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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

March 2, 2009
November 1, 2010
March 2009
June 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00854659 on ClinicalTrials.gov Archive Site
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 ]
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: 7 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Safety, Tolerability and Pharmacokinetic Study of ABT-102 in Healthy Subjects
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study of the Safety, Tolerability and Pharmacokinetics of ABT-102 in Healthy Subjects

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy Volunteers
  • Drug: ABT-102
    BID tablets, 7 days of treatment
    Other Name: ABT-102
  • Drug: Placebo
    BID tablets, 7 days of treatment
    Other Name: Placebo
  • Active Comparator: 1
    ABT-102 Tablets, 4 mg BID
    Intervention: Drug: ABT-102
  • Active Comparator: 2
    ABT-102 Tablets BID, escalating dose
    Intervention: Drug: ABT-102
  • Active Comparator: 3
    ABT-102 Tablets BID, escalating dose
    Intervention: Drug: ABT-102
  • Placebo Comparator: 4
    Placebo Tablets, BID
    Intervention: Drug: Placebo
Rowbotham MC, Nothaft W, Duan WR, Wang Y, Faltynek C, McGaraughty S, Chu KL, Svensson P. Oral and cutaneous thermosensory profile of selective TRPV1 inhibition by ABT-102 in a randomized healthy volunteer trial. Pain. 2011 May;152(5):1192-200. doi: 10.1016/j.pain.2011.01.051. Epub 2011 Mar 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
Not Provided
June 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00854659
M10-613
No
Wolfram Nothaft, MD / Project Director, Abbott
Abbott
Not Provided
Not Provided
Abbott
September 2010

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