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

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00854659
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: ABT-102; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study of the Safety, Tolerability and Pharmacokinetics of ABT-102 in Healthy Subjects
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Jun 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. To determine the safety and tolerability of ABT-102 vs placebo in healthy adults. [10 days]

2. To determine the plasma concentrations and pharmacokinetic parameters of multiple does of ABT-102 vs. placebo in healthy adults. [10 days]

Secondary Outcome Measures

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. [10 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 18101	Austin	Texas	United States	78744

Sponsors and Collaborators

• Abbott

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00854659
• Other Study ID Numbers: M10-613
• First Posted: Mar 3, 2009
• Last Update Posted: Nov 2, 2010
• Last Verified: Sep 1, 2010

Study Results

No Results Posted as of Nov 2, 2010