Investigating how etavopivat affects other medications in healthy individuals

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

This study tests how the medication etavopivat affects the way the body processes five common drugs in healthy people.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Novo Nordisk A/S (Industry-sponsored)
• Locations: 1 site (Salt Lake City, Utah)
• Trial ID: NCT06813924 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of etavopivat on the metabolism of commonly prescribed medications in healthy participants. Participants will take etavopivat alongside five approved drugs—digoxin, pitavastatin, metformin, midazolam, and rosuvastatin—over a period of 10 days. The goal is to understand how etavopivat influences the breakdown of these medications in the body. The overall duration of the study will be between 34 to 64 days.

Who should consider this trial

Good fit: Ideal candidates are healthy adults with a BMI between 18.5 and 29.9 kg/m² and a body weight greater than 50 kg.

Not a fit: Patients with known hypersensitivity to the study medications or those who are pregnant or breastfeeding will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the safety and efficacy of drug combinations involving etavopivat for patients with conditions like sickle cell disease and thalassemia.

How similar studies have performed: While this specific approach is novel, similar studies assessing drug interactions have shown varying degrees of success.

Eligibility criteria

Inclusion Criteria:

* Body mass index (BMI) between 18.5 and 29.9 kilograms per square meter (kg/m\^2) (both inclusive) at screening.
* Body weight greater than (\>) 50.0 kg at screening.
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Known or suspected hypersensitivity to study interventions or related products.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
* Exposure to an investigational medicinal product within 30 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
* Participant is unable to refrain from or anticipates the use of any drug known to be a moderate or strong inhibitor or inducer of uridine 5'-diphospho-glucuronosyltransferase (UGT) enzymes, CYP3A4, CYP2C9, MATE1, OATP1B1/1B3, BCRP, OCT2, or P-gp, including St. John's Wort for 28 days prior to dosing and throughout the study.
* Use of any medication with unknown or unspecified content within 90 days before screening.
* Use of or intent to use prescription medicinal products or non-prescription drugs (including vitamins and herbal supplements) within 14 days prior to dosing and throughout the study, as declared by the participant, except for:
* Adequate contraceptive methods.
* Hormone replacement therapy (HRT) (for menopausal females).
* Over-the-counter topical medications known to not reach systemic circulation.
* Occasional use of acetaminophen up to 2 grams (g) (4 x 0.5 g) daily.
* Not able or not willing to adhere to study procedures, including:
* Eating the food provided in the study.
* Refraining from ingesting food or drinks that are not allowed during the study.
* Swallowing tablets.
* Abstaining from concomitant medication not allowed during the study.

Where this trial is running

Salt Lake City, Utah

• ICON-Salt Lake City — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Study coordinator: Novo Nordisk

Conditions Healthy Volunteers Sickle Cell Disease, Thalassemia