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

NCT06433661 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN7535-7702U1111-1289-2544
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy Volunteers Sickle Cell Disease, Thalassemia

Outcome Measures

Primary Outcomes (2)

• AUC0-inf, etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose

  Measured as hours nanograms per milliliter (h\*ng/mL).

  From 0 to 120 hours after IMP administration (V2/V6)

• Cmax, etavopivat: Maximum observed etavopivat plasma concentration after a single dose

  Measured as nanograms per milliliter (ng/mL).

  From 0 to 120 hours after IMP administration (V2/V6)

Secondary Outcomes (6)

• AUC0-last, etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours to the time of last quantifiable concentration

  From 0 to 120 hours after IMP administration (V2/V6)

• tmax, etavopivat: Time to maximum observed etavopivat plasma concentration after a single dose

  From 0 to 120 hours after IMP administration (V2/V6)

• t1/2, etavopivat: Terminal half-life for etavopivat after a single dose

  From 0 to 120 hours after IMP administration (V2/V6)

• CL/Fetavopivat: Apparent plasma clearance of etavopivat after a single dose

  From 0 to 120 hours after IMP administration (V2/V6)

• Vz/Fetavopivat: Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values

  From 0 to 120 hours after IMP administration (V2/V6)

Study Arms (2)

Sequence 1: Etavopivat: fed-fasted

EXPERIMENTAL

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.

Drug: Etavopivat

Sequence 2: Etavopivat: fasted-fed

EXPERIMENTAL

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.

Drug: Etavopivat

Interventions

Etavopivat DRUG

Participants will receive single dose of oral Etavopivat in each treatment period.

Sequence 1: Etavopivat: fed-fasted; Sequence 2: Etavopivat: fasted-fed

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

ICON-Salt Lake City

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Thalassemia

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 30, 2024
• Study Start: May 28, 2024
• Primary Completion: July 6, 2024
• Study Completion: July 8, 2024
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)