Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy Volunteers

Methicillin-resistant Staphylococcus Aureus Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-Controlled, Ascending Single-Dose Safety, Tolerability, and Pharmacokinetics Study of EDP-322 in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989872
• Other study ID #: EDP-322-007-001
• Status: Completed
• Phase: Phase 1
• First received: October 5, 2009
• Last updated: October 5, 2009

Study information

• Verified date: October 2009
• Source: Enanta Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This was a randomized, double-blind, placebo-controlled, ascending single dose safety, tolerability, and pharmacokinetic study of orally administered EDP-322. This study was conducted at a single site. EDP-322 has a benefit to risk profile that supports testing in target patient populations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy adult males or females [if documentation existed that they were surgically sterilized].

• Were in good general health as determined by medical history, physical exam and clinical laboratory tests, and without evidence of clinically significant abnormality, in the opinion of the Investigator and Medical Monitor.

• The resting 12-lead ECG obtained at Screening shows no clinically significant abnormality and a QTc (Bazett's correction) <450 msec.

• Weight less than 132 pounds (60kg) with BMI between 18-32 kg/m3, inclusive.

• Subject has read, understood, and signed the written informed consent form.

Exclusion Criteria:

• History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances.

• History of gastric surgery, vagotomy, bowel resection, or any surgical procedure that might interfere with gastrointestinal motility, pH, or absorption.

• Any abnormal or screening clinical lab test results...

• Medication Related exclusions...

• Lifestyle related...

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Methicillin-resistant Staphylococcus Aureus
• Skin and Soft Tissue Infections
• Soft Tissue Infections
• Staphylococcal Infections

Intervention

Drug:
• EDP-322

Locations

Country	Name	City	State
United States	PPD Phase I Unit	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The study objectives included determining the safety, tolerability and pharmacokinetics of single oral doses of EDP-322 in healthy adult volunteers