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The primary objective of the study is:
• To assess the effects of a single therapeutic and supratherapeutic dose of olpasiran on the placebo-corrected change from baseline in QT corrected for heart rate (ΔΔQT)/QTc interval in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Placebo Comparator | All participants will be randomized to 1 of 12 treatment sequences and receive a single dose of one of the following treatments, according to the randomization schedule: Treatment A: placebo Treatment B: dose level 1 olpasiran Treatment C: dose level 2 olpasiran Treatment D: moxifloxacin |
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| Treatment B | Experimental | All participants will be randomized to 1 of 12 treatment sequences and receive a single dose of one of the following treatments, according to the randomization schedule: Treatment A: placebo Treatment B: dose level 1 olpasiran Treatment C: dose level 2 olpasiran Treatment D: moxifloxacin |
|
| Treatment C | Experimental | All participants will be randomized to 1 of 12 treatment sequences and receive a single dose of one of the following treatments, according to the randomization schedule: Treatment A: placebo Treatment B: dose level 1 olpasiran Treatment C: dose level 2 olpasiran Treatment D: moxifloxacin |
|
| Treatment D | Active Comparator | All participants will be randomized to 1 of 12 treatment sequences and receive a single dose of one of the following treatments, according to the randomization schedule: Treatment A: placebo Treatment B: dose level 1 olpasiran Treatment C: dose level 2 olpasiran Treatment D: moxifloxacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Participants will receive a subcutaneous (SC) injection of placebo. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-corrected Change From Baseline in QT Corrected for Heart Rate (HR) Interval Based on the Fridericia Correction (QTcF) (ΔΔQTcF) After Olpasiran Dosing | Day 3 of Treatment Period 4 (up to approximately 9.5 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Olpasiran | Up to 10 weeks | |
| Time to Cmax (tmax) of Olpasiran | Up to 10 weeks | |
| Half-life of Olpasiran (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit Limited - Leeds | Leeds | LS11 9EH | United Kingdom |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
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| ID | Term |
|---|---|
| C000723009 | olpasiran |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Olpasiran |
| Drug |
Participants will receive a SC injection of olpasiran at dose level 1 or 2. |
|
| Moxifloxacin | Drug | Participants will receive a single dose of moxifloxacin as an oral tablet by mouth. |
|
| Up to 10 weeks |
| Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast) | Up to 10 weeks |
| Area Under the Curve From Time 0 to Infinity (AUCinf) | Up to 10 weeks |
| Change From Baseline in HR | Up to 10 weeks |
| Change From Baseline in QTcF | Up to 10 weeks |
| Change From Baseline in PR Interval | Up to 10 weeks |
| Change From Baseline in QRS Interval | Up to 10 weeks |
| Placebo-corrected Change From Baseline in HR | Up to 10 weeks |
| Placebo-corrected Change From Baseline in PR Interval | Up to 10 weeks |
| Placebo-corrected Change From Baseline in QRS Interval | Up to 10 weeks |
| Number of Participants with Categorical Outliers Related to the Following ECG parameter: QTcF, HR, PR, and QRS | Up to 10 weeks |
| Frequency of Treatment-emergent Changes in Electrocardiogram (ECG) Morphology | Up to 10 weeks |
| ΔΔQTcF After Moxifloxacin Dosing | Up to 10 weeks |
| Number of Participants With Treatment-emergent Adverse Events | Up to 10 weeks |
| Number of Participants With Treatment-emergent Serious Adverse Events | Up to 10 weeks |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |