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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01686555
First received: September 13, 2012
Last updated: July 7, 2015
Last verified: July 2015
  Purpose

To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with Systemic Lupus Erythematosus.


Condition Intervention Phase
Lupus Erythematosus
Drug: ABT-199
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of the Safety, Tolerability, and Pharmacokinetics of ABT-199 After Single and Multiple Ascending Doses in Female Subjects With Systemic Lupus Erythematosus (SLE)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-199


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    explore pharmacokinetic/pharmacodynamic relationship


Enrollment: 97
Study Start Date: November 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Drug: ABT-199
Tablet
Other: Placebo
Tablet
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)
Drug: ABT-199
Tablet
Other: Placebo
Tablet

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686555

Locations
United States, Florida
Site Reference ID/Investigator# 89694
Clearwater, Florida, United States, 33765
Site Reference ID/Investigator# 131720
Debary, Florida, United States, 32713
Site Reference ID/Investigator# 118637
Miami, Florida, United States, 33136
Site Reference ID/Investigator# 124116
Miami Lakes, Florida, United States, 33016
Site Reference ID/Investigator# 89693
Orlando, Florida, United States, 32806
United States, Kansas
Site Reference ID/Investigator# 78256
Overland Park, Kansas, United States, 66212
United States, Minnesota
Site Reference ID/Investigator# 129826
Rochester, Minnesota, United States, 55905
United States, New York
Site Reference ID/Investigator# 89773
Manhasset, New York, United States, 11030
United States, Pennsylvania
Site Reference ID/Investigator# 78254
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Site Reference ID/Investigator# 123335
Dallas, Texas, United States, 75231
Site Reference ID/Investigator# 78253
Dallas, Texas, United States, 75231
Germany
Site Reference ID/Investigator# 107896
Berlin, Germany, 10117
Mexico
Site Reference ID/Investigator# 116395
Distrito Federal, Mexico, CP 14050
Site Reference ID/Investigator# 112555
Monterrey, Mexico, C.P. 64000
Puerto Rico
Site Reference ID/Investigator# 132009
San Juan, Puerto Rico, 00909-3004
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Peng Lu, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01686555     History of Changes
Other Study ID Numbers: M13-093, 2013-000328-33
Study First Received: September 13, 2012
Last Updated: July 7, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2015