NCT06581627

A Research Study Looking at a Single Dose of Etavopivat in Healthy Chinese Participants

A Single-centre, Open-label, Single-group Study Investigating the Pharmacokinetics, Safety and Tolerability After a Single Dose of Oral Etavopivat in Healthy Chinese Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study tests a new medicine called etavopivat in healthy Chinese participants. During the study, the participant will be given 1 dose of the study medicine. A dose is 2 tablets which are swallowed together with a cup of water. The study doctor will measure how much of the study medicine is in the blood as time passes. After the dose is given, the study will last for 7 to 9 days. The participants will attend a screening visit 2 to 28 days before they are given the study medicine. The participant will have 6 clinic visits in total. As part of the study, participant will stay overnight at the clinic for 3 nights. In some cases the doctor may decide that participant need to stay more nights. Participant will have blood tests and other health assessments at all 6 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If the participant do take part in the study, participant will need to refrain from certain activities and behaviours for up to 3 months before taking the study medicine. Participant will also need to go without food and drinks other than water in the 10 hours before and 4 hours after taking the medicine.

Conditions

• Healthy Volunteers
• Sickle Cell Disease
• Thalassemia

Interventions

Type	Name	Description
DRUG	Etavopivat	2 tablets of Etavopivat will be administered in fasted state via oral route

Timeline

• Start date: 2024-08-26
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2024-09-03
• Last updated: 2025-12-29

Locations

1 site across 1 country: China