Healthy VolunteersPhase 1NCT07023029
A Study on the Effect of Etavopivat on Heart Rhythm in Healthy Participants
A Phase 1 study testing Etavopivat and Moxifloxacin in people with Healthy Volunteers and Sickle Cell Disease, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
Novo Nordisk is developing a new study medicine, Etavopivat, to treat individuals with sickle cell disease (SCD). The purpose of the study is to determine the effect of Etavopivat on the electrical activity of the heart in healthy participants. The study comprises two parts: Part A and Part B. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Sickle Cell Disease, Thalassemia
- What is being tested?
- Etavopivat and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2025to 22 Sep 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female.
- Aged 18-55 years (both inclusive) at the time of signing informed consent.
- Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m^2) (both inclusive) at screening.
- Body weight above 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, as defined in Appendix 4, Section 10.4.
- Current participation (i.e., signed informed consent) in any other interventional clinical study.
- Exposure to an investigational medicinal product within 30 days or 5 half-lives of the investigational medicinal product (IMP) (if known), whichever is longer, before screening.
- Any condition which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
- Second or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds (ms)., or of the corrected QT interval using the Fredericia formula (QTcF) over 450 ms for males and 470 ms for females, prominent U waves, or any other clinically significant abnormal ECG results or changes that make ECGs unsuitable for QT evaluations as judged by the investigator, at screening.
- Use of tobacco and nicotine products, defined as any of the below:
Show all 13Show fewer
- Has used any product containing tobacco or nicotine within 90 days prior to screening.
- Unable or unwilling to refrain from the use of any product containing tobacco or nicotine throughout the study.
- Positive nicotine test at screening.
- Participant is unable to refrain from or anticipates the use of antacids, iron, or any drug known to be a moderate or strong inhibitor or inducer of uridine 5'-diphosphoglucuronosyltransferase (UGT) enzymes, cytochrome P450 (CYP) 3A4, CYP2C9 or permeability glycoprotein (P-gp), including St. John's Wort, for 28 days prior to dosing and throughout the study (Section 6.8).
- Participant is unable to refrain from or anticipate the use of any medications or substances prohibited in the study (Sections 5.3, 5.5 and 6.8).
- A minimum of 20% African-American participants will be included in each part of this study.
- Efforts will be made to include at least 40 percentage (%) of each sex into each part of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
PAREXEL Intl - EPCU-Baltimore
Baltimore, Maryland, 21225
About this study
Official title: A Study to Assess the Effect of Etavopivat on Cardiac Repolarisation in Healthy Participants
Novo Nordisk is developing a new study medicine, Etavopivat, to treat individuals with sickle cell disease (SCD). The purpose of the study is to determine the effect of Etavopivat on the electrical activity of the heart in healthy participants. The study comprises two parts: Part A and Part B. Part A investigates the safety of a high dose of Etavopivat. In this phase, participants will receive either a single dose of Etavopivat or a placebo. Which treatment the participant gets is decided by chance. In Part B, participants will get four different treatments on four different occasions: Etavopivat in 2 different doses (the new medicine that cannot be prescribed), a dummy medicine (placebo), and an already approved medicine (moxifloxacin). The order of the 4 study medicines is decided by chance. There will be a break of 7 days between each treatment. For Part A, the study duration will be from 10 to 36 days, and for Part B, the study duration will be from 27 to 53 days.
- Conditions
- Healthy Volunteers, Sickle Cell Disease, Thalassemia
- Being tested
- Etavopivat, Moxifloxacin, Placebo
- 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
Etavopivat will be administered orally.
MoxifloxacinDrug
Moxifloxacin will be administered orally.
PlaceboDrug
Placebo matching Etavopivat will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part A- Etavopivat | Experimental | Participants will receive a single dose of etavopivat. Receives: Drug: Etavopivat |
| Part A- Placebo | Placebo comparator | Participants will receive a single dose of placebo. Receives: Drug: Placebo |
| Part B- Etavopivat | Experimental | Participants will receive a single dose of etavopivat. Receives: Drug: Etavopivat |
| Part B- Moxifloxacin | Other | Participants will receive a single dose of moxifloxacin. Receives: Drug: Moxifloxacin |
| Part B- Placebo | Placebo comparator | Participants will receive a single dose of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of treatment-emergent adverse events (AEs)
Measured as count of events.
Measured: From dosing (Day 1) until end of study (Day 8)
Part B: Change from baseline in Fridericia heart rate corrected QT interval (ΔQTcF) for etavopivat
Measured as milliseconds.
