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

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01009216
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 13
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: ABT-384	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study to Evaluate the Cerebrospinal Fluid Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-384 in Healthy Male Volunteers
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABT-384	Drug: ABT-384; Doses will be administered daily for 5 days.

Outcome Measures

Primary Outcome Measures

1. Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations) [Days -1 through 9]

2. Assess Pharmacokinetics (i.e., ABT-384 and possible metabolite levels) and Pharmacodynamics (i.e., biomarkers of drug effect) [Days 1, 4 through 9]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 23882	Glendale	California	United States	91206

Sponsors and Collaborators

• Abbott

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01009216
• Other Study ID Numbers: M10-505
• First Posted: Nov 6, 2009
• Last Update Posted: Dec 14, 2010
• Last Verified: Nov 1, 2010

• Keywords provided by , ,: Pharmacokinetics; Pharmacology; Drug Safety; Phase 1 Clinical Trials

Study Results

No Results Posted as of Dec 14, 2010