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Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT00989872•Enanta Pharmaceuticals, Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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...

Locations (1)

PPD Phase I Unit

Austin, Texas, United States

Key Dates

Last Updated

October 6, 2009

Enrollment

ACTUAL participants

Conditions

Skin and Soft Tissue InfectionsMethicillin-resistant Staphylococcus Aureus

Interventions

EDP-322

DRUG

PMT for MDRO Decolonization

NCT05632315

Multidrug Resistant Bacterial InfectionEnterobacteriaceae Infections+3 more

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COMPLETEDPHASE4

Animal-Assisted Visitation Program Chlorhexidine Trial

NCT04171817

Methicillin-resistant Staphylococcus AureusClostridium Difficile+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

PMT for MDRO Decolonization

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