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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Thalassemia

Sickle Cell Disease

Treatments

Drug: Etavopivat

Study type

Interventional

Funder types

Industry

Identifiers

NCT06581627

U1111-1294-7463 (Other Identifier)

NN7535-7704

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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