Measured: From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23
Secondary outcomes (18)
Part A: Number of treatment-emergent clinically significant abnormal findings in electrocardiogram (ECGs)
Measured as count of treatment-emergent clinically significant abnormal findings in ECGs.
Measured: From dosing (Day 1) until end of study (Day 8)
Parts A and B: Cmax,etavopivat- Maximum observed etavopivat plasma concentration after a single dose
Measured as nanograms per milliliter (ng/mL).
Measured: Day 1 (Part B)/ From day 1 to day 5 (Part A) after investigational medicinal product (IMP) administration
Parts A and B: AUC0-last,etavopivat- Area under the etavopivat plasma concentration-time curve from 0 hours to the time of last quantifiable concentration
Measured as hours*nanograms per milliliter (h*ng/mL).
Measured: Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration
Parts A and B: AUC0-inf,etavopivat- Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose
Measured as h*ng/mL.
Measured: Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration
Parts A and B: tmax,etavopivat- Time to maximum observed etavopivat plasma concentration after a single dose
Measured as hours.
Measured: Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration
Parts A and B: t½ etavopivat- Terminal half-life for etavopivat after a single dose
Measured as hours.
Measured: Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration
Parts A and B: CL/F etavopivat- Apparent plasma clearance of etavopivat after a single dose
Measured as liters per hour (L/h).
Measured: Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration
Parts A and B: Vz/F etavopivat- Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values
Measured as liters (L).
Measured: Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration
Part B: ΔQTcF for moxifloxacin
Measured as milliseconds.
Measured: From pre-dose to post moxifloxacin dose on day 1 to day 23
Part B: Change from baseline in heart rate (ΔHR). Categorical outliers for HR
Measured as milliseconds.
Measured: From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23
Part B: Change from baseline in PR interval (ΔPR). Categorical outliers for PR
Measured as milliseconds.
Measured: From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23
Part B: Change from baseline in QRS complex duration (ΔQRS). Categorical outliers for QRS
Measured as milliseconds.
Measured: From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23
Part B: Frequency of treatment emergent changes of ECG morphology
Measured as count of treatment emergent changes of ECG morphology.
Measured: From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23
Part B: Change from baseline in ΔHR. Categorical outliers for HR
Measured as milliseconds.
Measured: From pre-dose to post moxifloxacin dose on day 1 to day 23
Part B: Change from baseline in ΔPR. Categorical outliers for PR
Measured as milliseconds.
Measured: From pre-dose to post moxifloxacin dose on day 1 to day 23
Part B: Change from baseline in ΔQRS. Categorical outliers for QRS
Measured as milliseconds.
Measured: From pre-dose to post moxifloxacin dose on day 1 to day 23
Part B: Frequency of treatment emergent changes of ECG morphology
Measured as count of treatment emergent changes of ECG morphology.
Measured: From pre-dose to post moxifloxacin dose on day 1 to day 23
Part B: ΔQTcF for etavopivat
Measured as milliseconds.
Measured: From pre-dose to post etavopivat/etavopivat placebo dose on day 1 to day 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start9 Jun 2025
- Primary completion12 Sep 2025
- Study completion22 Sep 2025
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
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 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
- NCT07023029
- Sponsor's protocol ID
- NN7535-7975
- Other IDs
- U1111-1314-5780
- Status last verified
- Dec 2025
- First submitted
- 8 Jun 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Effect of Etavopivat on Cardiac Repolarisation in Healthy Participants
- ClinicalTrials.gov ID
- NCT07023029
- Acronym / sponsor ID
- NN7535-7975
- Conditions
- Healthy Volunteers, Sickle Cell Disease, Thalassemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 15 Jun 2025 (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.
Novo Nordisk is developing a new study medicine, Etavopivat, to treat individuals with sickle cell disease (SCD). The purpose of the study is to determine the effect of Etavopivat on the electrical activity of the heart in healthy participants. The study comprises two parts: Part A and Part B. Part A investigates the safety of a high dose of Etavopivat. In this phase, participants will receive either a single dose of Etavopivat or a placebo. Which treatment the participant gets is decided by chance. In Part B, participants will get four different treatments on four different occasions: Etavopivat in 2 different doses (the new medicine that cannot be prescribed), a dummy medicine (placebo), and an already approved medicine (moxifloxacin). The order of the 4 study medicines is decided by chance. There will be a break of 7 days between each treatment. For Part A, the study duration will be from 10 to 36 days, and for Part B, the study duration will be from 27 to 53 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A- Etavopivat | Experimental | Drug: EtavopivatParticipants will receive a single dose of etavopivat. |
| Part A- Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of placebo. |
| Part B- Etavopivat | Experimental | Drug: EtavopivatParticipants will receive a single dose of etavopivat. |
| Part B- Moxifloxacin | Other | Drug: MoxifloxacinParticipants will receive a single dose of moxifloxacin. |
| Part B- Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female.
