Lupus Erythematosus
Conditions
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.
Interventions
DRUGABT-199
Tablet
OTHERPlacebo
Tablet
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany, Mexico, Puerto Rico, United States
Outcome results
None listed