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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014