A Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-436 in Healthy Adults

The objectives of this study are to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of multiple doses of ABT-436 in healthy adults.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ABT-436; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Waukegan, Illinois, United States, 60085
      • Site Reference ID/Investigator# 24849

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age is between 18 and 55 years, inclusive.
2. If female, subject must be postmenopausal for at least two years or surgically sterile.
3. Females must have negative results for pregnancy tests prior to study drug administration.
4. If male, subject must be surgically sterile or agree to be sexually inactive or agree to use a barrier method of birth control.
5. Body Mass Index is 18.0 to 29.9 kg/m2 (2 = superscript number), inclusive.
6. A condition of general good health based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram.
7. Must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

Exclusion Criteria:

1. History of significant sensitivity or allergy to any drug.
2. Use of known inhibitors or inducers of CYP3A within 30 days prior to the first dose of study drug and through the end of the study.
3. Requirement for, or use of within the 2-week period prior to study drug administration, any over-the-counter or prescription medication, vitamins, minerals or herbal supplements on a regular basis.
4. Receipt of any depot drug by injection within 30 days prior to study drug administration.
5. Positive screen for drugs of abuse or alcohol, or recent (6-month) history of drug or alcohol abuse.
6. Use of tobacco or other nicotine-containing products within the six-month period preceding study drug administration.
7. Donation or loss of 550 mL of blood or more (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to the first dose of study drug.
8. Receipt of an investigational product within a time period equal to 10 half-lives, if known, or a minimum of 6 weeks prior to study drug administration.
9. Has a clinically significant abnormal diastolic blood pressure (< 45 or > 90 mm Hg), systolic blood pressure (< 85 or > 140 mm Hg) or heart rate (< 45 or > 100 bpm).
10. HbA1c > 6.0%.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose ABT-436; ABT-436 or placebo administered once daily for 7 days.	Drug: ABT-436; See Arm Description for details.; Drug: Placebo; See Arm Description for details.
Experimental: Mid Dose ABT-436; ABT-436 or placebo administered once daily for 7 days.	Drug: ABT-436; See Arm Description for details.; Drug: Placebo; See Arm Description for details.
Experimental: High Dose ABT-436; ABT-436 or placebo administered once daily for 14 days.	Drug: ABT-436; See Arm Description for details.; Drug: Placebo; See Arm Description for details.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and Tolerability Assessments (i.e., electrocardiogram(ECG), clinical laboratory tests, vital signs, weight, adverse events (AE) assessment, pulmonary function tests, physical and brief neurological examinations)	Days -2 through Day 7 or 14
Assess Pharmacokinetics (i.e., ABT-436 and possible metabolite levels)	Day -1 through Day 7
Pharmacodynamics (i.e., biomarkers of drug effect)	Day -1 through Day 7

Collaborators and Investigators

• Sponsor: Abbott

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: December 4, 2009
• First Submitted That Met QC Criteria: January 13, 2010
• First Posted (Estimate): January 15, 2010

Study Record Updates

• Last Update Posted (Estimate): November 3, 2010
• Last Update Submitted That Met QC Criteria: November 2, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Pharmacodynamics; Drug Safety; Phase 1 Clinical Trial
• Other Study ID Numbers: M11-731