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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00854659
• Other study ID #: M10-613
• Status: Completed
• Phase: Phase 1
• First received: March 2, 2009
• Last updated: November 1, 2010
• Start date: March 2009

Study information

• Verified date: September 2010
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ABT-102
BID tablets, 7 days of treatment
• Placebo
BID tablets, 7 days of treatment

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 18101	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety and tolerability of ABT-102 vs placebo in healthy adults.		10 days	Yes
Primary	To determine the plasma concentrations and pharmacokinetic parameters of multiple does of ABT-102 vs. placebo in healthy adults.		10 days	No
Secondary	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	No