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A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)

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ClinicalTrials.gov Identifier: NCT01686555
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Tracking Information
First Submitted Date  ICMJE September 13, 2012
First Posted Date  ICMJE September 18, 2012
Last Update Posted Date November 20, 2017
Study Start Date  ICMJE November 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2012)
  • Number of participants with Adverse Events [ Time Frame: From first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199 ]
    Collect all adverse events at each visit
  • Physical Exam including vital signs [ Time Frame: Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199 ]
    Blood pressure, heart rate and body temperature
  • Clinical Lab Testing [ Time Frame: Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199 ]
    Hematology, Chemistry, and Urinalysis
  • Electrocardiogram (ECG) Measurements [ Time Frame: For 24 hours after a single dose of ABT-199 and up to 24 hours after the seventh dose of multiple doses of ABT-199 ]
    ECGs done in triplicate
  • Maximum observed serum concentration (Cmax) of ABT-199 [ Time Frame: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199 ]
    Cmax
  • Time to Cmax (Tmax) of ABT-199 [ Time Frame: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199 ]
    Time to Cmax
  • The area under the time curve (AUC) of ABT-199 [ Time Frame: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199 ]
    the area under the exposure-time curve of ABT-199 extrapolated to infinite time for single doses and up to 24 hrs for multiple doses of ABT-199
  • The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-199 [ Time Frame: For 72 hours after a single dose of ABT-199 ]
    The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-199
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2012)
  • Number of participants with Adverse Events [ Time Frame: From first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199 ]
    Collect all adverse events at each visit
  • Physical Exam including vital signs [ Time Frame: Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199 ]
    Blood pressure, heart rate and body temperature
  • Clinical Lab Testing [ Time Frame: Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199 ]
    Hematology, Chemistry, and Urinalysis
  • Electrocardiogram (ECG) Measurements [ Time Frame: For 24 hours after a single dose of ABT-199 and up to 24 hours after the seventh dose of multiple doses of ABT-199 ]
    ECGs done in triplicate
  • Maximum observed serum concentration (Cmax) of ABT-199 [ Time Frame: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199 ]
    Cmax
  • Time to Cmax (Tmax) of ABT-199 [ Time Frame: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199 ]
    Time to Cmax
  • The area under the time curve (AUC) of ABT-199 [ Time Frame: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199 ]
    the area under the exposure-time curve of ABT-199 extrapolated to infinite time for single doses and up to 24 hrs for multiple doses of ABT-199
  • The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-199 [ Time Frame: For 72 hours after a single dose of ABT-199 and for 72 hours after the seventh dose of multiple doses of ABT-199 ]
    The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-199
Change History Complete list of historical versions of study NCT01686555 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2012)
Measurement of lymphocyte depletion and recovery [ Time Frame: Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199 ]
explore pharmacokinetic/pharmacodynamic relationship
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)
Official Title  ICMJE Assessment of the Safety, Tolerability, and Pharmacokinetics of ABT-199 After Single and Multiple Ascending Doses in Female Subjects With Systemic Lupus Erythematosus (SLE)
Brief Summary To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with Systemic Lupus Erythematosus.
Detailed Description This is a phase 1, randomized, double-blind, placebo-controlled, single-and multiple ascending dose study. Up to eighty-eight subjects with Systemic Lupus Erythematosus will be selected to participate. Subjects will be randomized to receive either ABT-199 or placebo. Subjects will be administered ABT-199/placebo as a single dose or up to 14 days as multiple doses.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Lupus Erythematosus
Intervention  ICMJE
  • Drug: ABT-199
    Tablet
  • Other: Placebo
    Tablet
Study Arms  ICMJE
  • Experimental: Single Dose
    Subjects enrolled in the Single Ascending Dose (SAD) part of the study will receive a single dose of study drug or placebo. (Groups 1, 2, 3, 4, 5 and 6).
    Interventions:
    • Drug: ABT-199
    • Other: Placebo
  • Experimental: Multiple Dose
    Subjects enrolled in the Multiple Ascending Dose (MAD) part of the study will receive multiple doses of study drug or placebo. (Groups 7, 8, 9, 10 and 11)
    Interventions:
    • Drug: ABT-199
    • Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2015)
97
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2012)
88
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of systemic lupus erythematosus for at least 6 months.
  • Documentation of at least one of the following: ANA titer >= 1:160 or positive anti-dsDNA antibodies.
  • Stable systemic lupus erythematosus medication regimen.
  • Other than systemic lupus erythematosus, subject should be in general good health.

Exclusion Criteria:

  • Male.
  • Drug-induced or highly active systemic lupus erythematosus.
  • Significant autoimmune disease other than lupus.
  • Significant, uncontrolled or unstable disease in any organ.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Mexico,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01686555
Other Study ID Numbers  ICMJE M13-093
2013-000328-33 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbbVie ( AbbVie (prior sponsor, Abbott) )
Study Sponsor  ICMJE AbbVie (prior sponsor, Abbott)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Peng Lu, MD AbbVie
PRS Account AbbVie
Verification Date July 2015

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