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

NCT00990145 | Completed Phase 1

• 1 other identifier: EDP-322-07-002
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

MRSA, SSTI

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Intervention

EXPERIMENTAL

EDP-322 v. Placebo

Drug: EDP-322

Interventions

EDP-322 DRUG

Intervention

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (1)

PPD Phase I Unit

Austin, Texas, United States

Location

Study Design

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

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 6, 2009
• Study Start: November 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 8, 2009

Record last verified: 2009-10

Locations

US (1)