Healthy Volunteers Sickle Cell Disease, ThalassemiaPhase 1NCT06813924
A Research Study of the Effect of Etavopivat on Other Drugs in Healthy Participants
A Phase 1 study testing Etavopivat, Digoxin and Pitavastatin in people with Healthy Volunteers Sickle Cell Disease, Thalassemia, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
The study aims to test if a new medicine called etavopivat potentially affects other medicines in healthy participants. The purpose of the study is to investigate whether the use of etavopivat affects the breakdown and metabolism of commonly used medicines in the body. 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, Digoxin and Pitavastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2025to 27 May 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
- Body mass index (BMI) between 18.5 and 29.9 kilograms per square meter (kg/m^2) (both inclusive) at screening.
- Body weight greater than (>) 50.0 kg at screening.
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Who cannot join
- Known or suspected hypersensitivity to study interventions or related products.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- Exposure to an investigational medicinal product within 30 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before 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, CYP3A4, CYP2C9, MATE1, OATP1B1/1B3, BCRP, OCT2, or P-gp, including St. John's Wort for 28 days prior to dosing and throughout the study.
- Use of any medication with unknown or unspecified content within 90 days before screening.
- Use of or intent to use prescription medicinal products or non-prescription drugs (including vitamins and herbal supplements) within 14 days prior to dosing and throughout the study, as declared by the participant, except for:
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- Adequate contraceptive methods.
- Hormone replacement therapy (HRT) (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.
- Not able or not willing to adhere to study procedures, including:
- Eating the food provided in the study.
- Refraining from ingesting food or drinks that are not allowed during the study.
- Swallowing tablets.
- Abstaining from concomitant medication not allowed during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Fixed-Sequence Study to Evaluate the Effect of Etavopivat on the Single-Dose Pharmacokinetics of Midazolam, Digoxin, Rosuvastatin, Pitavastatin, and Metformin in Healthy Adult Participants
The study aims to test if a new medicine called etavopivat potentially affects other medicines in healthy participants. The purpose of the study is to investigate whether the use of etavopivat affects the breakdown and metabolism of commonly used medicines in the body. During the study, participants will receive etavopivat and five different medicines that are already approved and available on the market, and which can be prescribed by doctors. These marketed medicines are called substrate drugs and they are: digoxin, pitavastatin, metformin, midazolam, and rosuvastatin. During a period of the study, participants will take 2 tablets of etavopivat daily for 10 consecutive days. The study will last for about 34 to 64 days.
- 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 a daily dose of etavopivat orally.
DigoxinDrug
Participants will receive a single dose of digoxin orally.
PitavastatinDrug
Participants will receive a single dose of pitavastatin orally.
MetforminDrug
Participants will receive a single dose of metformin orally.
MidazolamDrug
Participants will receive a single dose of midazolam orally.
RosuvastatinDrug
Participants will receive a single dose of rosuvastatin orally.
| Study group | Role | What they receive |
|---|---|---|
| Period 1: digoxin+pitavastatin+metformin | Experimental | Participants will receive a single dose of oral digoxin, pitavastatin and metformin. Receives: Drug: Digoxin; Drug: Pitavastatin; Drug: Metformin |
| Period 1: midazolam+rosuvastatin | Experimental | Participants will receive a single dose of oral midazolam and rosuvastatin. Receives: Drug: Midazolam; Drug: Rosuvastatin |
| Period 2: etavopivat+midazolam | Experimental | Participants will receive a daily dose of oral etavopivat and single dose of oral midazolam. Receives: Drug: Etavopivat; Drug: Midazolam |
| Period 2: etavopivat+midazolam+rosuvastatin | Experimental | Participants will receive a daily dose of oral etavopivat, single dose of oral midazolam and rosuvastatin. Receives: Drug: Etavopivat; Drug: Midazolam; Drug: Rosuvastatin |
| Period 2: etavopivat+digoxin+pitavastatin+metformin | Experimental | Participants will receive a daily dose of oral etavopivat, single dose of oral digoxin, pitavastatin and metformin. Receives: Drug: Etavopivat; Drug: Digoxin; Drug: Pitavastatin; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax, digoxin, SD: Maximum observed digoxin plasma concentration with and without etavopivat at steady state
Measured as picograms per milliliter (pg/mL).
