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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

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

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

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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