A Research Study Looking at a Single Dose of Etavopivat in Healthy Chinese Participants
NCT Number: NCT06581627
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers|Sickle Cell Disease|Thalassemia
Interventions: DRUG: Etavopivat
Sponsor: Novo Nordisk A/S
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-26
Completion Date: 2024-10-30
Locations: Beijing Hospital, Beijing, Beijing, 100730, China|Beijing Hospital, Beijing, Beijing, 100730, China

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.

Primary Outcome Measures: AUC0-inf,etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose, Measured in hour\*nanogram/millilitre (h\*ng/mL)., From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)|Cmax,etavopivat: Maximum observed etavopivat plasma concentration after a single dose, Measured in nanograms/millilitre (ng/mL)., From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)|Weight-adjusted AUC0-inf,etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose divided by body weight, Measured in(hour\*nanogram/millilitre)/kilograms ((h\*ng/mL)/kg)., From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)|Weight-adjusted Cmax,etavopivat: Maximum observed etavopivat plasma concentration after a single dose divided by body weight, Measured in (nanograms/millilitre )/kilogram ((ng/mL)/kg)., From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)|AUC0-last,etavopivat: Area under the etavopivat plasma concentration-time curve from0 hours to the time of last quantifiable concentration, Measured in hour\*nanogram/millilitre (h\*ng/mL)., From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)|tmax,etavopivat: Time to maximum observed etavopivat plasma concentration after a single dose, Measured in hour (h)., From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)|t½,etavopivat: Terminal half-life for etavopivat after a single dose, Measured in hour (h)., From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)|CL/F etavopivat: Apparent plasma clearance of etavopivat after a single dose, Measured in Litre/hour (L/h)., From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)|Vz/F etavopivat: Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values, Measure in litre (L)., From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Secondary Outcome Measures: Number of adverse events, Measured as count., From dosing (day 1) to end of study (day 7 to 9)