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A Research Study of the Effect of Etavopivat on Other Drugs in Healthy Participants
Sponsor: Novo Nordisk A/S
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. 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.
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
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
37
Start Date
2025-02-06
Completion Date
2025-05-27
Last Updated
2026-09-29
Healthy Volunteers
Yes
Interventions
Etavopivat
Participants will receive a daily dose of etavopivat orally.
Digoxin
Participants will receive a single dose of digoxin orally.
Pitavastatin
Participants will receive a single dose of pitavastatin orally.
Metformin
Participants will receive a single dose of metformin orally.
Midazolam
Participants will receive a single dose of midazolam orally.
Rosuvastatin
Participants will receive a single dose of rosuvastatin orally.
Locations (1)
ICON-Salt Lake City
Salt Lake City, Utah, United States