- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04987320
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Participants With Elevated Serum Lipoprotein(a)
An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Subjects With Elevated Serum Lipoprotein(a)
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
HK
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Hong Kong, HK, Hong Kong
- Queen Mary Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Inclusion eligibility criteria will be evaluated in 2 parts during the screening period:
- Part 1: After written informed consent is obtained, subjects will provide a blood sample for a preliminary Lp(a) assessment to determine eligibility for Part 2 screening. Subjects with Lp(a) ≥ 70 nmol/L (or approximately ≥ 27 mg/dL) will be eligible to return to the CRU Part 2 screening. Subjects not eligible to return for Part 2 screening will be screen failed.
- Part 2: Eligible subjects will complete all remaining screening procedures and tests that establish eligibility within 40 days prior to the Day 1 visit.
Part 1:
- Must be a resident in mainland China, Hong Kong, or Taiwan, and of Chinese Ancestry
- Male or female subjects, between 18 and 60 years of age (inclusive) at the time of Screening
- Screening serum Lp(a) ≥ 70 nmol/L (or approximately ≥ 27 mg/dL).
Part 2:
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) as assessed by the Investigator (or designee).
- Body mass index between 18 and 32 kg/m^2 (inclusive) at the time of Screening.
- Subjects who are on statin must be on a stable dose of the same statin for at least 6 weeks prior to enrollment, and plan to remain on a stable dose (i.e., no change in medication or dosage) for the duration of the study
Females must be of non-reproductive potential:
a. Postmenopausal defined as: i. Age of ≥ 55 years with no menses for at least 12 months; OR ii. Age of < 55 years with no menses for at least 12 months AND with a follicle stimulating hormone (FSH) level > 40 IU/L or according to the definition of "postmenopausal range" for the laboratory involved; OR b. History of hysterectomy; OR c. History of bilateral oophorectomy
Exclusion Criteria:
- History or clinical evidence of peripheral neuropathy
- Currently receiving apheresis as lipid reducing therapy
- History or clinical evidence of bleeding diathesis or any coagulation disorder, including prothrombin time (PT), activated partial thromboplastin time (APTT), or platelet count outside of the laboratory's normal reference range at screening. Subjects with PT and/or APTT values that are outside of the laboratory's normal reference range at screening may still be eligible to proceed to enrollment if the results are judged by the investigator in consultation with the study medical monitor to not be clinically significant.
- History or clinical evidence of diabetes mellitus, including a fasting glucose ≥ 125 mg/dL (6.9 mmol/L) at Screening
- Use of any herbal medicines, vitamins or dietary supplements known to affect lipid metabolism (e.g. sigh oils > 100mg/day, red yeast extract), within 30 days prior to dosing on Day 1 and for the duration of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Olpasiran Dose A
Participants will be administered Olpasiran dose A as a subcutaneous injection.
|
Subcutaneous injection
Other Names:
|
Experimental: Olpasiran Dose B
Participants will be administered Olpasiran dose B as a subcutaneous injection.
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Subcutaneous injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Observed Concentration (Cmax) of Olpasiran
Time Frame: Day 1 to Day 85
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Day 1 to Day 85
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Area Under the Concentration-time Curve (AUC) of Olpasiran
Time Frame: Day 1 to Day 85
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Day 1 to Day 85
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Time to Maximum Observed Concentration (tmax)
Time Frame: Day 1 to Day 85
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Day 1 to Day 85
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Half-life (t1/2) of Olpasiran
Time Frame: Day 1 to Day 85
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Day 1 to Day 85
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Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Olpasiran
Time Frame: Day 1 to Day 85
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Day 1 to Day 85
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Apparent Total Body Clearance (CL/F) of Olpasiran
Time Frame: Day 1 to Day 85
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Day 1 to Day 85
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with Treatment-emergent Adverse Events
Time Frame: Day 1 to Day 225
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Day 1 to Day 225
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Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests
Time Frame: Day 1 to Day 225
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Day 1 to Day 225
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Number of Participants with a Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs)
Time Frame: Day 1 to Day 225
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Day 1 to Day 225
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Number of Participants with a Clinically Significant Change from Baseline in Vital Signs
Time Frame: Day 1 to Day 225
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Day 1 to Day 225
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Number of Participants with a Clinically Siginificant Change from Baseline in Lipid Levels
Time Frame: Day 1 to Day 225
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Day 1 to Day 225
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Number of Participants with a Clinically Significant Change from Baseline in Serum Lipoprotein(a) (LP[a])
Time Frame: Day 1 to Day 225
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Day 1 to Day 225
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: MD, Amgen
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20190095
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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