A Research Study Looking at a Single Dose of Etavopivat in Healthy Chinese Participants

A Single-centre, Open-label, Single-group Study Investigating the Pharmacokinetics, Safety and Tolerability After a Single Dose of Oral Etavopivat in Healthy Chinese Participants

The study tests a new medicine called etavopivat in healthy Chinese participants. During the study, the participant will be given 1 dose of the study medicine. A dose is 2 tablets which are swallowed together with a cup of water. The study doctor will measure how much of the study medicine is in the blood as time passes. After the dose is given, the study will last for 7 to 9 days. The participants will attend a screening visit 2 to 28 days before they are given the study medicine. The participant will have 6 clinic visits in total. As part of the study, participant will stay overnight at the clinic for 3 nights. In some cases the doctor may decide that participant need to stay more nights. Participant will have blood tests and other health assessments at all 6 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If the participant do take part in the study, participant will need to refrain from certain activities and behaviours for up to 3 months before taking the study medicine. Participant will also need to go without food and drinks other than water in the 10 hours before and 4 hours after taking the medicine.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Beijing Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Male or female Chinese participants.
• Age 18-45 years (both inclusive) at the time of signing the informed consent form.
• Body mass index (BMI) between 18.0 and 33.0 kg/m^2 (both inclusive) at screening.
• Body weight greater than or equal to 40.0 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 90 days or 5 times the half-life of the previous investigational medical 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 any medication with unknown or unspecified content within 90 days before screening.
• Use of prescription medicinal products or non-prescription drugs (including Chinese traditional medicine or local medicine) within 14 days before screening, as declared by the participant, apart from:
• Acceptable contraceptive methods
• Hormone replacement therapy (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
• Ibuprofen up to 2.4 g (4 x 0.6 g) daily
• Acetylsalicylic acid up to 2.4 g (4 x 0.6 g) daily
• Is unable to refrain from or anticipates the use of any drug known to be a strong or moderate inhibitor or inducer of uridine 5'-diphospho glucuronosyltransferase (UGT) enzymes, cytochrome P450 (CYP) 3A4, CYP2C9 or permeability glycoproteins (P-gp), including St. John's Wort, for 28 days prior to dosing and throughout the study
• Is unable to refrain from or anticipates the use of any medications or substances prohibited in the study
• Use of tobacco and nicotine products, defined as any of the following:
• Has used any product containing tobacco or nicotine within 90 days prior to screening
• Not willing to refrain from the use of any product containing tobacco or nicotine throughout the study
• Positive nicotine test at screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Etavopivat; Participants will be administered a single dose of 2 tablets of etavopivat together.	Drug: Etavopivat; 2 tablets of Etavopivat will be administered in fasted state via oral route

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 in hour*nanogram/millilitre (h*ng/mL).	From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Cmax,etavopivat: Maximum observed etavopivat plasma concentration after a single dose	Measured in nanograms/millilitre (ng/mL).	From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Weight-adjusted AUC0-inf,etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose divided by body weight	Measured in(hour*nanogram/millilitre)/kilograms ((h*ng/mL)/kg).	From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Weight-adjusted Cmax,etavopivat: Maximum observed etavopivat plasma concentration after a single dose divided by body weight	Measured in (nanograms/millilitre )/kilogram ((ng/mL)/kg).	From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
AUC0-last,etavopivat: Area under the etavopivat plasma concentration-time curve from0 hours to the time of last quantifiable concentration	Measured in hour*nanogram/millilitre (h*ng/mL).	From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
tmax,etavopivat: Time to maximum observed etavopivat plasma concentration after a single dose	Measured in hour (h).	From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
t½,etavopivat: Terminal half-life for etavopivat after a single dose	Measured in hour (h).	From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
CL/F etavopivat: Apparent plasma clearance of etavopivat after a single dose	Measured in Litre/hour (L/h).	From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)
Vz/F etavopivat: Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values	Measure in litre (L).	From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	Measured as count.	From dosing (day 1) to end of study (day 7 to 9)

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): August 26, 2024
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 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; Anemia, Sickle Cell; Thalassemia
• Other Study ID Numbers: NN7535-7704; U1111-1294-7463 (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: No
• Studies a U.S. FDA-regulated device product: No