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Completed

NCT Number: NCT06433661

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

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).

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON-Salt Lake City

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods.
  • 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.
  • Any disorder, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
  • Use of tobacco and nicotine products, defined as any of the below:
  • Has used any product containing tobacco or nicotine within 90 days prior to screening,
  • Unable or unwilling to refrain from the use of any product containing tobacco or nicotine throughout the study,
  • Positive nicotine test at 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.

Treatment and study plan

Etavopivat

Drug

Participants will receive single dose of oral Etavopivat in each treatment period.

Primary outcomes

  1. AUC0-inf, etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose

    Time frame: From 0 to 120 hours after IMP administration (V2/V6)

    Measured as hours nanograms per milliliter (h*ng/mL).

  2. Cmax, etavopivat: Maximum observed etavopivat plasma concentration after a single dose

    Time frame: From 0 to 120 hours after IMP administration (V2/V6)

    Measured as nanograms per milliliter (ng/mL).

Secondary outcomes

  1. AUC0-last, etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours to the time of last quantifiable concentration

    Time frame: From 0 to 120 hours after IMP administration (V2/V6)

    Measured as hours nanograms per milliliter (h*ng/ml).

  2. tmax, etavopivat: Time to maximum observed etavopivat plasma concentration after a single dose

    Time frame: From 0 to 120 hours after IMP administration (V2/V6)

    Measured as hours.

  3. t1/2, etavopivat: Terminal half-life for etavopivat after a single dose

    Time frame: From 0 to 120 hours after IMP administration (V2/V6)

    Measured as hours.

  4. CL/Fetavopivat: Apparent plasma clearance of etavopivat after a single dose

    Time frame: From 0 to 120 hours after IMP administration (V2/V6)

    Measured as liter per hours (L/h).

  5. Vz/Fetavopivat: Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values

    Time frame: From 0 to 120 hours after IMP administration (V2/V6)

    Measured as liters (L).

  6. Number of adverse events

    Time frame: From IMP administration on day 1 to completion of the end of study visit (V10)

    Measured as count of events.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 30, 2024
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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