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

NCT06813924 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-09-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (dept. 2834) · Novo Nordisk A/S

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-06
Primary Completion
2025-05-27
Completion
2025-05-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06813924 on ClinicalTrials.gov