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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01050127
First received: December 4, 2009
Last updated: November 2, 2010
Last verified: September 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: ABT-436
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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) [ Time Frame: Days -2 through Day 7 or 14 ] [ Designated as safety issue: Yes ]
  • Assess Pharmacokinetics (i.e., ABT-436 and possible metabolite levels) [ Time Frame: Day -1 through Day 7 ] [ Designated as safety issue: No ]
  • Pharmacodynamics (i.e., biomarkers of drug effect) [ Time Frame: Day -1 through Day 7 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: December 2009
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose ABT-436
ABT-436 or placebo administered once daily for 7 days.
 Drug: ABT-436
See Arm Description for details.
Other Name: ABT-436
Drug: Placebo
See Arm Description for details.
Other Name: Placebo
Experimental: Mid Dose ABT-436
ABT-436 or placebo administered once daily for 7 days.
 Drug: ABT-436
See Arm Description for details.
Other Name: ABT-436
Drug: Placebo
See Arm Description for details.
Other Name: Placebo
Experimental: High Dose ABT-436
ABT-436 or placebo administered once daily for 14 days.
 Drug: ABT-436
See Arm Description for details.
Other Name: ABT-436
Drug: Placebo
See Arm Description for details.
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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%.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050127

Locations
United States, Illinois
Site Reference ID/Investigator# 24849
Waukegan, Illinois, United States, 60085
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Katherine Tracy, MD, PhD, Abbott
ClinicalTrials.gov Identifier: NCT01050127     History of Changes
Other Study ID Numbers: M11-731
Study First Received: December 4, 2009
Last Updated: November 2, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Pharmacokinetics
Pharmacodynamics
Drug Safety
Phase 1 Clinical Trial

ClinicalTrials.gov processed this record on May 19, 2013