## Protocol Section
### Identification Module
**NCT ID:** NCT06433661

**Brief Title:** A Research Study of the Effect of Food on Etavopivat in Healthy Participants

**Official Title:** A Single-centre, Open-label, Randomised, Single-dose, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Etavopivat in Healthy Participants

#### Organization Study ID Info
**ID:** NN7535-7702
#### Organization
**Class:** INDUSTRY
**Full Name:** Novo Nordisk A/S
#### Secondary ID Infos
**Domain:** World Health Organization (WHO)
**ID:** U1111-1289-2544
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-07-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-07-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-28

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Novo Nordisk A/S

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Healthy Volunteers Sickle Cell Disease, Thalassemia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 16

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Drug: Etavopivat

**Label:** Sequence 1: Etavopivat: fed-fasted

**Type:** EXPERIMENTAL

#### Arm Group 2

**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.

**Intervention Names:**

- Drug: Etavopivat

**Label:** Sequence 2: Etavopivat: fasted-fed

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Sequence 1: Etavopivat: fed-fasted

- Sequence 2: Etavopivat: fasted-fed

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

**Name:** Etavopivat

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

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

**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 IMP administration (V2/V6)

**Description:** Measured as nanograms per milliliter (ng/mL).

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

**Time Frame:** From 0 to 120 hours after IMP administration (V2/V6)

#### Secondary Outcomes

**Description:** Measured as hours nanograms per milliliter (h\*ng/ml).

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

**Time Frame:** From 0 to 120 hours after IMP administration (V2/V6)

**Description:** Measured as hours.

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

**Time Frame:** From 0 to 120 hours after IMP administration (V2/V6)

**Description:** Measured as hours.

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

**Time Frame:** From 0 to 120 hours after IMP administration (V2/V6)

**Description:** Measured as liter per hours (L/h).

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

**Time Frame:** From 0 to 120 hours after IMP administration (V2/V6)

**Description:** Measured as liters (L).

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

**Time Frame:** From 0 to 120 hours after IMP administration (V2/V6)

**Description:** Measured as count of events.

**Measure:** Number of adverse events

**Time Frame:** From IMP administration on day 1 to completion of the end of study visit (V10)

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clinicaltrials@novonordisk.com

**Name:** Novo Nordisk

**Phone:** (+1) 866-867-7178

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Salt Lake City

**Country:** United States

**Facility:** ICON-Salt Lake City

**State:** Utah

**Zip:** 84124

#### Overall Officials

**Official 1:**

**Affiliation:** Novo Nordisk A/S

**Name:** Clinical Transparency (dept. 2834)

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

**IPD Sharing:** YES

**URL:** http://novonordisk-trials.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000000745

- Term: Anemia, Hemolytic, Congenital

- ID: D000000743

- Term: Anemia, Hemolytic

- ID: D000000740

- Term: Anemia

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000006453

- Term: Hemoglobinopathies

- ID: D000030342

- Term: Genetic Diseases, Inborn

### Condition Browse Module - Browse Branches

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4085

- Name: Anemia, Sickle Cell

- Relevance: HIGH

- As Found: Sickle Cell Disease

- ID: M16557

- Name: Thalassemia

- Relevance: HIGH

- As Found: Thalassemia

- ID: M4070

- Name: Anemia

- Relevance: LOW

- As Found: Unknown

- ID: M9547

- Name: Hemolysis

- Relevance: LOW

- As Found: Unknown

- ID: M4073

- Name: Anemia, Hemolytic

- Relevance: LOW

- As Found: Unknown

- ID: M4075

- Name: Anemia, Hemolytic, Congenital

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9539

- Name: Hemoglobinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: T5622

- Name: Thalassemia

- Relevance: HIGH

- As Found: Thalassemia

- ID: T5229

- Name: Sickle Cell Anemia

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000755

- Term: Anemia, Sickle Cell

- ID: D000013789

- Term: Thalassemia

### Misc Info Module

- Version Holder: 2024-05-31
