A Safety, Tolerability and Pharmacokinetic Study of ABT-102 in Healthy Subjects
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00854659
First received: March 2, 2009
Last updated: November 1, 2010
Last verified: September 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: ABT-102 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Further study details as provided by Abbott:
Primary Outcome Measures:
- To determine the safety and tolerability of ABT-102 vs placebo in healthy adults. [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
- To determine the plasma concentrations and pharmacokinetic parameters of multiple does of ABT-102 vs. placebo in healthy adults. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 36 |
| Study Start Date: | March 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
ABT-102 Tablets, 4 mg BID
|
Drug: ABT-102
BID tablets, 7 days of treatment
Other Name: ABT-102
|
|
Active Comparator: 2
ABT-102 Tablets BID, escalating dose
|
Drug: ABT-102
BID tablets, 7 days of treatment
Other Name: ABT-102
|
|
Active Comparator: 3
ABT-102 Tablets BID, escalating dose
|
Drug: ABT-102
BID tablets, 7 days of treatment
Other Name: ABT-102
|
|
Placebo Comparator: 4
Placebo Tablets, BID
|
Drug: Placebo
BID tablets, 7 days of treatment
Other Name: Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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 More Information
No publications provided by Abbott
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Wolfram Nothaft, MD / Project Director, Abbott |
| ClinicalTrials.gov Identifier: | NCT00854659 History of Changes |
| Other Study ID Numbers: | M10-613 |
| Study First Received: | March 2, 2009 |
| Last Updated: | November 1, 2010 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 23, 2013