Healthy Volunteers Sickle Cell Disease, ThalassemiaPhase 1NCT06433661
A Research Study of the Effect of Food on Etavopivat in Healthy Participants
A Phase 1 study testing Etavopivat in people with Healthy Volunteers Sickle Cell Disease, Thalassemia, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of food on the amount of etavopivat in the bloodstream of healthy participants. Participants will take a single oral dose of etavopivat following a high-fat meal (i.e. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2024to 8 Jul 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female.
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 18.5 and 39.9 kilogram per meter square (kg/m^2) (both inclusive) at screening.
- Body weight greater than or equal to (≥) 40.0 kilogram (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 30 days or 5 times the half-life of the previous investigational medicinal 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 tobacco and nicotine products, defined as any of the below:
- 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,
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- Positive nicotine test at screening.
- Participant is unable to refrain from or anticipates the use of any drug known to be a moderate or strong inhibitor or inducer of uridine 5'-diphospho-glucuronosyltransferase (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.
- Participant is unable to refrain from or anticipate the use of any medications or substances prohibited in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Open-label, Randomised, Single-dose, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Etavopivat in Healthy Participants
The purpose of this study is to evaluate the effect of food on the amount of etavopivat in the bloodstream of healthy participants. Participants will take a single oral dose of etavopivat following a high-fat meal (i.e. fed) and on an empty stomach (i.e fasted) on two separate occasions.The study will last up to 50 days (including screening).
- Being tested
- Etavopivat
- Medical subject headings
- Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtavopivatDrug
Participants will receive single dose of oral Etavopivat in each treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Etavopivat: fed-fasted | Experimental | Participants will receive a single dose of Etavopivat in fed condition in period 1 and a single dose of Etavopivat in fasted condition in period 2. Receives: Drug: Etavopivat |
| Sequence 2: Etavopivat: fasted-fed | Experimental | Participants will receive a single dose of Etavopivat in fasted condition in period 1 and a single dose of Etavopivat in fed condition in period 2. 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 as hours nanograms per milliliter (h*ng/mL).
Measured: From 0 to 120 hours after IMP administration (V2/V6)
Cmax, etavopivat: Maximum observed etavopivat plasma concentration after a single dose
Measured as nanograms per milliliter (ng/mL).
Measured: From 0 to 120 hours after IMP administration (V2/V6)
Secondary outcomes (6)
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: From 0 to 120 hours after IMP administration (V2/V6)
tmax, etavopivat: Time to maximum observed etavopivat plasma concentration after a single dose
Measured as hours.
Measured: From 0 to 120 hours after IMP administration (V2/V6)
t1/2, etavopivat: Terminal half-life for etavopivat after a single dose
Measured as hours.
Measured: From 0 to 120 hours after IMP administration (V2/V6)
CL/Fetavopivat: Apparent plasma clearance of etavopivat after a single dose
Measured as liter per hours (L/h).
Measured: From 0 to 120 hours after IMP administration (V2/V6)
Vz/Fetavopivat: Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values
Measured as liters (L).
Measured: From 0 to 120 hours after IMP administration (V2/V6)
Number of adverse events
Measured as count of events.
Measured: From IMP administration on day 1 to completion of the end of study visit (V10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start28 May 2024
- Primary completion6 Jul 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers Sickle Cell Disease, ThalassemiaStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT06433661
- Sponsor's protocol ID
- NN7535-7702
- Other IDs
- U1111-1289-2544
- Status last verified
- Oct 2025
- First submitted
- 22 May 2024
- Last updated
- 10 Oct 2025
- 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 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Open-label, Randomised, Single-dose, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Etavopivat in Healthy Participants
- ClinicalTrials.gov ID
- NCT06433661
- Acronym / sponsor ID
- NN7535-7702
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 28 May 2024 (actual)
- Primary completion
- 6 Jul 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 30 May 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 purpose of this study is to evaluate the effect of food on the amount of etavopivat in the bloodstream of healthy participants. Participants will take a single oral dose of etavopivat following a high-fat meal (i.e. fed) and on an empty stomach (i.e fasted) on two separate occasions.The study will last up to 50 days (including screening).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Etavopivat: fed-fasted | Experimental | Drug: EtavopivatParticipants will receive a single dose of Etavopivat in fed condition in period 1 and a single dose of Etavopivat in fasted condition in period 2. |
| Sequence 2: Etavopivat: fasted-fed | Experimental | Drug: EtavopivatParticipants will receive a single dose of Etavopivat in fasted condition in period 1 and a single dose of Etavopivat in fed condition in period 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female.
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 18.5 and 39.9 kilogram per meter square (kg/m^2) (both inclusive) at screening.
- Body weight greater than or equal to (≥) 40.0 kilogram (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 (9 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 30 days or 5 times the half-life of the previous investigational medicinal 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 tobacco and nicotine products, defined as any of the below:
- Has used any product containing tobacco or nicotine within 90 days prior to 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 |
|---|---|---|
| EtavopivatParticipants will receive single dose of oral Etavopivat in each treatment period. | Drug | Sequence 1: Etavopivat: fed-fasted, Sequence 2: Etavopivat: fasted-fed |
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 IMP administration (V2/V6)
Measured as hours nanograms per milliliter (h*ng/mL).
Cmax, etavopivat: Maximum observed etavopivat plasma concentration after a single dose
Time frame: From 0 to 120 hours after IMP administration (V2/V6)
Measured as nanograms per milliliter (ng/mL).
6 secondary outcomes
AUC0-last, etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours to the time of last quantifiable concentration
Time frame: From 0 to 120 hours after IMP administration (V2/V6)
tmax, etavopivat: Time to maximum observed etavopivat plasma concentration after a single dose
Time frame: From 0 to 120 hours after IMP administration (V2/V6)
t1/2, etavopivat: Terminal half-life for etavopivat after a single dose
Time frame: From 0 to 120 hours after IMP administration (V2/V6)
CL/Fetavopivat: Apparent plasma clearance of etavopivat after a single dose
Time frame: From 0 to 120 hours after IMP administration (V2/V6)
Vz/Fetavopivat: Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values
Time frame: From 0 to 120 hours after IMP administration (V2/V6)
Number of adverse events
Time frame: From IMP administration on day 1 to completion of the end of study visit (V10)
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 10 Oct 2025.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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 Sickle Cell Disease, Thalassemia, 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 9 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 10 Oct 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 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. 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 IMP administration (V2/V6)). 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 10 Oct 2025.