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Completed

NCT Number: NCT06411860

A Study to Assess the Effect of Olpasiran on QT/QTc Intervals in Healthy Participants

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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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit Limited - Leeds

Leeds, LS11 9EH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Placebo

Other

Participants will receive a subcutaneous (SC) injection of placebo.

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Maximum Observed Concentration (Cmax) of Olpasiran

    Time frame: Up to 10 weeks

  2. Time to Cmax (tmax) of Olpasiran

    Time frame: Up to 10 weeks

  3. Half-life of Olpasiran (t1/2)

    Time frame: Up to 10 weeks

  4. Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast)

    Time frame: Up to 10 weeks

  5. Area Under the Curve From Time 0 to Infinity (AUCinf)

    Time frame: Up to 10 weeks

  6. Change From Baseline in HR

    Time frame: Up to 10 weeks

  7. Change From Baseline in QTcF

    Time frame: Up to 10 weeks

  8. Change From Baseline in PR Interval

    Time frame: Up to 10 weeks

  9. Change From Baseline in QRS Interval

    Time frame: Up to 10 weeks

  10. Placebo-corrected Change From Baseline in HR

    Time frame: Up to 10 weeks

  11. Placebo-corrected Change From Baseline in PR Interval

    Time frame: Up to 10 weeks

  12. Placebo-corrected Change From Baseline in QRS Interval

    Time frame: Up to 10 weeks

  13. Number of Participants with Categorical Outliers Related to the Following ECG parameter: QTcF, HR, PR, and QRS

    Time frame: Up to 10 weeks

  14. Frequency of Treatment-emergent Changes in Electrocardiogram (ECG) Morphology

    Time frame: Up to 10 weeks

  15. ΔΔQTcF After Moxifloxacin Dosing

    Time frame: Up to 10 weeks

  16. Number of Participants With Treatment-emergent Adverse Events

    Time frame: Up to 10 weeks

  17. Number of Participants With Treatment-emergent Serious Adverse Events

    Time frame: Up to 10 weeks

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Randomized, Placebo- and Positive-controlled, Crossover Study to Assess the Effect of Olpasiran (AMG 890) on QT/QTc Intervals in Healthy Subjects

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 13, 2024
Registry last updated
Oct 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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