Healthy VolunteersPhase 1NCT06581627
A Research Study Looking at a Single Dose of Etavopivat in Healthy Chinese Participants
A Phase 1 study testing Etavopivat in people with Healthy Volunteers and Sickle Cell Disease, run by Novo Nordisk A/S at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Sickle Cell Disease, Thalassemia
- What is being tested?
- Etavopivat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2024to 31 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female Chinese participants.
- Age 18-45 years (both inclusive) at the time of signing the informed consent form.
- Body mass index (BMI) between 18.0 and 33.0 kg/m^2 (both inclusive) at screening.
- Body weight greater than or equal to 40.0 kg at screening.
- Considered to be generally healthy based on the medical history, physical examination and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Who cannot join
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods.
- Participation (i.e., signed informed consent) in any other interventional clinical study within 90 days or 5 times the half-life of the previous investigational medical product (IMP) (if known), whichever is longer before screening.
- Any disorder, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
- Use of any medication with unknown or unspecified content within 90 days before screening.
- Use of prescription medicinal products or non-prescription drugs (including Chinese traditional medicine or local medicine) within 14 days before screening, as declared by the participant, apart from:
- Acceptable contraceptive methods
Show all 18Show fewer
- Hormone replacement therapy (for menopausal females)
- Over-the-counter topical medications known to not reach systemic circulation
- Occasional use of:
- Acetaminophen up to 2 grams (g) (4 x 0.5 g) daily
- Ibuprofen up to 2.4 g (4 x 0.6 g) daily
- Acetylsalicylic acid up to 2.4 g (4 x 0.6 g) daily
- Is unable to refrain from or anticipates the use of any drug known to be a strong or moderate inhibitor or inducer of uridine 5'-diphospho glucuronosyltransferase (UGT) enzymes, cytochrome P450 (CYP) 3A4, CYP2C9 or permeability glycoproteins (P-gp), including St. John's Wort, for 28 days prior to dosing and throughout the study
- Is unable to refrain from or anticipates the use of any medications or substances prohibited in the study
- Use of tobacco and nicotine products, defined as any of the following:
- Has used any product containing tobacco or nicotine within 90 days prior to screening
- Not willing to refrain from the use of any product containing tobacco or nicotine throughout the study
- Positive nicotine test at screening
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Etavopivat
- Medical subject headings
- Anemia, Sickle Cell, Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtavopivatDrug
2 tablets of Etavopivat will be administered in fasted state via oral route
| Study group | Role | What they receive |
|---|---|---|
| Etavopivat | Experimental | Participants will be administered a single dose of 2 tablets of etavopivat together. Receives: Drug: Etavopivat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Secondary outcomes (1)
Number of adverse events
Measured as count.
Measured: From dosing (day 1) to end of study (day 7 to 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start26 Aug 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency '(dept. 2834)', Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581627
- Sponsor's protocol ID
- NN7535-7704
- Other IDs
- U1111-1294-7463
- Status last verified
- Dec 2025
- First submitted
- 30 Aug 2024
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06581627
- Acronym / sponsor ID
- NN7535-7704
- Conditions
- Healthy Volunteers, Sickle Cell Disease, Thalassemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etavopivat | Experimental | Drug: EtavopivatParticipants will be administered a single dose of 2 tablets of etavopivat together. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female Chinese participants.
- Age 18-45 years (both inclusive) at the time of signing the informed consent form.
- Body mass index (BMI) between 18.0 and 33.0 kg/m^2 (both inclusive) at screening.
- Body weight greater than or equal to 40.0 kg at screening.
- Considered to be generally healthy based on the medical history, physical examination and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Key exclusion criteria (18 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods.
- Participation (i.e., signed informed consent) in any other interventional clinical study within 90 days or 5 times the half-life of the previous investigational medical product (IMP) (if known), whichever is longer before screening.
- Any disorder, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
- Use of any medication with unknown or unspecified content within 90 days before screening.
- Use of prescription medicinal products or non-prescription drugs (including Chinese traditional medicine or local medicine) within 14 days before screening, as declared by the participant, apart from:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etavopivat2 tablets of Etavopivat will be administered in fasted state via oral route | Drug | Etavopivat |
Primary outcome
AUC0-inf,etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose
Time frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Measured in hour*nanogram/millilitre (h*ng/mL).
Cmax,etavopivat: Maximum observed etavopivat plasma concentration after a single dose
Time frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Measured in nanograms/millilitre (ng/mL).
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
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).
Weight-adjusted Cmax,etavopivat: Maximum observed etavopivat plasma concentration after a single dose divided by body weight
Time frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Measured in (nanograms/millilitre )/kilogram ((ng/mL)/kg).
AUC0-last,etavopivat: Area under the etavopivat plasma concentration-time curve from0 hours to the time of last quantifiable concentration
Time frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Measured in hour*nanogram/millilitre (h*ng/mL).
tmax,etavopivat: Time to maximum observed etavopivat plasma concentration after a single dose
Time frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Measured in hour (h).
t½,etavopivat: Terminal half-life for etavopivat after a single dose
Time frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Measured in hour (h).
CL/F etavopivat: Apparent plasma clearance of etavopivat after a single dose
Time frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Measured in Litre/hour (L/h).
Vz/F etavopivat: Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values
Time frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Measure in litre (L).
1 secondary outcome
Number of adverse events
Time frame: From dosing (day 1) to end of study (day 7 to 9)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency '(dept. 2834)' study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Etavopivat in people with Healthy Volunteers and Sickle Cell Disease, run by Novo Nordisk A/S at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-inf,etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose (time frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.