Status:

COMPLETED

A Safety, Tolerability and Pharmacokinetic Study of ABT-102 in Healthy Subjects

Lead Sponsor:

Abbott

Conditions:

Healthy Volunteers

Eligibility:

All Genders

18-55 years

Phase:

PHASE1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of three different strengths of an investigational product dosed twice a day over 7 days in healthy subjects.

Eligibility Criteria

Inclusion

  • Males and Females with a condition of general good health.
  • Must be willing to participate in all study-related procedures.

Exclusion

  • History of significant sensitivity to any drug.
  • Allergy to soy lecithin, soybeans, soybean oil, or other soybean derivatives.
  • A requirement for medications, vitamins and/or herbal supplements during the study.
  • Pregnant or breast-feeding.
  • History of drug or alcohol abuse.
  • Positive Hepatitis or HIV test.
  • History of certain medical conditions or any uncontrolled medical illness.
  • History of certain gastrointestinal surgeries that may interfere with gastrointestinal motility, PH or absorption.
  • Current participation in another clinical study or receipt of investigational drug within the past 6 weeks.

Key Trial Info

Start Date :

March 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT00854659

Start Date

March 1 2009

Last Update

November 2 2010

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Site Reference ID/Investigator# 18101

Austin, Texas, United States, 78744