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

NCT00989872 | Completed Phase 1

• 1 other identifier: EDP-322-007-001
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin and Soft Tissue Infections; Methicillin-resistant Staphylococcus Aureus

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Interventions

EDP-322 DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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...
• Lifestyle related...

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (1)

PPD Phase I Unit

Austin, Texas, United States

Location

MeSH Terms

Conditions

Soft Tissue Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Thomas L Hunt, MD, PhD

  PPD Phase I Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 6, 2009
• Last Updated: October 6, 2009

Record last verified: 2009-10

Locations

US (1)