Measured: Day 1 and day 3 after digoxin administration
AUC0-inf, digoxin, SD: Area under the digoxin plasma concentration-time curve from 0 hours and extrapolated to infinity with and without etavopivat at steady state
Measured as hours*picograms per milliliter (h*pg/mL).
Measured: Day 1 and day 3 after digoxin administration
Cmax, rosuvastatin, SD: Maximum observed rosuvastatin plasma concentration with and without etavopivat at steady state
Measured as pg/mL.
Measured: Day 1 after rosuvastatin administration
AUC0-inf, rosuvastatin, SD: Area under the rosuvastatin plasma concentration-time curve from 0 hours and extrapolated to infinity with and without etavopivat at steady state
Measured as h*pg/mL.
Measured: Day 1 after rosuvastatin administration
Cmax, midazolam, SD: Maximum observed midazolam plasma concentration without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Measured as pg/mL.
Measured: Day 1 after midazolam administration
AUC0-inf, midazolam, SD: Area under the midazolam plasma concentration-time curve from 0 hours and extrapolated to infinity without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Measured as h*pg/mL.
Measured: Day 1 after midazolam administration
Cmax, pitavastatin, SD: Maximum observed pitavastatin plasma concentration with and without etavopivat at steady state
Measured as nanograms per milliliter (ng/mL).
Measured: Day 1 and day 3 after pitavastatin administration
AUC0-inf, pitavastatin, SD: Area under the pitavastatin plasma concentration-time curve from 0 hours and extrapolated to infinity with and without etavopivat at steady state
Measured as hours*nanograms per milliliter(h*ng/mL).
Measured: Day 1 and day 3 after pitavastatin administration
Cmax, metformin, SD: Maximum observed metformin plasma concentration with and without etavopivat at steady state
Measured as ng/mL.
Measured: Day 1 and day 3 after metformin administration
AUC0-inf, metformin, SD: Area under the metformin plasma concentration-time curve from 0 hours and extrapolated to infinity with and without etavopivat at steady state
Measured as h*ng/mL.
Measured: Day 1 and day 3 after metformin administration
Secondary outcomes (43)
AUC0-last, digoxin, SD: Area under the digoxin plasma concentration-time curve from 0 hours to the last quantifiable concentration with and without etavopivat at steady state
Measured as h*pg/mL.
Measured: Day 1 and day 3 after digoxin administration
t1/2, digoxin, SD: Terminal half-life for digoxin with and without etavopivat at steady state
Measured as hours.
Measured: Day 1 and day 3 after digoxin administration
tmax, digoxin, SD: Time to maximum observed digoxin plasma concentration with and without etavopivat at steady state
Measured as hours.
Measured: Day 1 and day 3 after digoxin administration
CL/Fdigoxin, SD: Apparent plasma clearance of digoxin with and without etavopivat at steady state
Measured as liters per hour (L/h).
Measured: Day 1 and day 3 after digoxin administration
Vz/Fdigoxin, SD: Apparent volume of distribution of digoxin with and without etavopivat at steady state based on plasma concentration values
Measured as liters (L).
Measured: Day 1 and day 3 after digoxin administration
AUC0-last, rosuvastatin, SD: Area under the rosuvastatin plasma concentration-time curve from 0 hours to the last quantifiable concentration with and without etavopivat at steady state
Measured as h*pg/mL.
Measured: Day 1 after rosuvastatin administration
t1/2, rosuvastatin, SD: Terminal half-life for rosuvastatin with and without etavopivat at steady state
Measured as hours.
Measured: Day 1 after rosuvastatin administration
tmax, rosuvastatin, SD: Time to maximum observed rosuvastatin plasma concentration with and without etavopivat at steady state
Measured as hours.
Measured: Day 1 after rosuvastatin administration
CL/Frosuvastatin, SD: Apparent plasma clearance of rosuvastatin with and without etavopivat at steady state
Measured as L/h.
