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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00854659
First received: March 2, 2009
Last updated: November 1, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: ABT-102
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study of the Safety, Tolerability and Pharmacokinetics of ABT-102 in Healthy Subjects

Further study details as provided by Abbott:

Primary Outcome Measures:
  • To determine the safety and tolerability of ABT-102 vs placebo in healthy adults. [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
  • To determine the plasma concentrations and pharmacokinetic parameters of multiple does of ABT-102 vs. placebo in healthy adults. [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exploratory analyses of Quantitive Thermosensory Testing (Warm Detection Threshold, Cold Detection Threshold, Warm Pain Threshold) done at peripheral and oral sites, will be done for ABT-102 and placebo treated subjects. [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: March 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
ABT-102 Tablets, 4 mg BID
Drug: ABT-102
BID tablets, 7 days of treatment
Other Name: ABT-102
Active Comparator: 2
ABT-102 Tablets BID, escalating dose
Drug: ABT-102
BID tablets, 7 days of treatment
Other Name: ABT-102
Active Comparator: 3
ABT-102 Tablets BID, escalating dose
Drug: ABT-102
BID tablets, 7 days of treatment
Other Name: ABT-102
Placebo Comparator: 4
Placebo Tablets, BID
Drug: Placebo
BID tablets, 7 days of treatment
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00854659

Locations
United States, Texas
Site Reference ID/Investigator# 18101
Austin, Texas, United States, 78744
Sponsors and Collaborators
Abbott
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wolfram Nothaft, MD / Project Director, Abbott
ClinicalTrials.gov Identifier: NCT00854659     History of Changes
Other Study ID Numbers: M10-613
Study First Received: March 2, 2009
Last Updated: November 1, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 15, 2014