A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Participants With Elevated Serum Lipoprotein(a)
Study Details
Study Description
Brief Summary
The main objective of this study is to evaluate the pharmacokinetics (PK) of a single dose of Olpasiran in Chinese participants with elevated serum lipoprotein(a) (Lp[a]).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Olpasiran Dose A Participants will be administered Olpasiran dose A as a subcutaneous injection. |
Drug: Olpasiran
Subcutaneous injection
Other Names:
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| Experimental: Olpasiran Dose B Participants will be administered Olpasiran dose B as a subcutaneous injection. |
Drug: Olpasiran
Subcutaneous injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Maximum Observed Concentration (Cmax) of Olpasiran [Day 1 to Day 4]
- Area Under the Concentration-time Curve (AUC) of Olpasiran [Day 1 to Day 4]
- Time to Maximum Observed Concentration (tmax) [Day 1 to Day 4]
- Hlaf-life (t1/2) of Olpasiran [Day 1 to Day 4]
- Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Olpasiran [Day 1 to Day 4]
- Apparent Total Body Clearance (CL/F) of Olpasiran [Day 1 to Day 4]
Secondary Outcome Measures
- Number of Participants with Treatment-emergent Adverse Events [Day 1 to Day 4]
- Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests [Baseline to Day 4]
- Number of Participants with a Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs) [Baseline to Day 4]
- Number of Participants with a Clinically Significant Change from Baseline in Vital Signs [Baseline to Day 4]
- Number of Participants with a Clinically Siginificant Change from Baseline in Lipid Levels [Baseline to Day 4]
- Number of Participants with a Clinically Significant Change from Baseline in Serum Lipoprotein(a) (LP[a]) [Baseline to Day 4]
Eligibility Criteria
Criteria
Inclusion Criteria:
Inclusion eligibility criteria will be evaluated in 2 parts during the screening period:
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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.
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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:
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Must be a resident in mainland China, Hong Kong, or Taiwan, and of Chinese Ancestry
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Male or female subjects, between 18 and 60 years of age (inclusive) at the time of Screening
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Screening serum Lp(a) ≥ 70 nmol/L (or approximately ≥ 27 mg/dL).
Part 2:
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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).
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Body mass index between 18 and 32 kg/m^2 (inclusive) at the time of Screening.
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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
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Females must be of non-reproductive potential:
- 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
- History of bilateral oophorectomy
Exclusion Criteria:
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History or clinical evidence of peripheral neuropathy
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Currently receiving apheresis as lipid reducing therapy
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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.
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History or clinical evidence of diabetes mellitus, including a fasting glucose ≥ 125 mg/dL (6.9 mmol/L) at Screening
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Queen Mary Hospital | Hong Kong | HK | Hong Kong |
Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20190095