Measured: Day 1 after rosuvastatin administration
Vz/Frosuvastatin, SD: Apparent volume of distribution of rosuvastatin with and without etavopivat at steady state based on plasma concentration values
Measured as L.
Measured: Day 1 after rosuvastatin administration
AUC0-last, midazolam, SD: Area under the midazolam plasma concentration-time curve from 0 hours to the last quantifiable concentration without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Measured as h*pg/mL.
Measured: Day 1 after midazolam administration
t1/2, midazolam, SD: Terminal half-life for midazolam without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Measured as hours.
Measured: Day 1 after midazolam administration
tmax, midazolam, SD: Time to maximum observed midazolam plasma concentration without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Measured as hours.
Measured: Day 1 after midazolam administration
CL/Fmidazolam, SD: Apparent plasma clearance of midazolam without etavopivat, with a single dose of etavopivat and with etavopivat at steady state
Measured as L/h.
Measured: Day 1 after midazolam administration
Vz/Fmidazolam, SD: Apparent volume of distribution of midazolam without etavopivat, with a single dose of etavopivat and with etavopivat at steady state
Measured as L.
Measured: Day 1 after midazolam administration
AUC0-inf, 1-hydroxymidazolam, SD: Area under the midazolam plasma concentration-time curve from 0 hours and extrapolated to infinity without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Measured as h*pg/mL.
Measured: Day 1 after midazolam administration
Cmax, 1-hydroxymidazolam, SD: Maximum observed midazolam plasma concentration without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Measured as pg/mL.
Measured: Day 1 after midazolam administration
AUC0-last, 1-hydroxymidazolam, SD: Area under the midazolam plasma concentration-time curve from 0 hours to the last quantifiable concentration without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Measured as h*pg/mL.
Measured: Day 1 after midazolam administration
t1/2, 1-hydroxymidazolam: Terminal half-life for 1-hydroxymidazolam without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Measured as hours.
Measured: Day 1 after midazolam administration
tmax, 1-hydroxymidazolam: Time to maximum observed 1-hydroxymidazolam plasma concentration without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Measured as hours.
Measured: Day 1 after midazolam administration
CL/F1-hydroxymidazolam: Apparent plasma clearance of 1-hydroxymidazolam without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Measured as L/h.
Measured: Day 1 after midazolam administration
Vz/F1-hydroxymidazolam: Apparent volume of distribution of 1-hydroxymidazolam based on plasma concentration values without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Measured as L.
Measured: Day 1 after midazolam administration
AUC0-last, pitavastatin, SD: Area under the pitavastatin plasma concentration-time curve from 0 hours to the last quantifiable concentration with and without etavopivat at steady state
Measured as h*ng/mL.
Measured: Day 1 and day 3 after pitavastatin administration
t1/2, pitavastatin, SD: Terminal half-life for pitavastatin with and without etavopivat at steady state
Measured as hours.
Measured: Day 1 and day 3 after pitavastatin administration
tmax, pitavastatin, SD: Time to maximum observed pitavastatin plasma concentration with and without etavopivat at steady state
Measured as hours.
Measured: Day 1 and day 3 after pitavastatin administration
CL/Fpitavastatin, SD: Apparent plasma clearance of pitavastatin with and without etavopivat at steady state
Measured as L/h.
Measured: Day 1 and day 3 after pitavastatin administration
Vz/Fpitavastatin, SD: Apparent volume of distribution of pitavastatin with and without etavopivat at steady state based on plasma concentration values
Measured as L.
Measured: Day 1 and day 3 after pitavastatin administration
AUC0-last, metformin, SD: Area under the metformin plasma concentration-time curve from 0 hours to the last quantifiable concentration with and without etavopivat at steady state
Measured as h*ng/mL.
Measured: Day 1 and day 3 after metformin administration
t1/2, metformin, SD: Terminal half-life for metformin with and without etavopivat at steady state
Measured as hours.
