NCT01686555

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2012

Typical duration for phase_1

Geographic Reach
4 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 20, 2017

Status Verified

July 1, 2015

Enrollment Period

2.6 years

First QC Date

September 13, 2012

Last Update Submit

November 16, 2017

Conditions

Lupus Erythematosus

Outcome Measures

Primary Outcomes (8)

  • Number of participants with Adverse Events

    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

    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

    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

    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

    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 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

    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

    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 Outcomes (1)

  • Measurement of lymphocyte depletion and recovery

    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

Study Arms (2)

Single Dose

EXPERIMENTAL

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-199Other: Placebo

Multiple Dose

EXPERIMENTAL

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-199Other: Placebo

Interventions

ABT-199DRUG

Tablet

Multiple DoseSingle Dose
PlaceboOTHER

Tablet

Multiple DoseSingle Dose

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Male.
  • Drug-induced or highly active systemic lupus erythematosus.
  • Significant autoimmune disease other than lupus.
  • Significant, uncontrolled or unstable disease in any organ.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Site Reference ID/Investigator# 89694

Clearwater, Florida, 33765, United States

Location

Site Reference ID/Investigator# 131720

DeBary, Florida, 32713, United States

Location

Site Reference ID/Investigator# 118637

Miami, Florida, 33136, United States

Location

Site Reference ID/Investigator# 124116

Miami Lakes, Florida, 33016, United States

Location

Site Reference ID/Investigator# 89693

Orlando, Florida, 32806, United States

Location

Site Reference ID/Investigator# 78256

Overland Park, Kansas, 66212, United States

Location

Site Reference ID/Investigator# 129826

Rochester, Minnesota, 55905, United States

Location

Site Reference ID/Investigator# 89773

Manhasset, New York, 11030, United States

Location

Site Reference ID/Investigator# 78254

Duncansville, Pennsylvania, 16635, United States

Location

Site Reference ID/Investigator# 123335

Dallas, Texas, 75231, United States

Location

Site Reference ID/Investigator# 78253

Dallas, Texas, 75231, United States

Location

Site Reference ID/Investigator# 107896

Berlin, 10117, Germany

Location

Site Reference ID/Investigator# 116395

Distrito Federal, CP 14050, Mexico

Location

Site Reference ID/Investigator# 112555

Monterrey, C.P. 64000, Mexico

Location

Site Reference ID/Investigator# 132009

San Juan, 00909-3004, Puerto Rico

Location

Related Publications (3)

  • 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.

    PMID: 28691866RESULT

  • 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.

    PMID: 31541431DERIVED

  • 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.

    PMID: 29333561DERIVED

MeSH Terms

Interventions

venetoclax

Study Officials

  • Peng Lu, MD

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2012

First Posted

September 18, 2012

Study Start

November 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 20, 2017

Record last verified: 2015-07

Locations

PR(1)US(11)ME(2)DE(1)