Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Enanta Pharmaceuticals
Criteria
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...