drugset / Trial / NCT01342211
A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.
Timeline
- Start
- 2011-07
- Primary completion
- 2012-02
- Completion
- 2012-06
Publications
- Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.
- Wan H, Gumbiner B, Joh T, Riel T, Udata C, Forgues P, Garzone PD. Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition with Bococizumab on Lipoprotein Particles in Hypercholesterolemic Subjects. Clin Ther. 2017 Nov;39(11):2243-2259.e5. doi: 10.1016/j.clinthera.2017.09.009. Epub 2017 Oct 14.
- Udata C, Garzone PD, Gumbiner B, Joh T, Liang H, Liao KH, Williams JH, Meng X. A Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Bococizumab, a Humanized Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, and Its Application in Early Clinical Development. J Clin Pharmacol. 2017 Jul;57(7):855-864. doi: 10.1002/jcph.867. Epub 2017 Feb 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bococizumab | Monoclonal antibody | 10 mg/ml | Intravenous |
| Background | Atorvastatin | Small molecule | 40 mg | — |
| Background | Atorvastatin | Small molecule | 80 mg | — |
| Background | Rosuvastatin | Small molecule | 20 mg | — |
| Background | Rosuvastatin | Small molecule | 40 mg | — |
| Background | Simvastatin | Small molecule | 40 mg | — |
| Background | Simvastatin | Small molecule | 80 mg | — |