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Safety of AT-1001 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Alba Therapeutics
ClinicalTrials.gov Identifier:
NCT00386490
First received: October 9, 2006
Last updated: October 10, 2006
Last verified: October 2006

October 9, 2006
October 10, 2006
January 2006
Not Provided
  • 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
Same as current
Complete list of historical versions of study NCT00386490 on ClinicalTrials.gov Archive Site
Pharmacokinetic Measures
Same as current
Not Provided
Not Provided
 
Safety of AT-1001 in Healthy Volunteers
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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Healthy
Drug: AT-1001
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
February 2006
Not Provided

Inclusion Criteria:

  • Subject must be in generally good health and free of any clinical disease that may interfere with study evaluations.
  • BMI between 18 and 30.

Exclusion Criteria:

  • Subject has been using chronic medications within 30 days prior to treatment (excluding hormonal contraceptives)
  • Subject has taken any medications within 14 days prior to treatment (excluding hormonal contraceptives, additional exceptions at the discretion of the Sponsor).
  • Subject has consumed significant quantities of alcohol (> 3 fl oz. ETOH) within 2 days of treatment visit.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00386490
CLIN1001-003
Not Provided
Not Provided
Alba Therapeutics
Not Provided
Study Chair: Blake Paterson, MD Alba Therapeutics
Alba Therapeutics
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP