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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00989872
Other study ID # EDP-322-007-001
Secondary ID
Status Completed
Phase Phase 1
First received October 5, 2009
Last updated October 5, 2009

Study information

Verified date October 2009
Source Enanta Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility 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...

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
EDP-322


Locations

Country Name City State
United States PPD Phase I Unit Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
Enanta Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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