- Aged 18-55 years (both inclusive) at the time of signing informed consent.
- Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m^2) (both inclusive) at screening.
- Body weight above 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 (13 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods, as defined in Appendix 4, Section 10.4.
- Current participation (i.e., signed informed consent) in any other interventional clinical study.
- Exposure to an investigational medicinal product within 30 days or 5 half-lives of the investigational medicinal product (IMP) (if known), whichever is longer, before screening.
- Any condition which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
- Second or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds (ms)., or of the corrected QT interval using the Fredericia formula (QTcF) over 450 ms for males and 470 ms for females, prominent U waves, or any other clinically significant abnormal ECG results or changes that make ECGs unsuitable for QT evaluations as judged by the investigator, at screening.
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 |
|---|---|---|
| EtavopivatEtavopivat will be administered orally. | Drug | Part A- Etavopivat, Part B- Etavopivat |
| MoxifloxacinMoxifloxacin will be administered orally. | Drug | Part B- Moxifloxacin |
| PlaceboPlacebo matching Etavopivat will be administered orally. | Drug | Part A- Placebo, Part B- Placebo |
Primary outcome
Part A: Number of treatment-emergent adverse events (AEs)
Time frame: From dosing (Day 1) until end of study (Day 8)
Measured as count of events.
Part B: Change from baseline in Fridericia heart rate corrected QT interval (ΔQTcF) for etavopivat
Time frame: From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23
Measured as milliseconds.
18 secondary outcomes
Part A: Number of treatment-emergent clinically significant abnormal findings in electrocardiogram (ECGs)
Time frame: From dosing (Day 1) until end of study (Day 8)
Parts A and B: Cmax,etavopivat- Maximum observed etavopivat plasma concentration after a single dose
Time frame: Day 1 (Part B)/ From day 1 to day 5 (Part A) after investigational medicinal product (IMP) administration
Parts A and B: AUC0-last,etavopivat- Area under the etavopivat plasma concentration-time curve from 0 hours to the time of last quantifiable concentration
Time frame: Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration
Parts A and B: AUC0-inf,etavopivat- Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose
Time frame: Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration
Parts A and B: tmax,etavopivat- Time to maximum observed etavopivat plasma concentration after a single dose
Time frame: Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration
Parts A and B: t½ etavopivat- Terminal half-life for etavopivat after a single dose
Time frame: Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration
Parts A and B: CL/F etavopivat- Apparent plasma clearance of etavopivat after a single dose
Time frame: Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration
Parts A and B: Vz/F etavopivat- Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values
Time frame: Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration
Part B: ΔQTcF for moxifloxacin
Time frame: From pre-dose to post moxifloxacin dose on day 1 to day 23
Part B: Change from baseline in heart rate (ΔHR). Categorical outliers for HR
Time frame: From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23
Part B: Change from baseline in PR interval (ΔPR). Categorical outliers for PR
Time frame: From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23
Part B: Change from baseline in QRS complex duration (ΔQRS). Categorical outliers for QRS
Time frame: From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23
Part B: Frequency of treatment emergent changes of ECG morphology
Time frame: From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23
Part B: Change from baseline in ΔHR. Categorical outliers for HR
Time frame: From pre-dose to post moxifloxacin dose on day 1 to day 23
Part B: Change from baseline in ΔPR. Categorical outliers for PR
Time frame: From pre-dose to post moxifloxacin dose on day 1 to day 23
Part B: Change from baseline in ΔQRS. Categorical outliers for QRS
Time frame: From pre-dose to post moxifloxacin dose on day 1 to day 23
Part B: Frequency of treatment emergent changes of ECG morphology
Time frame: From pre-dose to post moxifloxacin dose on day 1 to day 23
Part B: ΔQTcF for etavopivat
Time frame: From pre-dose to post etavopivat/etavopivat placebo dose on day 1 to day 23
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 2 Jan 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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 and Moxifloxacin in people with Healthy Volunteers and Sickle Cell Disease, run by Novo Nordisk A/S at 1 site in United States.
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 13 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 2 Jan 2026. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Part A: Number of treatment-emergent adverse events (AEs) (time frame: From dosing (Day 1) until end of study (Day 8)). The study lists 2 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 2 Jan 2026.