Beijing Hospital
Beijing, Beijing Municipality, 100730, China
NCT Number: NCT06581627
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.
Looking for future studies?
Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Beijing, Beijing Municipality, 100730, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 tablets of Etavopivat will be administered in fasted state via oral route
Time frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Measured in hour*nanogram/millilitre (h*ng/mL).
Time frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Measured in nanograms/millilitre (ng/mL).
Time frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Measured in(hour*nanogram/millilitre)/kilograms ((h*ng/mL)/kg).
Time frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Measured in (nanograms/millilitre )/kilogram ((ng/mL)/kg).
Time frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Measured in hour*nanogram/millilitre (h*ng/mL).
Time frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Measured in hour (h).
Time frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Measured in hour (h).
Time frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Measured in Litre/hour (L/h).
Time frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Measure in litre (L).
Time frame: From dosing (day 1) to end of study (day 7 to 9)
Measured as count.
Novo Nordisk A/S
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07023029
Anemia, Anemia, Hemolytic
Baltimore, Maryland, United States
View Trial DetailsNCT03815695
Anemia, Anemia, Hemolytic
Little Rock, Arkansas, United States
View Trial DetailsNCT04536792
Anemia, Anemia, Hemolytic
La Jolla, California, United States
View Trial DetailsNCT06481306
Anemia, Anemia, Hemolytic
Birmingham, Alabama, United States
View Trial Details