NCT07023029

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteers
• Sickle Cell Disease
• Thalassemia

Interventions

Type	Name	Description
DRUG	Etavopivat	Etavopivat will be administered orally.
DRUG	Moxifloxacin	Moxifloxacin will be administered orally.
DRUG	Placebo	Placebo matching Etavopivat will be administered orally.

Timeline

• Start date: 2025-06-09
• Primary completion: 2025-09-12
• Completion: 2025-09-22
• First posted: 2025-06-15
• Last updated: 2026-01-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study