A Study on the Effect of Etavopivat on Heart Rhythm in Healthy Participants

Launched by NOVO NORDISK A/S · Jun 8, 2025

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ClinConnect Summary

This clinical trial is studying a new medicine called Etavopivat, which is being developed to help treat sickle cell disease. However, in this study, the researchers want to see how Etavopivat affects heart rhythm in healthy volunteers. The trial has two parts: the first part will test the safety of a single high dose of the medicine compared to a placebo (a dummy treatment that has no effect), while the second part will involve participants receiving four different treatments on separate occasions, including two doses of Etavopivat, a placebo, and another approved medicine called moxifloxacin.

To be eligible for this study, participants should be healthy adults aged 18 to 55, with a body weight over 40 kg and a specific body mass index (BMI). Women who are pregnant or breastfeeding cannot participate, and those with certain heart conditions or who use tobacco products are also excluded. Participants can expect to be involved in the study for about 10 to 53 days, depending on which part they are in, and they will have regular check-ups to monitor their health throughout. The study aims to include a diverse group of participants, particularly ensuring representation from African-American volunteers and a balanced number of men and women.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female.
• • Aged 18-55 years (both inclusive) at the time of signing informed consent.
• • Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m\^2) (both inclusive) at screening.
• • Body weight above 40.0 kg at screening.
• • Considered to be generally healthy based on the medical history, physical examination and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
• Exclusion Criteria:
• • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods, as defined in Appendix 4, Section 10.4.
• • Current participation (i.e., signed informed consent) in any other interventional clinical study.
• • Exposure to an investigational medicinal product within 30 days or 5 half-lives of the investigational medicinal product (IMP) (if known), whichever is longer, before screening.
• • Any condition which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
• • Second or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds (ms)., or of the corrected QT interval using the Fredericia formula (QTcF) over 450 ms for males and 470 ms for females, prominent U waves, or any other clinically significant abnormal ECG results or changes that make ECGs unsuitable for QT evaluations as judged by the investigator, at screening.
• * Use of tobacco and nicotine products, defined as any of the below:
• • Has used any product containing tobacco or nicotine within 90 days prior to screening.
• • Unable or unwilling to refrain from the use of any product containing tobacco or nicotine throughout the study.
• • Positive nicotine test at screening.
• • Participant is unable to refrain from or anticipates the use of antacids, iron, or any drug known to be a moderate or strong inhibitor or inducer of uridine 5'-diphosphoglucuronosyltransferase (UGT) enzymes, cytochrome P450 (CYP) 3A4, CYP2C9 or permeability glycoprotein (P-gp), including St. John's Wort, for 28 days prior to dosing and throughout the study (Section 6.8).
• • Participant is unable to refrain from or anticipate the use of any medications or substances prohibited in the study (Sections 5.3, 5.5 and 6.8).
• • A minimum of 20% African-American participants will be included in each part of this study.
• • Efforts will be made to include at least 40 percentage (%) of each sex into each part of the study.