A Study of ABT-384 Levels and Pharmacodynamic Activity Measured in Cerebrospinal Fluid

Abbott

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ABT-384

Study type: Interventional

Funder types: Industry

Identifiers

NCT01009216

M10-505

Details and patient eligibility

About

The objectives of this study are to assess the cerebral spinal fluid (CSF) pharmacokinetics and the plasma/CSF pharmacokinetic/pharmacodynamic relationship of ABT-384 in healthy male volunteers.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age is between 18 and 55 years
• Judged to be in a condition of general good health based on the results of medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG

Exclusion criteria

• Use of protocol-prohibited medications within 2 weeks prior to study drug administration.
• Positive urine drug screen for non-prescribed drugs of abuse including alcohol.
• Receipt of any drug depot by injection within 30 days prior to study drug administration.
• Receipt of any investigational product within 6 weeks prior to study drug administration.
• History of significant sensitivity or allergy to any drug.
• History of drug or alcohol abuse.
• Positive test result for HAV, HBsAg, HCV or HIV.
• Donation or loss of 550 mL or more blood volume or receipt of any blood product within 3 months prior to study drug administration.
• Contraindication for lumbar puncture (e.g., lumbar scoliosis, coagulopathy, infected skin at puncture site)
• Current enrollment in another clinical study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

ABT-384

Experimental group

Treatment:

Drug: ABT-384