Etavopivat for Sickle Cell Disease

Overseen By Novo Nordisk

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Novo Nordisk A/S

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

This study is for healthy individuals who may help researchers understand if a new medicine, etavopivat, affects how the body processes other common drugs. Participants should not have sickle cell disease or thalassemia but will contribute to research that could benefit those conditions.

Inclusion Criteria

My weight is over 50 kg.

Considered to be generally healthy based on medical history, physical examination, and results of vital signs, electrocardiogram, and clinical laboratory tests performed during the screening visit, as judged by the investigator

Body mass index (BMI) between 18.5 and 29.9 kilograms per square meter (kg/m^2) at screening

Exclusion Criteria

Known or suspected hypersensitivity to study interventions or related products

I am willing and able to follow all study rules, including diet and medication restrictions.

I can avoid taking certain strong medications and St. John's Wort for 28 days before and during the study.

Treatment Details

Interventions

• Etavopivat (Other)

Trial Overview The trial tests whether etavopivat changes how the body breaks down and uses five approved medicines: digoxin (heart medication), pitavastatin and rosuvastatin (cholesterol medications), metformin (diabetes medication), and midazolam (sedative). Participants take etavopivat with these drugs over 10 days.

Participant Groups

Group I: Period 2: etavopivat+midazolam+rosuvastatin Experimental Treatment 3 Interventions

Participants will receive a daily dose of oral etavopivat, single dose of oral midazolam and rosuvastatin.

Group II: Period 2: etavopivat+midazolam Experimental Treatment 2 Interventions

Participants will receive a daily dose of oral etavopivat and single dose of oral midazolam.

Group III: Period 2: etavopivat+digoxin+pitavastatin+metformin Experimental Treatment 4 Interventions

Participants will receive a daily dose of oral etavopivat, single dose of oral digoxin, pitavastatin and metformin.

Group IV: Period 1: midazolam+rosuvastatin Experimental Treatment 2 Interventions

Participants will receive a single dose of oral midazolam and rosuvastatin.

Group V: Period 1: digoxin+pitavastatin+metformin Experimental Treatment 3 Interventions

Participants will receive a single dose of oral digoxin, pitavastatin and metformin.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen