Clinical Trial: A Safety and PK Study of EC-18 in Healthy Subjects

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Administration of EC-18 in Healthy Subjec

Brief Summary: The purpose of this study is to determine if EC-18 is safe and tolerable in healthy subjects.

Detailed Summary: This will be a randomized, double-blind, placebo-controlled study of the safety, tolerability, PK, and pharmacodynamics of single ascending doses of EC-18 or placebo. If no dose limiting toxicity (DLT) is observed in Cohort One, the dose of EC-18 will be increased to in Cohorts Two, Three, and Four, respectively. Dose escalation to each successive cohort of subjects will not occur until a review of the safety and tolerability data from the previous cohort is completed and the Investigator, Sponsor, and study Medical Monitor together confirm the safety and tolerability of EC-18 given at that dose level.
Sponsor: Enzychem Lifesciences Corporation

Current Primary Outcome: The primary endpoint of the study will be the number and severity of treatment emergent adverse events (TEAEs) following single doses of EC-18 and placebo. [ Time Frame: 30 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To determine the composite pharmacokinetic (PK) parameters of EC-18 following sngle oral doses. AUC0-t, AUC0-24, Cmax, Tmax, 48-hour time period. [ Time Frame: Predose [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 hours post dose ]

AUC0-t: Area under the plasma drug concentration versus time curve from time zero to time t; AUC0-24: Area under the plasma concentration versus time curve from time zero to 24 hours after dosing, Cmax: Maximum observed plasma drug concentration; Tmax: Time of maximum drug concentration


Original Secondary Outcome: Same as current

Information By: Enzychem Lifesciences Corporation

Dates:
Date Received: June 29, 2015
Date Started: July 2015
Date Completion:
Last Updated: January 7, 2016
Last Verified: January 2016