Safety of AT-1001 in Healthy Volunteers
To demonstrate the safety and tolerance of multiple, oral doses of AT-1001
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||A Phase 1, Randomized, Double-Blind, Placebo Controlled, Multi-Dose Study to Determine the Safety, Tolerance and Pharmacokinetics of 3 Dose Levels of AT-1001 in Healthy Volunteers|
- To demonstrate the safety and tolerance of multiple, oral doses of AT-1001
- To determine whether quantifiable AT-1001 concentrations are present in plasma following oral drug administration and to characterize the pharmacokinetic behavior of AT-1001
- Pharmacokinetic Measures
|Study Start Date:||January 2006|
|Estimated Study Completion Date:||February 2006|
Subjects will complete screening and thereafter be admitted to the clinic prior to treatment. Three (3) cohorts of 8 (3:1 ratio drug to placebo) subjects will receive 250 µg, 1 mg, or 4 mg of AT-1001 or matching placebo three times a day for 10 days. The subjects will be evaluated for safety at screening, prior to administration of treatment, and following dosing of the study drug. Serial blood samples will be collected for pharmacokinetic determinations at baseline and 2 hours post morning dose on Days 1, 2, 5, 6 and 10. Blood pressure, pulse, temperature and monitoring for adverse events will occur prior to the morning dose on all other study days. An end of study visit will occur 7-10 days after last dose.
Subjects will be evaluated at screening (medical history, physical examination, vital signs, clinical laboratory testing, and 12-lead electrocardiograms). A physical exam, vital signs, clinical laboratory testing and an EKG will be conducted pre first dose. Vital signs, clinical laboratory testing and EKGs will be monitored post dose. Adverse event reports will be monitored throughout the study. At the end of the study a physical exam, clinical laboratory testing and an EKG will be performed.