Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Par… (NCT04774003) | Clinical Trial Compass
CompletedPhase 1
Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Participants With Elevated Serum LDL-C
China40 participantsStarted 2021-02-26
Plain-language summary
Study to evaluate the pharmacokinetics and pharmacodynamics of inclisiran treatment given as single subcutaneous injection in Chinese participants with elevated low-density lipoprotein cholesterol (LDL-C) despite treatment with LDL-C lowering therapies
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Written informed consent must be obtained before any assessment is performed.
✓. Male or female participants ≥ 18 years of age at screening
✓. Participants should meet fasting serum LDL-C ≥ 100 mg/dL (≥ 2.6 mmol/L) at screening
✓. Participants should meet fasting triglyceride \< 400 mg/dL (\< 4.52 mmol/L) at screening
✓. Participants should be receiving a maximally tolerated dose of statin#.
✓. For all participants, all the lipid-lowering therapy/ies (such as but not limited to statins and/or ezetimibe) should have remained stable (stable dose and no medication change) for ≥ 30 days before screening with no planned medication or dose change during study participation. #Maximum tolerated dose was defined as the maximum dose of statin that could be taken on a regular basis without intolerable AEs.
✓. Participants not receiving statin must have a documented evidence of intolerance to all doses of at least 2 different statins (or the corresponding local definition of complete intolerance to statins)
Exclusion criteria
✕. Participants diagnosed with any of following: homozygous familial hypercholesterolemia, New York Heart Association class III \& IV heart failure, Type 2 diabetes, severe hypertension, active liver disease, HIV infection or any uncontrolled or serious disease;
✕. History of drug abuse or unhealthy alcohol use, malignancy of any organ system, or or allergy to the investigational compound/compound class;
What they're measuring
1
PK parameters (Cmax) maximum peak observed plasma inclisiran concentration in treated participants
Timeframe: 0-48 hours post-dose
2
PK parameters (Tmax) time to reach maximum peak plasma inclisiran concentration in treated participants
Timeframe: 0-48 hours post-dose
3
PK parameters (T1/2) the elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve in inclisiran treated participants
Timeframe: 0-48 hours post-dose
4
PK parameters (AUC) area under the plasma concentration-time curve in inclisiran treated participants
Timeframe: 0-48 hours post-dose
5
Percentage change in Proprotein convertase subtilisin kexin 9 (PCSK9) from baseline overtime
Timeframe: Baseline to Days 5, 8, 15, 30, 60 and 90
6
Percentage change in Low density lipoprotein cholesterol (LDL-C) from baseline overtime
Timeframe: Baseline to Days 5, 8, 15, 30, 60 and 90
. Major adverse cardiovascular event within 3 months prior to randomization;
✕. Calculated glomerular filtration rate ≤30 mL/min by estimated glomerular filtration rate (eGFR) using standardized clinical methodology;
✕. Use of other investigational drugs or planned use of other investigational products or devices;
✕. Women of child-bearing potential unless they are using basic methods of contraception during dosing of investigational drug (total abstinence, sterilization, barrier methods, hormonal contraception, intrauterine device);
✕. Treatment with monoclonal antibodies inhibiting PCSK9 within 90 days prior to screening.