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

December 4, 2009
November 2, 2010
December 2009
February 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01050127 on ClinicalTrials.gov Archive Site
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A Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-436 in Healthy Adults
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The objectives of this study are to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of multiple doses of ABT-436 in healthy adults.

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Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy
  • Drug: ABT-436
    See Arm Description for details.
    Other Name: ABT-436
  • Drug: Placebo
    See Arm Description for details.
    Other Name: Placebo
  • Experimental: Low dose ABT-436
    ABT-436 or placebo administered once daily for 7 days.
    Interventions:
    • Drug: ABT-436
    • Drug: Placebo
  • Experimental: Mid Dose ABT-436
    ABT-436 or placebo administered once daily for 7 days.
    Interventions:
    • Drug: ABT-436
    • Drug: Placebo
  • Experimental: High Dose ABT-436
    ABT-436 or placebo administered once daily for 14 days.
    Interventions:
    • Drug: ABT-436
    • Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
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February 2010   (final data collection date for primary outcome measure)

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%.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01050127
M11-731
Not Provided
Katherine Tracy, MD, PhD, Abbott
Abbott
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Abbott
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP