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
  Purpose

To demonstrate the safety and tolerance of multiple, oral doses of AT-1001


Condition Intervention Phase
Healthy
Drug: AT-1001
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Further study details as provided by Alba Therapeutics:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Pharmacokinetic Measures

Estimated Enrollment: 24
Study Start Date: January 2006
Estimated Study Completion Date: February 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386490

Locations
United States, Maryland
Parexel
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Alba Therapeutics
Investigators
Study Chair: Blake Paterson, MD Alba Therapeutics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00386490     History of Changes
Other Study ID Numbers: CLIN1001-003
Study First Received: October 9, 2006
Last Updated: October 10, 2006
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 23, 2014