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

Primary Purpose

Lupus Erythematosus

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABT-199
Placebo
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Site Reference ID/Investigator# 89694
  • Site Reference ID/Investigator# 131720
  • Site Reference ID/Investigator# 124116
  • Site Reference ID/Investigator# 118637
  • Site Reference ID/Investigator# 89693
  • Site Reference ID/Investigator# 78256
  • Site Reference ID/Investigator# 129826
  • Site Reference ID/Investigator# 89773
  • Site Reference ID/Investigator# 78254
  • Site Reference ID/Investigator# 123335
  • Site Reference ID/Investigator# 78253
  • Site Reference ID/Investigator# 107896
  • Site Reference ID/Investigator# 116395
  • Site Reference ID/Investigator# 112555
  • Site Reference ID/Investigator# 132009

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Single Dose

Multiple Dose

Arm Description

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).

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)

Outcomes

Primary Outcome Measures

Number of participants with Adverse Events
Collect all adverse events at each visit
Physical Exam including vital signs
Blood pressure, heart rate and body temperature
Clinical Lab Testing
Hematology, Chemistry, and Urinalysis
Electrocardiogram (ECG) Measurements
ECGs done in triplicate
Maximum observed serum concentration (Cmax) of ABT-199
Cmax
Time to Cmax (Tmax) of ABT-199
Time to Cmax
The area under the time curve (AUC) 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
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
explore pharmacokinetic/pharmacodynamic relationship

Full Information

First Posted
September 13, 2012
Last Updated
November 16, 2017
Sponsor
AbbVie (prior sponsor, Abbott)
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1. Study Identification

Unique Protocol Identification Number
NCT01686555
Brief Title
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Dose
Arm Type
Experimental
Arm Description
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).
Arm Title
Multiple Dose
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
ABT-199
Intervention Description
Tablet
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
Number of participants with Adverse Events
Description
Collect all adverse events at each visit
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
Title
Physical Exam including vital signs
Description
Blood pressure, heart rate and body temperature
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
Title
Clinical Lab Testing
Description
Hematology, Chemistry, and Urinalysis
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
Title
Electrocardiogram (ECG) Measurements
Description
ECGs done in triplicate
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
Title
Maximum observed serum concentration (Cmax) of ABT-199
Description
Cmax
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
Title
Time to Cmax (Tmax) of ABT-199
Description
Time to Cmax
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
Title
The area under the time curve (AUC) of ABT-199
Description
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
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
Title
The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-199
Description
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
Secondary Outcome Measure Information:
Title
Measurement of lymphocyte depletion and recovery
Description
explore pharmacokinetic/pharmacodynamic relationship
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peng Lu, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 89694
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Site Reference ID/Investigator# 131720
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
Site Reference ID/Investigator# 124116
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Site Reference ID/Investigator# 118637
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Site Reference ID/Investigator# 89693
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site Reference ID/Investigator# 78256
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Site Reference ID/Investigator# 129826
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Site Reference ID/Investigator# 89773
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Site Reference ID/Investigator# 78254
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Site Reference ID/Investigator# 123335
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Site Reference ID/Investigator# 78253
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Site Reference ID/Investigator# 107896
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Site Reference ID/Investigator# 116395
City
Distrito Federal
ZIP/Postal Code
CP 14050
Country
Mexico
Facility Name
Site Reference ID/Investigator# 112555
City
Monterrey
ZIP/Postal Code
C.P. 64000
Country
Mexico
Facility Name
Site Reference ID/Investigator# 132009
City
San Juan
ZIP/Postal Code
00909-3004
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
28691866
Citation
Lu P, Fleischmann R, Curtis C, Ignatenko S, Clarke SH, Desai M, Wong SL, Grebe KM, Black K, Zeng J, Stolzenbach J, Medema JK. Safety and pharmacodynamics of venetoclax (ABT-199) in a randomized single and multiple ascending dose study in women with systemic lupus erythematosus. Lupus. 2018 Feb;27(2):290-302. doi: 10.1177/0961203317719334. Epub 2017 Jul 10.
Results Reference
result
PubMed Identifier
31541431
Citation
Nader A, Minocha M, Othman AA. Exposure-Response Analyses of the Effects of Venetoclax, a Selective BCL-2 Inhibitor, on B-Lymphocyte and Total Lymphocyte Counts in Women with Systemic Lupus Erythematosus. Clin Pharmacokinet. 2020 Mar;59(3):335-347. doi: 10.1007/s40262-019-00818-5.
Results Reference
derived
PubMed Identifier
29333561
Citation
Minocha M, Zeng J, Medema JK, Othman AA. Pharmacokinetics of the B-Cell Lymphoma 2 (Bcl-2) Inhibitor Venetoclax in Female Subjects with Systemic Lupus Erythematosus. Clin Pharmacokinet. 2018 Sep;57(9):1185-1198. doi: 10.1007/s40262-017-0625-2.
Results Reference
derived

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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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