Multiple Ascending-Dose Study of EDP 322 in Healthy Adult... | NCT00990145

Studies
Multiple Ascending-Dose Study of EDP 322 in Healthy Adult Volunteers

NCT00990145

Sponsor

Enanta Pharmaceuticals, Inc

Status

Completed

Last Update Posted

Oct 8, 2009Estimated

Enrollment

52Actual

Phase

Phase 1

Conditions

MRSA, SSTI

Interventions

EDP-322

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Nov 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Oct 5, 2009

First Submission Date that Met QC Criteria

Oct 5, 2009

First Posted Date

Oct 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2009

Last Update Posted Date

Oct 8, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This was a Phase I, single-center, randomized, double-blind, placebo-controlled, ascending multiple dose study to evaluate the safety, tolerability, and pharmacokinetics of orally administered EDP-322 in healthy adult volunteers.

Detailed Description

Fifty-two subjects were enrolled into 6 cohorts. Six subjects of each cohort were randomized to received EDP-322 and 2 subjects of each cohort received placebo. Each cohort received the study drug once daily (QD) for 7 days under fed conditions. Multiple oral doses of EDP 322 ranging from 200 to 800 mg were safe and generally well tolerated by the healthy male and female subjects in this study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Label	Type	Description	Intervention Names
Intervention	Experimental	EDP-322 v. Placebo	Drug: EDP-322

Name	Type	Description	Arm Group Labels	Other Names
EDP-322	Drug		Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The study objective was to determine the safety, tolerability and pharmacokinetics of multiple oral doses of EDP-322 in healthy volunteers.		Subjects received single doses of the study drug administered QD on Days 1 through 7, with follow-up through Day 11, and as needed.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adult males or females between 18 and 45 years of age
Females are eligible if documentation exists that they are surgically sterilized
In good general health [determined by medical history, physical examination, clinical laboratory tests, and without evidence of a clinically significant abnormality, in the opinion of the investigator and medical monitor.
Subject has a resting 12-lead ECG at screening that shows no clinically significant abnormality and a Bazett-corrected QT interval less than 450 milliseconds.
BMI between 18-32 kg/m2
Subject read, understood, and signed the ICF

Exclusion Criteria:

History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, CNS, hematologic or metabolic disease, or has an immunologic, emotional, and/or psychiatric disturbance.
History of gastric surgery, etc.
Abnormality or clinical lab test results at Screening that is considered clinical significant by the investigator or the medical monitor.
Gastroenteritis within 1 week before Day 1.
Acute illness that could pose a threat or harm to the subject or interfere with laboratory test results or interpretation of study data.
Donated blood within a 4 week period before Day 1.
Positive for Hep B, C or HIV-1, HIV=2, or positive results at Screening for hepatitis B surface antigen (HBsAG), HCV antibody, or HIV-1 or HIV-2 antibodies
Medication-related exclusions](streamdown:incomplete-link)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided