Pharmacokinetic Study of ABT-126 in Healthy Volunteers

Abbott

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ABT-126; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00959634

M11-988

Details and patient eligibility

About

This is a study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and eliminated by the body of a healthy volunteer.

Enrollment: 20 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female subjects between 18 and 50 years of age
• If female, subject must be postmenopausal for at least 2 years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
• If male, subject must be surgically sterile (vasectomy) or agrees to use a barrier method (i.e., condom) of birth control starting on the first day of confinement until 30 days after the last study drug administration

Exclusion criteria

• Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements on a regular basis
• History of diabetes, cancer (except basal cell carcinoma of the skin), or any clinically significant cardiovascular, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, neurologic or psychiatric disease or disorder
• Presence of any uncontrolled medical illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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20 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Dose 1 BID

Treatment:

Drug: ABT-126

2

Experimental group

Description:

Dose 2 BID

Treatment:

Drug: ABT-126

3

Placebo Comparator group

Description:

Placebo BID

Treatment:

Drug: Placebo