A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-384 in Elderly Subjects

Abbott

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Matching placebo to ABT-384; Drug: ABT-384

Study type: Interventional

Funder types: Industry

Identifiers

NCT00968422

M10-506

Details and patient eligibility

About

The objectives of this study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ABT-384 in elderly subjects.

Enrollment: 28 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age is 65 years or greater
2. 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

1. Use of protocol-prohibited medications within 2 weeks prior to study drug administration.
2. Positive urine drug screen for non-prescribed drugs of abuse including alcohol.
3. Receipt of any drug depot by injection within 30 days prior to study drug administration.
4. Receipt of any investigational product within 6 weeks prior to study drug administration.
5. History of significant sensitivity or allergy to any drug.
6. History of drug or alcohol abuse within 2 years.
7. Positive test result for HBV, HCV or HIV.
8. Estimated creatinine clearance < 30 mL/min.
9. Donation or loss of 5 mL/kg or more blood volume or receipt of any blood product within 8 weeks prior to study drug administration.
10. Current enrollment in another clinical study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

28 participants in 4 patient groups, including a placebo group

Low dose ABT-384

Experimental group

Treatment:

Drug: ABT-384

Mid dose ABT-384

Experimental group

Treatment:

Drug: ABT-384

High dose ABT-384

Experimental group

Treatment:

Drug: ABT-384

Placebo

Placebo Comparator group

Treatment:

Drug: Matching placebo to ABT-384