A Research Study of the Effect of Food on Etavopivat in Healthy Participants

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers Sickle Cell Disease, Thalassemia

Treatments: Drug: Etavopivat

Study type: Interventional

Funder types: Industry

Identifiers

NCT06433661

U1111-1289-2544 (Other Identifier)

NN7535-7702

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of food on the amount of etavopivat in the bloodstream of healthy participants. Participants will take a single oral dose of etavopivat following a high-fat meal (i.e. fed) and on an empty stomach (i.e fasted) on two separate occasions.The study will last up to 50 days (including screening).

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female.
• Age 18-55 years (both inclusive) at the time of signing the informed consent.
• Body mass index (BMI) between 18.5 and 39.9 kilogram per meter square (kg/m^2) (both inclusive) at screening.
• Body weight greater than or equal to (≥) 40.0 kilogram (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 30 days or 5 times the half-life of the previous investigational medicinal 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 tobacco and nicotine products, defined as any of the below:
• Has used any product containing tobacco or nicotine within 90 days prior to screening,
• Unable or unwilling to refrain from the use of any product containing tobacco or nicotine throughout the study,
• Positive nicotine test at screening.
• Participant is unable to refrain from or anticipates the use of any drug known to be a moderate or strong inhibitor or inducer of uridine 5'-diphospho-glucuronosyltransferase (UGT) enzymes, cytochrome P450 (CYP) 3A4, CYP2C9 or permeability glycoprotein (P-gp), including St. John's Wort, for 28 days prior to dosing and throughout the study.
• Participant is unable to refrain from or anticipate the use of any medications or substances prohibited in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

16 participants in 2 patient groups

Sequence 1: Etavopivat: fed-fasted

Experimental group

Description:

Participants will receive a single dose of Etavopivat in fed condition in period 1 and a single dose of Etavopivat in fasted condition in period 2.

Treatment:

Drug: Etavopivat

Sequence 2: Etavopivat: fasted-fed

Experimental group

Description:

Participants will receive a single dose of Etavopivat in fasted condition in period 1 and a single dose of Etavopivat in fed condition in period 2.

Treatment:

Drug: Etavopivat