COMPLETED

A Research Study of the Effect of Etavopivat on Other Drugs in Healthy Participants

Conditions

Healthy Volunteers Sickle Cell Disease, Thalassemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study aims to test if a new medicine called etavopivat potentially affects other medicines in healthy participants. The purpose of the study is to investigate whether the use of etavopivat affects the breakdown and metabolism of commonly used medicines in the body. During the study, participants will receive etavopivat and five different medicines that are already approved and available on the market, and which can be prescribed by doctors. These marketed medicines are called substrate drugs and they are: digoxin, pitavastatin, metformin, midazolam, and rosuvastatin. During a period of the study, participants will take 2 tablets of etavopivat daily for 10 consecutive days. The study will last for about 34 to 64 days.

Official Title

An Open-Label, Fixed-Sequence Study to Evaluate the Effect of Etavopivat on the Single-Dose Pharmacokinetics of Midazolam, Digoxin, Rosuvastatin, Pitavastatin, and Metformin in Healthy Adult Participants

Quick Facts

Study Start:2025-02-06

Study Completion:2025-05-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06813924

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Body mass index (BMI) between 18.5 and 29.9 kilograms per square meter (kg/m\^2) (both inclusive) at screening. * Body weight greater than (\>) 50.0 kg at screening. * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.	* Known or suspected hypersensitivity to study interventions or related products. * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method. * Exposure to an investigational medicinal product within 30 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before 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, CYP3A4, CYP2C9, MATE1, OATP1B1/1B3, BCRP, OCT2, or P-gp, including St. John's Wort for 28 days prior to dosing and throughout the study. * Use of any medication with unknown or unspecified content within 90 days before screening. * Use of or intent to use prescription medicinal products or non-prescription drugs (including vitamins and herbal supplements) within 14 days prior to dosing and throughout the study, as declared by the participant, except for: * Adequate contraceptive methods. * Hormone replacement therapy (HRT) (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. * Not able or not willing to adhere to study procedures, including: * Eating the food provided in the study. * Refraining from ingesting food or drinks that are not allowed during the study. * Swallowing tablets. * Abstaining from concomitant medication not allowed during the study.

Inclusion Criteria

Exclusion Criteria

* Body mass index (BMI) between 18.5 and 29.9 kilograms per square meter (kg/m\^2) (both inclusive) at screening.
* Body weight greater than (\>) 50.0 kg at screening.
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

* Known or suspected hypersensitivity to study interventions or related products.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
* Exposure to an investigational medicinal product within 30 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before 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, CYP3A4, CYP2C9, MATE1, OATP1B1/1B3, BCRP, OCT2, or P-gp, including St. John's Wort for 28 days prior to dosing and throughout the study.
* Use of any medication with unknown or unspecified content within 90 days before screening.
* Use of or intent to use prescription medicinal products or non-prescription drugs (including vitamins and herbal supplements) within 14 days prior to dosing and throughout the study, as declared by the participant, except for:
* Adequate contraceptive methods.
* Hormone replacement therapy (HRT) (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.
* Not able or not willing to adhere to study procedures, including:
* Eating the food provided in the study.
* Refraining from ingesting food or drinks that are not allowed during the study.
* Swallowing tablets.
* Abstaining from concomitant medication not allowed during the study.

Contacts and Locations

Principal Investigator

Clinical Transparency (dept. 2834)

STUDY_DIRECTOR

Novo Nordisk A/S

Study Locations (Sites)

ICON-Salt Lake City

Salt Lake City, Utah, 84124

United States

Collaborators and Investigators

Sponsor: Novo Nordisk A/S

Clinical Transparency (dept. 2834), STUDY_DIRECTOR, Novo Nordisk A/S

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-06

Study Completion Date2025-05-27

Study Record Updates

Study Start Date2025-02-06

Study Completion Date2025-05-27

Terms related to this study

Additional Relevant MeSH Terms

Healthy Volunteers Sickle Cell Disease, Thalassemia