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

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).

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers Sickle Cell Disease, Thalassemia
• Intervention / Treatment: Drug: Etavopivat

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • ICON-Salt Lake City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1: Etavopivat: fed-fasted; Participants will receive a single dose of Etavopivat in fed condition in period 1 and a single dose of Etavopivat in fasted condition in period 2.	Drug: Etavopivat; Participants will receive single dose of oral Etavopivat in each treatment period.
Experimental: Sequence 2: Etavopivat: fasted-fed; Participants will receive a single dose of Etavopivat in fasted condition in period 1 and a single dose of Etavopivat in fed condition in period 2.	Drug: Etavopivat; Participants will receive single dose of oral Etavopivat in each treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-inf, etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose	Measured as hours nanograms per milliliter (h*ng/mL).	From 0 to 120 hours after IMP administration (V2/V6)
Cmax, etavopivat: Maximum observed etavopivat plasma concentration after a single dose	Measured as nanograms per milliliter (ng/mL).	From 0 to 120 hours after IMP administration (V2/V6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-last, etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours to the time of last quantifiable concentration	Measured as hours nanograms per milliliter (h*ng/ml).	From 0 to 120 hours after IMP administration (V2/V6)
tmax, etavopivat: Time to maximum observed etavopivat plasma concentration after a single dose	Measured as hours.	From 0 to 120 hours after IMP administration (V2/V6)
t1/2, etavopivat: Terminal half-life for etavopivat after a single dose	Measured as hours.	From 0 to 120 hours after IMP administration (V2/V6)
CL/Fetavopivat: Apparent plasma clearance of etavopivat after a single dose	Measured as liter per hours (L/h).	From 0 to 120 hours after IMP administration (V2/V6)
Vz/Fetavopivat: Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values	Measured as liters (L).	From 0 to 120 hours after IMP administration (V2/V6)
Number of adverse events	Measured as count of events.	From IMP administration on day 1 to completion of the end of study visit (V10)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2024
• Primary Completion (Actual): July 6, 2024
• Study Completion (Actual): July 8, 2024

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Estimated): October 10, 2025
• Last Update Submitted That Met QC Criteria: October 9, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Thalassemia
• Other Study ID Numbers: NN7535-7702; U1111-1289-2544 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No