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Completed

NCT Number: NCT00854113

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

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

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Key information

Conditions

Safety and Tolerability of EGT0001474 in Healthy Volunteers Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EGT0001474

Drug

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

Other names: Human SGLT2 inhibitor

Placebo

Drug

Placebo to match EGT0001474

Other names: Human SGLT2 inhibitor

Primary outcomes

  1. Cmax

    Time frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days

    Pharmacokinetics results. Cmax -Maximum plasma drug concentration

  2. Tmax

    Time frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days

    Pharmacokinetics results. Time to maximum plasma drug concentration (Tmax) was calculated for each groups

  3. AUC 0-t

    Time frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days

    Pharmacokinetics results. AUC 0-t - Are under plasma concentration-time curve from time 0 time t.

  4. t1/2

    Time frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days

    Pharmacokinetics results.t 1/2 - apparent terminal half life

  5. AUC 0 -24

    Time frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days

    Pharmacokinetics results. Area under the plasma concentration-time curve from time 0 to 24 hours post-dose.

  6. Terminal Rate Constant.

    Time frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days

    Pharmacokinetics results. Terminal rate constant was estimated by linear regression of logarithmic transformed concentration versus time data

  7. CL/F

    Time frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days

    Pharmacokinetics results. Apparent oral clearance

  8. VZ/F

    Time frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days

    Pharmacokinetic results. Apparent volume of distribution

Sponsors and collaborators

Lead sponsor

Theracos

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 2, 2009
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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