A Safety, Tolerability and Pharmacokinetic Study of ABT-102 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: ABT-102; Drug: Placebo

• Registration Number: NCT00854659
• Lead Sponsor: Abbott

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-02
• Study First Submitted QC: 2009-03-02
• Study First Posted: 2009-03-03
• Primary Completion: 2009-06
• Status Verified: 2010-09
• Last Update Submitted: 2010-11-01
• Last Update Posted: 2010-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ABT-102	ABT-102 Tablets, 4 mg BID
2	ABT-102	ABT-102 Tablets BID, escalating dose
3	ABT-102	ABT-102 Tablets BID, escalating dose
4	Placebo	Placebo Tablets, BID

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Site Reference ID/Investigator# 18101; 🇺🇸 Austin, Texas, United States