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Completed

NCT Number: NCT00854659

A Safety, Tolerability and Pharmacokinetic Study 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 18101

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABT-102

Drug

BID tablets, 7 days of treatment

Placebo

Drug

BID tablets, 7 days of treatment

Primary outcomes

  1. To determine the safety and tolerability of ABT-102 vs placebo in healthy adults.

    Time frame: 10 days

  2. 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

  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.

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study of the Safety, Tolerability and Pharmacokinetics of ABT-102 in Healthy Subjects

Important dates

Study start
2009
Primary completion
2009
First posted
Mar 3, 2009
Registry last updated
Nov 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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