Status:
COMPLETED
Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of EGT0001474 in Healthy Volunteers
Lead Sponsor:
Theracos
Conditions:
Safety and Tolerability of EGT0001474 in Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00854113
Start Date
February 1 2009
End Date
July 1 2009
Last Update
June 6 2019
Active Locations (1)
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1
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53704