Measured: Day 1 and day 3 after metformin administration
tmax, metformin, SD: Time to maximum observed metformin plasma concentration with and without etavopivat at steady state
Measured as hours.
Measured: Day 1 and day 3 after metformin administration
CL/Fmetformin, SD: Apparent plasma clearance of metformin with and without etavopivat at steady state
Measured as L/h.
Measured: Day 1 and day 3 after metformin administration
Vz/Fmetformin, SD: Apparent volume of distribution of metformin with and without etavopivat at steady state based on plasma concentration values
Measured as L.
Measured: Day 1 and day 3 after metformin administration
Aelast, metformin, SD%: Percentage of the metformin excreted into urine from the time of dosing to the collection time of the last measurable concentration with and without etavopivat at steady state
Measured as percentage (%) of the metformin excreted into urine.
Measured: Day 1 and day 3 after metformin administration
CLR, metformin, SD: Renal clearance of metformin
Measured as L/h.
Measured: Day 1 and day 3 after metformin administration
AUC0-tau, etavopivat: Area under the etavopivat plasma concentration-time curve during one dosing interval at single dose and at steady state
Measured as h*ng/mL.
Measured: Day 1 and day 3 after etavopivat administration
AUC0-last etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours to the last quantifiable concentration at single dose and at steady state
Measured as h*ng/mL.
Measured: Day 1 and day 3 after etavopivat administration
Cmax, etavopivat: Maximum observed etavopivat plasma concentration at single dose and at steady state
Measured as ng/mL.
Measured: Day 1 and day 3 after etavopivat administration
t1/2, etavopivat: Terminal half-life for etavopivat at single dose and at steady state
Measured as hours.
Measured: Day 1 and day 3 after etavopivat administration
tmax, etavopivat: Time to maximum observed etavopivat plasma concentration at single dose and at steady state
Measured as hours.
Measured: Day 1 and day 3 after etavopivat administration
V/Fetavopivat: Apparent volume of distribution of etavopivat based on plasma concentration values at single dose and at steady state
Measured as L.
Measured: Day 1 and day 3 after etavopivat administration
CL/Fetavopivat: Apparent plasma clearance of etavopivat at single dose and at steady state
Measured as L/h.
Measured: Day 1 and day 3 after etavopivat administration
C, etavopivat: Observed etavopivat plasma concentration after single and multiple doses
Measured as ng/mL.
Measured: From day 1 to day 4 after administration of etavopivat
Number of adverse events (AEs)
Measured as count of events.
Measured: From first dose (day 1) until end of study (day 32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start6 Feb 2025
- Primary completion27 May 2025
- Study completion27 May 2025
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 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
- NCT06813924
- Sponsor's protocol ID
- NN7535-7976
- Other IDs
- U1111-1309-3456
- Status last verified
- Sep 2026
- First submitted
- 3 Feb 2025
- Last updated
- 29 Sep 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Fixed-Sequence Study to Evaluate the Effect of Etavopivat on the Single-Dose Pharmacokinetics of Midazolam, Digoxin, Rosuvastatin, Pitavastatin, and Metformin in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06813924
- Acronym / sponsor ID
- NN7535-7976
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 7 Feb 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.
The study aims to test if a new medicine called etavopivat potentially affects other medicines in healthy participants. The purpose of the study is to investigate whether the use of etavopivat affects the breakdown and metabolism of commonly used medicines in the body. During the study, participants will receive etavopivat and five different medicines that are already approved and available on the market, and which can be prescribed by doctors. These marketed medicines are called substrate drugs and they are: digoxin, pitavastatin, metformin, midazolam, and rosuvastatin. During a period of the study, participants will take 2 tablets of etavopivat daily for 10 consecutive days. The study will last for about 34 to 64 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Period 1: digoxin+pitavastatin+metformin | Experimental | Drug: Digoxin, Drug: Pitavastatin, Drug: MetforminParticipants will receive a single dose of oral digoxin, pitavastatin and metformin. |
| Period 1: midazolam+rosuvastatin | Experimental | Drug: Midazolam, Drug: RosuvastatinParticipants will receive a single dose of oral midazolam and rosuvastatin. |
| Period 2: etavopivat+midazolam | Experimental | Drug: Etavopivat, Drug: MidazolamParticipants will receive a daily dose of oral etavopivat and single dose of oral midazolam. |
| Period 2: etavopivat+midazolam+rosuvastatin | Experimental | Drug: Etavopivat, Drug: Midazolam, Drug: RosuvastatinParticipants will receive a daily dose of oral etavopivat, single dose of oral midazolam and rosuvastatin. |
| Period 2: etavopivat+digoxin+pitavastatin+metformin | Experimental | Drug: Etavopivat, Drug: Digoxin, Drug: Pitavastatin, Drug: MetforminParticipants will receive a daily dose of oral etavopivat, single dose of oral digoxin, pitavastatin and metformin. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) between 18.5 and 29.9 kilograms per square meter (kg/m^2) (both inclusive) at screening.
