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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00989872

Enrollment

Registered

2009-10-06

Start date

Unknown

Completion date

Unknown

Last updated

2009-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methicillin-resistant Staphylococcus Aureus, Skin and Soft Tissue Infections

Keywords

Macrolides, Antibiotics, Safety, Tolerability, Pharmacokinetics, Phase I, MRSA/SSTI

Brief 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.

Interventions

DRUGEDP-322

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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...

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026