QT Study With MT-8554

NCT03471130

Healthy Volunteer

COMPLETED PHASE1

Dose Escalation Study of PF-06741086 In Healthy Subjects

NCT02531815

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Safety and Tolerability of EGT0001474 in Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EGT0001474

Ascending doses of EGT0001474

Group Type EXPERIMENTAL

EGT0001474

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match EGT0001474

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EGT0001474

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

Intervention Type DRUG

Placebo

Placebo to match EGT0001474

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Human SGLT2 inhibitor Human SGLT2 inhibitor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes