drugset / Trial / NCT01686555
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)
RandomizedParallel-groupTriple-blindTreatment
Summary
To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with Systemic Lupus Erythematosus.
Timeline
- Start
- 2012-11
- Primary completion
- 2015-06
- Completion
- 2015-06
Publications
- Results 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Venetoclax | Small molecule | 10 mg | Oral |
| Subject | Venetoclax | Small molecule | 30 mg | Oral |
| Subject | Venetoclax | Small molecule | 60 mg | Oral |
| Subject | Venetoclax | Small molecule | 90 mg | Oral |
| Subject | Venetoclax | Small molecule | 120 mg | Oral |
| Subject | Venetoclax | Small molecule | 180 mg | Oral |
| Subject | Venetoclax | Small molecule | 240 mg | Oral |
| Subject | Venetoclax | Small molecule | 300 mg | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |
| Subject | Venetoclax | Small molecule | 500 mg | Oral |
| Subject | Venetoclax | Small molecule | 600 mg | Oral |