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

NCT ID: NCT06581627

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-26
• Study Completion Date: 2024-10-31

Brief Summary

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.

Conditions

Healthy Volunteers; Sickle Cell Disease; Thalassemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Etavopivat

Participants will be administered a single dose of 2 tablets of etavopivat together.

Group Type: EXPERIMENTAL

Etavopivat

Intervention Type: DRUG

2 tablets of Etavopivat will be administered in fasted state via oral route

Interventions

Etavopivat

2 tablets of Etavopivat will be administered in fasted state via oral route

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency '(dept. 2834)'

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Beijing Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

U1111-1294-7463

Identifier Type: OTHER

Identifier Source: secondary_id

NN7535-7704

Identifier Type: -

Identifier Source: org_study_id