Status:
COMPLETED
A Research Study Looking at a Single Dose of Etavopivat in Healthy Chinese Participants
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Healthy Volunteers
Sickle Cell Disease
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06581627
Start Date
August 26 2024
End Date
October 31 2024
Last Update
December 29 2025
Active Locations (1)
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1
Beijing Hospital
Beijing, Beijing Municipality, China, 100730