A Research Study Looking at a Single Dose of Etavopivat in Healthy Chinese Participants
NCT06581627 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2025-12-29
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
- DRUG
-
Etavopivat
2 tablets of Etavopivat will be administered in fasted state via oral route
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Transparency '(dept. 2834)' · Novo Nordisk A/S
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-08-26
- Primary Completion
- 2024-10-31
- Completion
- 2024-10-31
Countries
- China
Study Locations
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