- Body weight greater than (>) 50.0 kg at screening.
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Key exclusion criteria (15 listed)
- Known or suspected hypersensitivity to study interventions or related products.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- Exposure to an investigational medicinal product within 30 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before 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, CYP3A4, CYP2C9, MATE1, OATP1B1/1B3, BCRP, OCT2, or P-gp, including St. John's Wort for 28 days prior to dosing and throughout the study.
- Use of any medication with unknown or unspecified content within 90 days before 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 a daily dose of etavopivat orally. | Drug | Period 2: etavopivat+digoxin+pitavastatin+metformin, Period 2: etavopivat+midazolam, Period 2: etavopivat+midazolam+rosuvastatin |
| DigoxinParticipants will receive a single dose of digoxin orally. | Drug | Period 1: digoxin+pitavastatin+metformin, Period 2: etavopivat+digoxin+pitavastatin+metformin |
| PitavastatinParticipants will receive a single dose of pitavastatin orally. | Drug | Period 1: digoxin+pitavastatin+metformin, Period 2: etavopivat+digoxin+pitavastatin+metformin |
| MetforminParticipants will receive a single dose of metformin orally. | Drug | Period 1: digoxin+pitavastatin+metformin, Period 2: etavopivat+digoxin+pitavastatin+metformin |
| MidazolamParticipants will receive a single dose of midazolam orally. | Drug | Period 1: midazolam+rosuvastatin, Period 2: etavopivat+midazolam, Period 2: etavopivat+midazolam+rosuvastatin |
| RosuvastatinParticipants will receive a single dose of rosuvastatin orally. | Drug | Period 1: midazolam+rosuvastatin, Period 2: etavopivat+midazolam+rosuvastatin |
Primary outcome
Cmax, digoxin, SD: Maximum observed digoxin plasma concentration with and without etavopivat at steady state
Time frame: Day 1 and day 3 after digoxin administration
Measured as picograms per milliliter (pg/mL).
AUC0-inf, digoxin, SD: Area under the digoxin plasma concentration-time curve from 0 hours and extrapolated to infinity with and without etavopivat at steady state
Time frame: Day 1 and day 3 after digoxin administration
Measured as hours*picograms per milliliter (h*pg/mL).
Cmax, rosuvastatin, SD: Maximum observed rosuvastatin plasma concentration with and without etavopivat at steady state
Time frame: Day 1 after rosuvastatin administration
Measured as pg/mL.
AUC0-inf, rosuvastatin, SD: Area under the rosuvastatin plasma concentration-time curve from 0 hours and extrapolated to infinity with and without etavopivat at steady state
Time frame: Day 1 after rosuvastatin administration
Measured as h*pg/mL.
Cmax, midazolam, SD: Maximum observed midazolam plasma concentration without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Time frame: Day 1 after midazolam administration
Measured as pg/mL.
AUC0-inf, midazolam, SD: Area under the midazolam plasma concentration-time curve from 0 hours and extrapolated to infinity without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Time frame: Day 1 after midazolam administration
Measured as h*pg/mL.
Cmax, pitavastatin, SD: Maximum observed pitavastatin plasma concentration with and without etavopivat at steady state
Time frame: Day 1 and day 3 after pitavastatin administration
Measured as nanograms per milliliter (ng/mL).
AUC0-inf, pitavastatin, SD: Area under the pitavastatin plasma concentration-time curve from 0 hours and extrapolated to infinity with and without etavopivat at steady state
Time frame: Day 1 and day 3 after pitavastatin administration
Measured as hours*nanograms per milliliter(h*ng/mL).
Cmax, metformin, SD: Maximum observed metformin plasma concentration with and without etavopivat at steady state
Time frame: Day 1 and day 3 after metformin administration
Measured as ng/mL.
AUC0-inf, metformin, SD: Area under the metformin plasma concentration-time curve from 0 hours and extrapolated to infinity with and without etavopivat at steady state
Time frame: Day 1 and day 3 after metformin administration
Measured as h*ng/mL.
43 secondary outcomes
AUC0-last, digoxin, SD: Area under the digoxin plasma concentration-time curve from 0 hours to the last quantifiable concentration with and without etavopivat at steady state
Time frame: Day 1 and day 3 after digoxin administration
t1/2, digoxin, SD: Terminal half-life for digoxin with and without etavopivat at steady state
Time frame: Day 1 and day 3 after digoxin administration
tmax, digoxin, SD: Time to maximum observed digoxin plasma concentration with and without etavopivat at steady state
Time frame: Day 1 and day 3 after digoxin administration
CL/Fdigoxin, SD: Apparent plasma clearance of digoxin with and without etavopivat at steady state
Time frame: Day 1 and day 3 after digoxin administration
Vz/Fdigoxin, SD: Apparent volume of distribution of digoxin with and without etavopivat at steady state based on plasma concentration values
Time frame: Day 1 and day 3 after digoxin administration
AUC0-last, rosuvastatin, SD: Area under the rosuvastatin plasma concentration-time curve from 0 hours to the last quantifiable concentration with and without etavopivat at steady state
Time frame: Day 1 after rosuvastatin administration
t1/2, rosuvastatin, SD: Terminal half-life for rosuvastatin with and without etavopivat at steady state
Time frame: Day 1 after rosuvastatin administration
tmax, rosuvastatin, SD: Time to maximum observed rosuvastatin plasma concentration with and without etavopivat at steady state
Time frame: Day 1 after rosuvastatin administration
CL/Frosuvastatin, SD: Apparent plasma clearance of rosuvastatin with and without etavopivat at steady state
Time frame: Day 1 after rosuvastatin administration
Vz/Frosuvastatin, SD: Apparent volume of distribution of rosuvastatin with and without etavopivat at steady state based on plasma concentration values
Time frame: Day 1 after rosuvastatin administration
AUC0-last, midazolam, SD: Area under the midazolam plasma concentration-time curve from 0 hours to the last quantifiable concentration without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Time frame: Day 1 after midazolam administration
t1/2, midazolam, SD: Terminal half-life for midazolam without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Time frame: Day 1 after midazolam administration
tmax, midazolam, SD: Time to maximum observed midazolam plasma concentration without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Time frame: Day 1 after midazolam administration
CL/Fmidazolam, SD: Apparent plasma clearance of midazolam without etavopivat, with a single dose of etavopivat and with etavopivat at steady state
Time frame: Day 1 after midazolam administration
Vz/Fmidazolam, SD: Apparent volume of distribution of midazolam without etavopivat, with a single dose of etavopivat and with etavopivat at steady state
Time frame: Day 1 after midazolam administration
AUC0-inf, 1-hydroxymidazolam, SD: Area under the midazolam plasma concentration-time curve from 0 hours and extrapolated to infinity without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Time frame: Day 1 after midazolam administration
Cmax, 1-hydroxymidazolam, SD: Maximum observed midazolam plasma concentration without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Time frame: Day 1 after midazolam administration
AUC0-last, 1-hydroxymidazolam, SD: Area under the midazolam plasma concentration-time curve from 0 hours to the last quantifiable concentration without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Time frame: Day 1 after midazolam administration
t1/2, 1-hydroxymidazolam: Terminal half-life for 1-hydroxymidazolam without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Time frame: Day 1 after midazolam administration
tmax, 1-hydroxymidazolam: Time to maximum observed 1-hydroxymidazolam plasma concentration without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Time frame: Day 1 after midazolam administration
CL/F1-hydroxymidazolam: Apparent plasma clearance of 1-hydroxymidazolam without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Time frame: Day 1 after midazolam administration
Vz/F1-hydroxymidazolam: Apparent volume of distribution of 1-hydroxymidazolam based on plasma concentration values without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
Time frame: Day 1 after midazolam administration
AUC0-last, pitavastatin, SD: Area under the pitavastatin plasma concentration-time curve from 0 hours to the last quantifiable concentration with and without etavopivat at steady state
Time frame: Day 1 and day 3 after pitavastatin administration
t1/2, pitavastatin, SD: Terminal half-life for pitavastatin with and without etavopivat at steady state
Time frame: Day 1 and day 3 after pitavastatin administration
tmax, pitavastatin, SD: Time to maximum observed pitavastatin plasma concentration with and without etavopivat at steady state
Time frame: Day 1 and day 3 after pitavastatin administration
CL/Fpitavastatin, SD: Apparent plasma clearance of pitavastatin with and without etavopivat at steady state
Time frame: Day 1 and day 3 after pitavastatin administration
Vz/Fpitavastatin, SD: Apparent volume of distribution of pitavastatin with and without etavopivat at steady state based on plasma concentration values
Time frame: Day 1 and day 3 after pitavastatin administration
AUC0-last, metformin, SD: Area under the metformin plasma concentration-time curve from 0 hours to the last quantifiable concentration with and without etavopivat at steady state
Time frame: Day 1 and day 3 after metformin administration
t1/2, metformin, SD: Terminal half-life for metformin with and without etavopivat at steady state
Time frame: Day 1 and day 3 after metformin administration
tmax, metformin, SD: Time to maximum observed metformin plasma concentration with and without etavopivat at steady state
Time frame: Day 1 and day 3 after metformin administration
CL/Fmetformin, SD: Apparent plasma clearance of metformin with and without etavopivat at steady state
Time frame: Day 1 and day 3 after metformin administration
Vz/Fmetformin, SD: Apparent volume of distribution of metformin with and without etavopivat at steady state based on plasma concentration values
Time frame: Day 1 and day 3 after metformin administration
Aelast, metformin, SD%: Percentage of the metformin excreted into urine from the time of dosing to the collection time of the last measurable concentration with and without etavopivat at steady state
Time frame: Day 1 and day 3 after metformin administration
CLR, metformin, SD: Renal clearance of metformin
Time frame: Day 1 and day 3 after metformin administration
AUC0-tau, etavopivat: Area under the etavopivat plasma concentration-time curve during one dosing interval at single dose and at steady state
Time frame: Day 1 and day 3 after etavopivat administration
AUC0-last etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours to the last quantifiable concentration at single dose and at steady state
Time frame: Day 1 and day 3 after etavopivat administration
Cmax, etavopivat: Maximum observed etavopivat plasma concentration at single dose and at steady state
Time frame: Day 1 and day 3 after etavopivat administration
t1/2, etavopivat: Terminal half-life for etavopivat at single dose and at steady state
Time frame: Day 1 and day 3 after etavopivat administration
tmax, etavopivat: Time to maximum observed etavopivat plasma concentration at single dose and at steady state
Time frame: Day 1 and day 3 after etavopivat administration
V/Fetavopivat: Apparent volume of distribution of etavopivat based on plasma concentration values at single dose and at steady state
Time frame: Day 1 and day 3 after etavopivat administration
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 Sep 2026.
- 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, Digoxin and Pitavastatin 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 3 inclusion and 15 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 Sep 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. 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?
Cmax, digoxin, SD: Maximum observed digoxin plasma concentration with and without etavopivat at steady state (time frame: Day 1 and day 3 after digoxin administration). The study lists 10 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 Sep 2026.