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

Completed · Phase 1 · Has a placebo group

Conditions studied: Safety and Tolerability of EGT0001474 in Healthy Volunteers

In brief

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

Key facts

Study ID

NCT00854113

Run by

Theracos

People needed

78

Starts

2009-02-01

Expected to finish

2009-07-01

Last updated by the study team

2019-06-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Covance Clinical Research Unit — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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