A Randomized, Open-label, Single-dose, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Inclisiran Containing Polysorbate 80 Versus Inclisiran Alone in Participants With Elevated Low-density Lipoprotein Cholesterol
Novartis Pharmaceuticals
Summary
The purpose of this study is to compare safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the currently marketed formulation of inclisiran with a new formulation containing polysorbate 80 (PS80), after a single 284 mg subcutaneous (SC) administration.
Description
This is a randomized, single-dose, open-label, parallel-group, study to evaluate the PK, safety, and tolerability of inclisiran 284 mg. The study drug will be administered as a single SC injection to the abdomen administered as 2 different formulations (the marketed formulation and a test formulation containing PS80). Approximately 152 adult participants (76 per formulation) with elevated serum LDL-C, but otherwise healthy, are planned to be enrolled. The duration of the study for each participant will be approximately 118 days including the screening, up to 28 days, baseline period, and trea…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Healthy male and female (non-childbearing potential) participants between 18 and 60 years of age (inclusive) with fasting serum LDL-C between 100 and 189 mg/dL (2.6 to 4.89 mmol/L) and fasting triglyceride \<400 mg/dL (\<4.52 mmol/L) that are not on statin or any other lipid lowering therapy. * Body mass index (BMI) between 18 and 35 kg/m2, inclusive, at screening with a body weight of at least 50 kg. Exclusion Criteria: * Participants with homozygous and heterozygous familial hypercholesterolemia will be excluded. * Historical or current use of any statin (i.e. study…
Interventions
- DrugInclisiran formulation containing PS80
Inclisiran 284 mg
- DrugCurrently marketed inclisiran formulation
Inclisiran 284 mg
Locations (3)
- Lenexa Research UnitLenexa, Kansas
- Cardiovasular Renal MetabolismSan Antonio, Texas
- Salt Lake City Research UnitSalt Lake City, Utah