Trial record 9 of 85 for:    Lupus AND (woman OR women OR female)

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01686555
First received: September 13, 2012
Last updated: July 22, 2014
Last verified: July 2014
  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


Estimated Enrollment: 88
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Contacts
Contact: Imran Ghiasuddin 847-935-5704 imran.ghiasuddin@abbvie.com
Contact: Christa Lee, BS 847-938-5855 christa.lee@abbvie.com

Locations
United States, Florida
Site Reference ID/Investigator# 89694 Recruiting
Clearwater, Florida, United States, 33765
Principal Investigator: Site Reference ID/Investigator# 89694         
Site Reference ID/Investigator# 118637 Recruiting
Miami, Florida, United States, 33144
Principal Investigator: Site Reference ID/Investigator# 118637         
Site Reference ID/Investigator# 89693 Recruiting
Orlando, Florida, United States, 32806
Principal Investigator: Site Reference ID/Investigator# 89693         
United States, Kansas
Site Reference ID/Investigator# 78256 Recruiting
Overland Park, Kansas, United States, 66212
Principal Investigator: Site Reference ID/Investigator# 78256         
United States, New York
Site Reference ID/Investigator# 89773 Recruiting
Manhasset, New York, United States, 11030
Principal Investigator: Site Reference ID/Investigator# 89773         
United States, Pennsylvania
Site Reference ID/Investigator# 78254 Recruiting
Duncansville, Pennsylvania, United States, 16635
Principal Investigator: Site Reference ID/Investigator# 78254         
United States, Texas
Site Reference ID/Investigator# 78253 Recruiting
Dallas, Texas, United States, 75231
Principal Investigator: Site Reference ID/Investigator# 78253         
Germany
Site Reference ID/Investigator# 107896 Recruiting
Berlin, Germany, 10117
Principal Investigator: Site Reference ID/Investigator# 107896         
Mexico
Site Reference ID/Investigator# 116395 Not yet recruiting
Distrito Federal, Mexico, CP 14050
Principal Investigator: Site Reference ID/Investigator# 116395         
Site Reference ID/Investigator# 112555 Recruiting
Monterrey, Mexico, C.P. 64000
Principal Investigator: Site Reference ID/Investigator# 112555         
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 22, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 26, 2014