NCT06813924

A Research Study of the Effect of Etavopivat on Other Drugs in Healthy Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers Sickle Cell Disease, Thalassemia

Interventions

Type	Name	Description
DRUG	Etavopivat	Participants will receive a daily dose of etavopivat orally.
DRUG	Digoxin	Participants will receive a single dose of digoxin orally.
DRUG	Pitavastatin	Participants will receive a single dose of pitavastatin orally.
DRUG	Metformin	Participants will receive a single dose of metformin orally.
DRUG	Midazolam	Participants will receive a single dose of midazolam orally.
DRUG	Rosuvastatin	Participants will receive a single dose of rosuvastatin orally.

Timeline

• Start date: 2025-02-06
• Primary completion: 2025-05-27
• Completion: 2025-05-27
• First posted: 2025-02-07
• Last updated: 2025-09-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study