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

Korábbi kezelés

• 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.
• 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:
• Hormone replacement therapy (for menopausal females)
• Over-the-counter topical medications known to not reach systemic circulation
• 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
• Has used any product containing tobacco or nicotine within 90 days prior to screening

Más betegség

• Any disorder, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.

Egyéb

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods.
• Acceptable contraceptive methods
• 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
• Use of tobacco and nicotine products, defined as any of the following:
• Not willing to refrain from the use of any product containing tobacco or nicotine throughout the study
• Positive nicotine test at screening

• 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.