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NCT06433661CompletedPhase 1

A Research Study of the Effect of Food on Etavopivat in Healthy Participants

A Single-centre, Open-label, Randomised, Single-dose, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Etavopivat in Healthy Participants

Source: ClinicalTrials.gov · Last updated 10 Oct 2025

Brief summary (registry, in English)

The purpose of this study is to evaluate the effect of food on the amount of etavopivat in the bloodstream of healthy participants. Participants will take a single oral dose of etavopivat following a high-fat meal (i.e. fed) and on an empty stomach (i.e fasted) on two separate occasions.The study will last up to 50 days (including screening).

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
16 (actual)
First submitted
22 May 2024
Start date
28 May 2024
Primary completion date
6 Jul 2024
Lead sponsor
Novo Nordisk A/S
NCT number
NCT06433661

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 16
  • From 28 May 2024 to the primary completion date, 6 Jul 2024
  • 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

  • Participation (i.e., signed informed consent) in any other interventional clinical study within 30 days or 5 times the half-life of the previous investigational medicinal product (IMP) (if known), whichever is longer before screening.
  • Has used any product containing tobacco or nicotine within 90 days prior to 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, cytochrome P450 (CYP) 3A4, CYP2C9 or permeability glycoprotein (P-gp), including St. John's Wort, for 28 days prior to dosing and throughout the study.
  • Participant is unable to refrain from or anticipate the use of any medications or substances prohibited in the study.

Other illness

  • Any disorder, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.

Other

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods.
  • Use of tobacco and nicotine products, defined as any of the below:
  • Unable or unwilling to refrain from the use of any product containing tobacco or nicotine throughout the study,
  • Positive nicotine test at screening.

Who the study is looking for

  • Male or female.
  • Age 18-55 years (both inclusive) at the time of signing the informed consent.
  • Body mass index (BMI) between 18.5 and 39.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening.
  • Body weight greater than or equal to (≥) 40.0 kilogram (kg) at screening.
  • Considered to be generally healthy based on the medical history, physical examination and the results of vital signs, electrocardiogram (ECG) 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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ICON-Salt Lake City
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.