Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581627
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
A Research Study Looking at a Single Dose of Etavopivat in Healthy Chinese Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None