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

Enanta Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Methicillin-resistant Staphylococcus Aureus; Skin and Soft Tissue Infections

Treatments: Drug: EDP-322

Study type: Interventional

Funder types: Industry

Identifiers

NCT00989872

EDP-322-007-001

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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...