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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000328-33 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-199 | Drug | Tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peng Lu, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 89694 | Clearwater | Florida | 33765 | United States | ||
| Site Reference ID/Investigator# 131720 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28691866 | Result | 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. | |
| 31541431 |
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| Other |
Tablet |
|
| 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 |
| DeBary |
| Florida |
| 32713 |
| United States |
| Site Reference ID/Investigator# 118637 | Miami | Florida | 33136 | United States |
| Site Reference ID/Investigator# 124116 | Miami Lakes | Florida | 33016 | United States |
| Site Reference ID/Investigator# 89693 | Orlando | Florida | 32806 | United States |
| Site Reference ID/Investigator# 78256 | Overland Park | Kansas | 66212 | United States |
| Site Reference ID/Investigator# 129826 | Rochester | Minnesota | 55905 | United States |
| Site Reference ID/Investigator# 89773 | Manhasset | New York | 11030 | United States |
| Site Reference ID/Investigator# 78254 | Duncansville | Pennsylvania | 16635 | United States |
| Site Reference ID/Investigator# 123335 | Dallas | Texas | 75231 | United States |
| Site Reference ID/Investigator# 78253 | Dallas | Texas | 75231 | United States |
| Site Reference ID/Investigator# 107896 | Berlin | 10117 | Germany |
| Site Reference ID/Investigator# 116395 | Distrito Federal | CP 14050 | Mexico |
| Site Reference ID/Investigator# 112555 | Monterrey | C.P. 64000 | Mexico |
| Site Reference ID/Investigator# 132009 | San Juan | 00909-3004 | Puerto Rico |
| 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. |
| 29333561 | Derived | 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. |
| ID | Term |
|---|---|
| C579720 | venetoclax |
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