NCT07023029CompletedPhase 1
A Study on the Effect of Etavopivat on Heart Rhythm in Healthy Participants
A Study to Assess the Effect of Etavopivat on Cardiac Repolarisation in Healthy Participants
Source: ClinicalTrials.gov · Last updated 2 Jan 2026
Brief summary (registry, in English)
Novo Nordisk is developing a new study medicine, Etavopivat, to treat individuals with sickle cell disease (SCD). The purpose of the study is to determine the effect of Etavopivat on the electrical activity of the heart in healthy participants. The study comprises two parts: Part A and Part B. Part A investigates the safety of a high dose of Etavopivat. In this phase, participants will receive either a single dose of Etavopivat or a placebo. Which treatment the participant gets is decided by chance. In Part B, participants will get four different treatments on four different occasions: Etavopivat in 2 different doses (the new medicine that cannot be prescribed), a dummy medicine (placebo), and an already approved medicine (moxifloxacin). The order of the 4 study medicines is decided by chance. There will be a break of 7 days between each treatment. For Part A, the study duration will be from 10 to 36 days, and for Part B, the study duration will be from 27 to 53 days.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 8 Jun 2025
- Start date
- 9 Jun 2025
- Primary completion date
- 12 Sept 2025
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Sickle cell disease, Thalassaemia
- NCT number
- NCT07023029
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 33
- From 9 Jun 2025 to the primary completion date, 12 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has used any product containing tobacco or nicotine within 90 days prior to 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.
Other illness
- Any condition which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
Lab values
- 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.
Other
- 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.
- Use of tobacco and nicotine products, defined as any of the below:
- Unable or unwilling to refrain from the use of any product containing tobacco or nicotine throughout the study.
- Positive nicotine test at screening.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PAREXEL Intl - EPCU-Baltimore Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.