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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ABT-102; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • Site Reference ID/Investigator# 18101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; ABT-102 Tablets, 4 mg BID	Drug: ABT-102; BID tablets, 7 days of treatment
Active Comparator: 2; ABT-102 Tablets BID, escalating dose	Drug: ABT-102; BID tablets, 7 days of treatment
Active Comparator: 3; ABT-102 Tablets BID, escalating dose	Drug: ABT-102; BID tablets, 7 days of treatment
Placebo Comparator: 4; Placebo Tablets, BID	Drug: Placebo; BID tablets, 7 days of treatment

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Abbott

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: March 2, 2009
• First Submitted That Met QC Criteria: March 2, 2009
• First Posted (Estimate): March 3, 2009

Study Record Updates

• Last Update Posted (Estimate): November 2, 2010
• Last Update Submitted That Met QC Criteria: November 1, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: M10-613