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

Lupus Erythematosus Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686555
• Other study ID #: M13-093
• Secondary ID: 2013-000328-33
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2012
• Last updated: November 16, 2017
• Start date: November 2012
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus
• Lupus Erythematosus, Systemic

Intervention

Drug:
• ABT-199
Tablet

Other:
• Placebo
Tablet

Locations

Country	Name	City	State
Germany	Site Reference ID/Investigator# 107896	Berlin
Mexico	Site Reference ID/Investigator# 116395	Distrito Federal
Mexico	Site Reference ID/Investigator# 112555	Monterrey
Puerto Rico	Site Reference ID/Investigator# 132009	San Juan
United States	Site Reference ID/Investigator# 89694	Clearwater	Florida
United States	Site Reference ID/Investigator# 123335	Dallas	Texas
United States	Site Reference ID/Investigator# 78253	Dallas	Texas
United States	Site Reference ID/Investigator# 131720	DeBary	Florida
United States	Site Reference ID/Investigator# 78254	Duncansville	Pennsylvania
United States	Site Reference ID/Investigator# 89773	Manhasset	New York
United States	Site Reference ID/Investigator# 118637	Miami	Florida
United States	Site Reference ID/Investigator# 124116	Miami Lakes	Florida
United States	Site Reference ID/Investigator# 89693	Orlando	Florida
United States	Site Reference ID/Investigator# 78256	Overland Park	Kansas
United States	Site Reference ID/Investigator# 129826	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

United States,  Germany,  Mexico,  Puerto Rico, 

References & Publications (1)

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 system — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Measurement of lymphocyte depletion and recovery	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