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

November 16, 2017 updated by: AbbVie (prior sponsor, Abbott)

Assessment of the Safety, Tolerability, and Pharmacokinetics of ABT-199 After Single and Multiple Ascending Doses in Female Subjects With Systemic Lupus Erythematosus (SLE)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

97

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Berlin, Germany, 10117
        • Site Reference ID/Investigator# 107896
      • Distrito Federal, Mexico, CP 14050
        • Site Reference ID/Investigator# 116395
      • Monterrey, Mexico, C.P. 64000
        • Site Reference ID/Investigator# 112555
      • San Juan, Puerto Rico, 00909-3004
        • Site Reference ID/Investigator# 132009
    • Florida
      • Clearwater, Florida, United States, 33765
        • Site Reference ID/Investigator# 89694
      • DeBary, Florida, United States, 32713
        • Site Reference ID/Investigator# 131720
      • Miami, Florida, United States, 33136
        • Site Reference ID/Investigator# 118637
      • Miami Lakes, Florida, United States, 33016
        • Site Reference ID/Investigator# 124116
      • Orlando, Florida, United States, 32806
        • Site Reference ID/Investigator# 89693
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Site Reference ID/Investigator# 78256
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Site Reference ID/Investigator# 129826
    • New York
      • Manhasset, New York, United States, 11030
        • Site Reference ID/Investigator# 89773
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Site Reference ID/Investigator# 78254
    • Texas
      • Dallas, Texas, United States, 75231
        • Site Reference ID/Investigator# 123335
      • Dallas, Texas, United States, 75231
        • Site Reference ID/Investigator# 78253

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Tablet
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)
Tablet
Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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
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 (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
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 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
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 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
For 72 hours after a single dose of ABT-199

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Peng Lu, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 13, 2012

First Submitted That Met QC Criteria

September 13, 2012

First Posted (Estimate)

September 18, 2012

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

July 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • M13-093
  • 2013-000328-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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