Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy Volunteers
Primary Purpose
Skin and Soft Tissue Infections, Methicillin-resistant Staphylococcus Aureus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EDP-322
Sponsored by
About this trial
This is an interventional treatment trial for Skin and Soft Tissue Infections focused on measuring Macrolides, Antibiotics, Safety, Tolerability, Pharmacokinetics, Phase I, MRSA/SSTI
Eligibility 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...
Sites / Locations
- PPD Phase I Unit
Outcomes
Primary Outcome Measures
The study objectives included determining the safety, tolerability and pharmacokinetics of single oral doses of EDP-322 in healthy adult volunteers
Secondary Outcome Measures
Full Information
NCT ID
NCT00989872
First Posted
October 5, 2009
Last Updated
October 5, 2009
Sponsor
Enanta Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT00989872
Brief Title
Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy Volunteers
Official Title
A Randomized, Double-blind, Placebo-Controlled, Ascending Single-Dose Safety, Tolerability, and Pharmacokinetics Study of EDP-322 in Healthy Adult Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Enanta Pharmaceuticals, Inc
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin and Soft Tissue Infections, Methicillin-resistant Staphylococcus Aureus
Keywords
Macrolides, Antibiotics, Safety, Tolerability, Pharmacokinetics, Phase I, MRSA/SSTI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
EDP-322
Primary Outcome Measure Information:
Title
The study objectives included determining the safety, tolerability and pharmacokinetics of single oral doses of EDP-322 in healthy adult volunteers
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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...
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas L Hunt, MD, PhD
Organizational Affiliation
PPD Phase I Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
PPD Phase I Unit
City
Austin
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy Volunteers
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