NCT06581627CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 29 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 30 Aug 2024
- Start date
- 26 Aug 2024
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Sickle cell disease, Thalassaemia
- NCT number
- NCT06581627
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 24
- From 26 Aug 2024 to the primary completion date, 31 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Any disorder, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.