A Phase 1 interventional study of Etavopivat in Healthy Volunteers, Sickle Cell Disease and Thalassemia, sponsored by Novo Nordisk A/S. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
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.
1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.
This study's enrollment of 24 is below the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be administered a single dose of 2 tablets of etavopivat together.
Drug: Etavopivat
2 tablets of Etavopivat will be administered in fasted state via oral route
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Number of adverse events
Measured as count.
Time frame: From dosing (day 1) to end of study (day 7 to 9)
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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