NCT06813924CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 37 (actual)
- First submitted
- 3 Feb 2025
- Start date
- 6 Feb 2025
- Primary completion date
- 27 May 2025
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Sickle cell disease, Thalassaemia
- NCT number
- NCT06813924
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 37
- From 6 Feb 2025 to the primary completion date, 27 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
- Hormone replacement therapy (HRT) (for menopausal females).
- Over-the-counter topical medications known to not reach systemic circulation.
- Abstaining from concomitant medication not allowed during the study.
Other illness
- Known or suspected hypersensitivity to study interventions or related products.
Other
- 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.
- Adequate contraceptive methods.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ICON-Salt Lake City Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.