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

Sponsor
Novo Nordisk A/S
Study ID
NCT06581627
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 26, 2024
Status verified
Dec 2025
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Etavopivat
    Participants will be administered a single dose of 2 tablets of etavopivat together.

Primary Outcome Measure

AUC0-inf,etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose [ Time Frame: From 0 to 120 hours after investigational medicinal product (IMP) administration (day 6) ]

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