NCT07626281 · Novartis Pharmaceuticals
Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation
What this study is about
The purpose of this study is to compare safety, tolerability, how the drug moves through the body (PK), and how the drug affects the body (PD) of the currently marketed formulation of inclisiran with a new formulation containing polysorbate 80 (PS80), after a single 284 mg injected under the skin (SC) administration.
View original scientific description
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.
Interventions
DRUG
Inclisiran formulation containing PS80
Inclisiran 284 mg
DRUG
Currently marketed inclisiran formulation
Inclisiran 284 mg
Primary outcome measures
Primary plasma PK parameters: Cmax
Time frame: Day 1, Day 2, Day 3 and Day 4
Cmax = maximum observed plasma concentration
Primary plasma PK parameters: AUClast
Time frame: Day 1, Day 2, Day 3 and Day 4
AUClast = AUC from time zero to the last measurable concentration sampling time
Primary plasma PK parameters: AUCinf
Time frame: Day 1, Day 2, Day 3 and Day 4
AUCinf = AUC from time zero to infinity
Additional PK parameters: AUC0-24hr
Time frame: Day 1, Day 2, Day 3 and Day 4
AUC0-24hr = AUC from time zero to 24 hours
Additional PK parameters: Tmax
Time frame: Day 1, Day 2, Day 3 and Day 4
Tmax = time to reach maximum plasma concentration
Additional PK parameters: T1/2
Time frame: Day 1, Day 2, Day 3 and Day 4
T1/2 = elimination half-life
Additional PK parameters: CL/F
Time frame: Day 1, Day 2, Day 3 and Day 4
CL/F = total body clearance
Additional PK parameters: Vz/F
Time frame: Day 1, Day 2, Day 3 and Day 4
Vz/F = apparent volume of distribution
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 participants must be statin naive), other oral LDL-C-lowering medication or supplements that in investigators' judgment may affect serum LDL-C levels. Other protocol inclusion/exclusion criteria may apply
Where
- Lenexa, Kansas
- San Antonio, Texas
- Salt Lake City, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations