Basic SciencePhase 1NCT06411860
A Study to Assess the Effect of Olpasiran on QT/QTc Intervals in Healthy Participants
A Phase 1 study testing Olpasiran and Moxifloxacin in people with Basic Science, run by Amgen at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Basic Science
- What is being tested?
- Olpasiran and Moxifloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Sep 2024to 11 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide informed consent prior to starting study activities.
- Healthy male or female participants, between 18 and 60 years of age (inclusive) at the time of Screening. Females must be of nonchildbearing potential.
- Body mass index between 18 and 30 kg/m^2 (inclusive) at the time of Screening. Participants must have a body mass ≥ 50kg.
Who cannot join
- History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
- History or current signs or symptoms of cardiovascular disease, including but not limited to myocardial infarction, congenital heart disease, valvular heart disease coronary revascularization, or angina.
- History or evidence of clinically significant arrhythmia at screening, including any clinically significant findings on the ECG taken at Check-in.
- Systolic blood pressure > 150 mmHg or < 90 mmHg, or diastolic blood pressure > 90 mmHg or < 50 mmHg, or HR ≤ 40 and > 100 bpm, at Screening or Check-in; one repeat blood pressure measurement will be allowed at Screening and Check-in.
- History suggestive of esophageal (including esophageal spasm, esophagitis), gastric, or duodenal ulceration or bowel disease (including but not limited to peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease, or irritable bowel syndrome), or a history of gastrointestinal surgery other than uncomplicated appendectomy and hernia repair.
- Inability to swallow oral medication or history of malabsorption syndrome.
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- History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
- History of major bleeding disorder (for example: hemophilia, von Willebrand disease, clotting factor deficiencies, etc).
- Participant has received a dose of an investigational drug within the past 90 days or have previously completed or withdrawn from this study or any other study investigating olpasiran or have previously received olpasiran.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Fortrea Clinical Research Unit Limited - Leeds
Leeds, LS11 9EH
About this study
Official title: A Randomized, Placebo- and Positive-controlled, Crossover Study to Assess the Effect of Olpasiran (AMG 890) on QT/QTc Intervals in Healthy Subjects
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.
- Conditions
- Basic Science
- Being tested
- Placebo, Olpasiran, Moxifloxacin
- Keywords
- QT/QTc Intervals, Healthy Participants, Olpasiran, AMG 890
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Participants will receive a subcutaneous (SC) injection of placebo.
OlpasiranDrug
Participants will receive a SC injection of olpasiran at dose level 1 or 2.
MoxifloxacinDrug
Participants will receive a single dose of moxifloxacin as an oral tablet by mouth.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Placebo |
| 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 Receives: Drug: Olpasiran |
| 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 Receives: Drug: Olpasiran |
| 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 Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-corrected Change From Baseline in QT Corrected for Heart Rate (HR) Interval Based on the Fridericia Correction (QTcF) (ΔΔQTcF) After Olpasiran Dosing
Measured: Day 3 of Treatment Period 4 (up to approximately 9.5 weeks)
Secondary outcomes (17)
Maximum Observed Concentration (Cmax) of Olpasiran
Measured: Up to 10 weeks
Time to Cmax (tmax) of Olpasiran
Measured: Up to 10 weeks
Half-life of Olpasiran (t1/2)
Measured: Up to 10 weeks
Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast)
Measured: Up to 10 weeks
Area Under the Curve From Time 0 to Infinity (AUCinf)
Measured: Up to 10 weeks
Change From Baseline in HR
Measured: Up to 10 weeks
Change From Baseline in QTcF
Measured: Up to 10 weeks
Change From Baseline in PR Interval
Measured: Up to 10 weeks
Change From Baseline in QRS Interval
Measured: Up to 10 weeks
Placebo-corrected Change From Baseline in HR
Measured: Up to 10 weeks
Placebo-corrected Change From Baseline in PR Interval
Measured: Up to 10 weeks
Placebo-corrected Change From Baseline in QRS Interval
Measured: Up to 10 weeks
Number of Participants with Categorical Outliers Related to the Following ECG parameter: QTcF, HR, PR, and QRS
Measured: Up to 10 weeks
Frequency of Treatment-emergent Changes in Electrocardiogram (ECG) Morphology
Measured: Up to 10 weeks
ΔΔQTcF After Moxifloxacin Dosing
Measured: Up to 10 weeks
Number of Participants With Treatment-emergent Adverse Events
Measured: Up to 10 weeks
Number of Participants With Treatment-emergent Serious Adverse Events
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start12 Sep 2024
- Primary completion29 Nov 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basic ScienceStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411860
- Sponsor's protocol ID
- 20220016
- Status last verified
- Oct 2026
- First submitted
- 29 Apr 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo- and Positive-controlled, Crossover Study to Assess the Effect of Olpasiran (AMG 890) on QT/QTc Intervals in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06411860
- Acronym / sponsor ID
- 20220016
- Conditions
- Basic Science
- Keywords
- QT/QTc Intervals, Healthy Participants, Olpasiran, AMG 890
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Placebo comparator | Other: PlaceboAll 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 B | Experimental | Drug: OlpasiranAll 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 | Drug: OlpasiranAll 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 | Drug: MoxifloxacinAll 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provide informed consent prior to starting study activities.
- Healthy male or female participants, between 18 and 60 years of age (inclusive) at the time of Screening. Females must be of nonchildbearing potential.
- Body mass index between 18 and 30 kg/m^2 (inclusive) at the time of Screening. Participants must have a body mass ≥ 50kg.
Key exclusion criteria (9 listed)
- History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
- History or current signs or symptoms of cardiovascular disease, including but not limited to myocardial infarction, congenital heart disease, valvular heart disease coronary revascularization, or angina.
- History or evidence of clinically significant arrhythmia at screening, including any clinically significant findings on the ECG taken at Check-in.
- Systolic blood pressure > 150 mmHg or < 90 mmHg, or diastolic blood pressure > 90 mmHg or < 50 mmHg, or HR ≤ 40 and > 100 bpm, at Screening or Check-in; one repeat blood pressure measurement will be allowed at Screening and Check-in.
- History suggestive of esophageal (including esophageal spasm, esophagitis), gastric, or duodenal ulceration or bowel disease (including but not limited to peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease, or irritable bowel syndrome), or a history of gastrointestinal surgery other than uncomplicated appendectomy and hernia repair.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboParticipants will receive a subcutaneous (SC) injection of placebo. | Other | Treatment A |
| OlpasiranParticipants will receive a SC injection of olpasiran at dose level 1 or 2. | Drug | Treatment B, Treatment C |
| MoxifloxacinParticipants will receive a single dose of moxifloxacin as an oral tablet by mouth. | Drug | Treatment D |
Primary outcome
Placebo-corrected Change From Baseline in QT Corrected for Heart Rate (HR) Interval Based on the Fridericia Correction (QTcF) (ΔΔQTcF) After Olpasiran Dosing
Time frame: Day 3 of Treatment Period 4 (up to approximately 9.5 weeks)
17 secondary outcomes
Maximum Observed Concentration (Cmax) of Olpasiran
Time frame: Up to 10 weeks
Time to Cmax (tmax) of Olpasiran
Time frame: Up to 10 weeks
Half-life of Olpasiran (t1/2)
Time frame: Up to 10 weeks
Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast)
Time frame: Up to 10 weeks
Area Under the Curve From Time 0 to Infinity (AUCinf)
Time frame: Up to 10 weeks
Change From Baseline in HR
Time frame: Up to 10 weeks
Change From Baseline in QTcF
Time frame: Up to 10 weeks
Change From Baseline in PR Interval
Time frame: Up to 10 weeks
Change From Baseline in QRS Interval
Time frame: Up to 10 weeks
Placebo-corrected Change From Baseline in HR
Time frame: Up to 10 weeks
Placebo-corrected Change From Baseline in PR Interval
Time frame: Up to 10 weeks
Placebo-corrected Change From Baseline in QRS Interval
Time frame: Up to 10 weeks
Number of Participants with Categorical Outliers Related to the Following ECG parameter: QTcF, HR, PR, and QRS
Time frame: Up to 10 weeks
Frequency of Treatment-emergent Changes in Electrocardiogram (ECG) Morphology
Time frame: Up to 10 weeks
ΔΔQTcF After Moxifloxacin Dosing
Time frame: Up to 10 weeks
Number of Participants With Treatment-emergent Adverse Events
Time frame: Up to 10 weeks
Number of Participants With Treatment-emergent Serious Adverse Events
Time frame: Up to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olpasiran and Moxifloxacin in people with Basic Science, run by Amgen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placebo-corrected Change From Baseline in QT Corrected for Heart Rate (HR) Interval Based on the Fridericia Correction (QTcF) (ΔΔQTcF) After Olpasiran Dosing (time frame: Day 3 of Treatment Period 4 (up to approximately 9.5 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.