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
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 2, 2009
CompletedFirst Posted
Study publicly available on registry
March 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedNovember 2, 2010
September 1, 2010
3 months
March 2, 2009
November 1, 2010
Conditions
Outcome Measures
Primary Outcomes (2)
To determine the safety and tolerability of ABT-102 vs placebo in healthy adults.
10 days
To determine the plasma concentrations and pharmacokinetic parameters of multiple does of ABT-102 vs. placebo in healthy adults.
10 days
Secondary Outcomes (1)
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.
10 days
Study Arms (4)
1
ACTIVE COMPARATORABT-102 Tablets, 4 mg BID
2
ACTIVE COMPARATORABT-102 Tablets BID, escalating dose
3
ACTIVE COMPARATORABT-102 Tablets BID, escalating dose
4
PLACEBO COMPARATORPlacebo Tablets, BID
Interventions
Eligibility Criteria
You may qualify if:
- Males and Females with a condition of general good health.
- Must be willing to participate in all study-related procedures.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (1)
Site Reference ID/Investigator# 18101
Austin, Texas, 78744, United States
Related Publications (1)
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.
PMID: 21377273DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 2, 2009
First Posted
March 3, 2009
Study Start
March 1, 2009
Primary Completion
June 1, 2009
Last Updated
November 2, 2010
Record last verified: 2010-09