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

Abbott

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: ABT-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT00854659

M10-613

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

ABT-102 Tablets, 4 mg BID

Treatment:

Drug: ABT-102

2

Active Comparator group

Description:

ABT-102 Tablets BID, escalating dose

Treatment:

Drug: ABT-102

3

Active Comparator group

Description:

ABT-102 Tablets BID, escalating dose

Treatment:

Drug: ABT-102

4

Placebo Comparator group

Description:

Placebo Tablets, BID

Treatment:

Drug: Placebo