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Recruiting NCT07626281

Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation

Phase I Interventional Inclisiran Formulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inclisiran formulation containing PS80, Currently marketed inclisiran formulation.
Who it may be relevant to
Registry conditions: Inclisiran Formulation. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed 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 treatment period of 90 days.

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]
  • Primary plasma PK parameters: AUClast [Time frame: Day 1, Day 2, Day 3 and Day 4]
  • Primary plasma PK parameters: AUCinf [Time frame: Day 1, Day 2, Day 3 and Day 4]
  • Additional PK parameters: AUC0-24hr [Time frame: Day 1, Day 2, Day 3 and Day 4]
  • Additional PK parameters: Tmax [Time frame: Day 1, Day 2, Day 3 and Day 4]
  • Additional PK parameters: T1/2 [Time frame: Day 1, Day 2, Day 3 and Day 4]
  • Additional PK parameters: CL/F [Time frame: Day 1, Day 2, Day 3 and Day 4]
  • Additional PK parameters: Vz/F [Time frame: Day 1, Day 2, Day 3 and Day 4]
Secondary outcome measures (1)
  • Number of participants with AEs [Time frame: Up to Day 90]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Lenexa Research Unit — Lenexa
  • Cardiovasular Renal Metabolism — San Antonio
  • Salt Lake City Research Unit — Salt Lake City

Identifiers

NCT: NCT07626281 · CKJX839A12107

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