A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)
- Registration Number
- NCT01686555
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 97
- 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.
- Male.
- Drug-induced or highly active systemic lupus erythematosus.
- Significant autoimmune disease other than lupus.
- Significant, uncontrolled or unstable disease in any organ.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single Dose Placebo 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). Multiple Dose Placebo 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) Single Dose ABT-199 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). Multiple Dose ABT-199 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)
- Primary Outcome Measures
Name Time Method Number of participants with Adverse Events 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
Physical Exam including vital signs 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
Clinical Lab Testing 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
Maximum observed serum concentration (Cmax) 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 Cmax
Electrocardiogram (ECG) Measurements 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
Time to Cmax (Tmax) 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 Time to Cmax
The area under the time curve (AUC) 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 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 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
- Secondary Outcome Measures
Name Time Method 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 explore pharmacokinetic/pharmacodynamic relationship
Trial Locations
- Locations (15)
Site Reference ID/Investigator# 89694
🇺🇸Clearwater, Florida, United States
Site Reference ID/Investigator# 124116
🇺🇸Miami Lakes, Florida, United States
Site Reference ID/Investigator# 78256
🇺🇸Overland Park, Kansas, United States
Site Reference ID/Investigator# 89773
🇺🇸Manhasset, New York, United States
Site Reference ID/Investigator# 116395
🇲🇽Distrito Federal, Mexico
Site Reference ID/Investigator# 78254
🇺🇸Duncansville, Pennsylvania, 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# 107896
🇩🇪Berlin, Germany
Site Reference ID/Investigator# 112555
🇲🇽Monterrey, Mexico
Site Reference ID/Investigator# 118637
🇺🇸Miami, Florida, United States
Site Reference ID/Investigator# 129826
🇺🇸Rochester, Minnesota, United States
Site Reference ID/Investigator# 89693
🇺🇸Orlando, Florida, United States
Site Reference ID/Investigator# 132009
🇵🇷San Juan, Puerto Rico