To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with Systemic Lupus Erythematosus.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
97
Site Reference ID/Investigator# 89694
Clearwater, Florida, United States
Site Reference ID/Investigator# 131720
DeBary, Florida, United States
Number of participants with Adverse Events
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
Physical Exam including vital signs
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
Clinical Lab Testing
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
Electrocardiogram (ECG) Measurements
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
Maximum observed serum concentration (Cmax) of ABT-199
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
Time to Cmax (Tmax) of ABT-199
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
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
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
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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, United States
Site Reference ID/Investigator# 89773
Manhasset, New York, United States
Site Reference ID/Investigator# 78254
Duncansville, Pennsylvania, United States
Site Reference ID/Investigator# 123335
Dallas, Texas, United States
...and 5 more locations
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
Time frame: For 72 hours after a single dose of ABT-199
Measurement of lymphocyte depletion and recovery
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