A Safety, Tolerability and Pharmacokinetic Study of ABT-102 in Healthy Subjects
NCT ID: NCT00854659
Last Updated: 2010-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
ABT-102 Tablets, 4 mg BID
ABT-102
BID tablets, 7 days of treatment
2
ABT-102 Tablets BID, escalating dose
ABT-102
BID tablets, 7 days of treatment
3
ABT-102 Tablets BID, escalating dose
ABT-102
BID tablets, 7 days of treatment
4
Placebo Tablets, BID
Placebo
BID tablets, 7 days of treatment
Interventions
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ABT-102
BID tablets, 7 days of treatment
Placebo
BID tablets, 7 days of treatment
Eligibility Criteria
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Inclusion Criteria
* Must be willing to participate in all study-related procedures.
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Locations
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Site Reference ID/Investigator# 18101
Austin, Texas, United States
Countries
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References
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Rowbotham MC, Nothaft W, Duan RW, 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):1192-1200. doi: 10.1016/j.pain.2011.01.051. Epub 2011 Mar 4.
Other Identifiers
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M10-613
Identifier Type: -
Identifier Source: org_study_id