Healthy Volunteers
Conditions
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.
Interventions
DRUGABT-102
BID tablets, 7 days of treatment
DRUGPlacebo
BID tablets, 7 days of treatment
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed