ICON-Salt Lake City
Salt Lake City, Utah, 84124, United States
NCT Number: NCT06813924
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Salt Lake City, Utah, 84124, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive a daily dose of etavopivat orally.
Participants will receive a single dose of digoxin orally.
Participants will receive a single dose of pitavastatin orally.
Participants will receive a single dose of metformin orally.
Participants will receive a single dose of midazolam orally.
Participants will receive a single dose of rosuvastatin orally.
Time frame: Day 1 and day 3 after digoxin administration
Measured as picograms per milliliter (pg/mL).
Time frame: Day 1 and day 3 after digoxin administration
Measured as hours*picograms per milliliter (h*pg/mL).
Time frame: Day 1 after rosuvastatin administration
Measured as pg/mL.
Time frame: Day 1 after rosuvastatin administration
Measured as h*pg/mL.
Time frame: Day 1 after midazolam administration
Measured as pg/mL.
Time frame: Day 1 after midazolam administration
Measured as h*pg/mL.
Time frame: Day 1 and day 3 after pitavastatin administration
Measured as nanograms per milliliter (ng/mL).
Time frame: Day 1 and day 3 after pitavastatin administration
Measured as hours*nanograms per milliliter(h*ng/mL).
Time frame: Day 1 and day 3 after metformin administration
Measured as ng/mL.
Time frame: Day 1 and day 3 after metformin administration
Measured as h*ng/mL.
Time frame: Day 1 and day 3 after digoxin administration
Measured as h*pg/mL.
Time frame: Day 1 and day 3 after digoxin administration
Measured as hours.
Time frame: Day 1 and day 3 after digoxin administration
Measured as hours.
Time frame: Day 1 and day 3 after digoxin administration
Measured as liters per hour (L/h).
Time frame: Day 1 and day 3 after digoxin administration
Measured as liters (L).
Time frame: Day 1 after rosuvastatin administration
Measured as h*pg/mL.
Time frame: Day 1 after rosuvastatin administration
Measured as hours.
Time frame: Day 1 after rosuvastatin administration
Measured as hours.
Time frame: Day 1 after rosuvastatin administration
Measured as L/h.
Time frame: Day 1 after rosuvastatin administration
Measured as L.
Time frame: Day 1 after midazolam administration
Measured as h*pg/mL.
Time frame: Day 1 after midazolam administration
Measured as hours.
Time frame: Day 1 after midazolam administration
Measured as hours.
Time frame: Day 1 after midazolam administration
Measured as L/h.
Time frame: Day 1 after midazolam administration
Measured as L.
Time frame: Day 1 after midazolam administration
Measured as h*pg/mL.
Time frame: Day 1 after midazolam administration
Measured as pg/mL.
Time frame: Day 1 after midazolam administration
Measured as h*pg/mL.
Time frame: Day 1 after midazolam administration
Measured as hours.
Time frame: Day 1 after midazolam administration
Measured as hours.
Time frame: Day 1 after midazolam administration
Measured as L/h.
Time frame: Day 1 after midazolam administration
Measured as L.
Time frame: Day 1 and day 3 after pitavastatin administration
Measured as h*ng/mL.
Time frame: Day 1 and day 3 after pitavastatin administration
Measured as hours.
Time frame: Day 1 and day 3 after pitavastatin administration
Measured as hours.
Time frame: Day 1 and day 3 after pitavastatin administration
Measured as L/h.
Time frame: Day 1 and day 3 after pitavastatin administration
Measured as L.
Time frame: Day 1 and day 3 after metformin administration
Measured as h*ng/mL.
Time frame: Day 1 and day 3 after metformin administration
Measured as hours.
Time frame: Day 1 and day 3 after metformin administration
Measured as hours.
Time frame: Day 1 and day 3 after metformin administration
Measured as L/h.
Time frame: Day 1 and day 3 after metformin administration
Measured as L.
Time frame: Day 1 and day 3 after metformin administration
Measured as percentage (%) of the metformin excreted into urine.
Time frame: Day 1 and day 3 after metformin administration
Measured as L/h.
Time frame: Day 1 and day 3 after etavopivat administration
Measured as h*ng/mL.
Time frame: Day 1 and day 3 after etavopivat administration
Measured as h*ng/mL.
Time frame: Day 1 and day 3 after etavopivat administration
Measured as ng/mL.
Time frame: Day 1 and day 3 after etavopivat administration
Measured as hours.
Time frame: Day 1 and day 3 after etavopivat administration
Measured as hours.
Time frame: Day 1 and day 3 after etavopivat administration
Measured as L.
Time frame: Day 1 and day 3 after etavopivat administration
Measured as L/h.
Time frame: From day 1 to day 4 after administration of etavopivat
Measured as ng/mL.
Time frame: From first dose (day 1) until end of study (day 32)
Measured as count of events.
Novo Nordisk A/S
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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