NCT00854659
Completed
Phase 1
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study of the Safety, Tolerability and Pharmacokinetics of ABT-102 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- ABT-102
- Conditions
- Healthy Volunteers
- Sponsor
- Abbott
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- To determine the safety and tolerability of ABT-102 vs placebo in healthy adults.
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
1
ABT-102 Tablets, 4 mg BID
Intervention: ABT-102
2
ABT-102 Tablets BID, escalating dose
Intervention: ABT-102
3
ABT-102 Tablets BID, escalating dose
Intervention: ABT-102
4
Placebo Tablets, BID
Intervention: Placebo
Outcomes
Primary Outcomes
To determine the safety and tolerability of ABT-102 vs placebo in healthy adults.
Time Frame: 10 days
To determine the plasma concentrations and pharmacokinetic parameters of multiple does of ABT-102 vs. placebo in healthy adults.
Time Frame: 10 days
Secondary Outcomes
- 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 Sites (1)
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