## Protocol Section
### Identification Module
**NCT ID:** NCT06204679

**Brief Title:** Pharmacokinetics of Fixed-Dose Combination Tablet of Bemnifosbuvir and Ruzasvir

**Official Title:** A Phase 1, Open-Label Study to Assess Comparative Bioavailability and Effect of Food on a Prototype Fixed-Dose Combination of Bemnifosbuvir and Ruzasvir Versus Individual Dosage Forms Taken Concomitantly in Healthy Adult Subjects

#### Organization Study ID Info
**ID:** AT-01B-005
#### Organization
**Class:** INDUSTRY
**Full Name:** Atea Pharmaceuticals, Inc.
### Status Module
#### Completion Date
**Date:** 2024-02-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-12

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-11

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-02-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-14

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2024-01-12
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-02
**Study First Submit QC Date:** 2024-01-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Atea Pharmaceuticals, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study will assess comparative bioavailability and effect of food on a prototype fixed-dose combination (FDC) of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in healthy subjects

### Conditions Module

**Conditions:**

- Healthy Volunteer Study

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Day 1, Day 7, Day 13

**Intervention Names:**

- Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditions

**Label:** FDC Fasting

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Day 1, Day 7, Day 13

**Intervention Names:**

- Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditions

**Label:** FDC Fed

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Day 1, Day 7, Day 13

**Intervention Names:**

- Drug: Bemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditions

**Label:** Reference Fasting

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- FDC Fasting

**Description:** A Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR)

**Name:** Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditions

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- FDC Fed

**Description:** A Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR)

**Name:** Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditions

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Reference Fasting

**Description:** Bemnifosbuvir (BEM) and Ruzasvir (RZR) as separate formulations

**Name:** Bemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditions

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Maximum plasma concentration (Cmax)

**Measure:** Pharmacokinetics (PK) of FDC compared to reference:(Cmax)

**Time Frame:** Day 1, Day 7, Day 13

**Description:** Area under the plasma concentration-time curve (AUC)

**Measure:** Pharmacokinetics (PK) of FDC compared to reference:(AUC)

**Time Frame:** Day 1, Day 7, Day 13

**Description:** Maximum plasma concentration (Cmax)

**Measure:** Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(Cmax)

**Time Frame:** Day 1, Day 7, Day 13

**Description:** Area under the plasma concentration-time curve (AUC)

**Measure:** Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(AUC)

**Time Frame:** Day 1, Day 7, Day 13

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug.
* Minimum body weight of 50 kg and body mass index (BMI) of 18-30 kg/m2.
* Willing to comply with the study requirements and to provide written informed consent.

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2.
* Abuse of alcohol or drugs.
* Use of other investigational drugs within 28 days of dosing.
* Concomitant use of prescription medications, or systemic over-the-counter medications.
* Other clinically significant medical conditions or laboratory abnormalities.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ateaclinicaltrials@ateapharma.com

**Name:** Atea Study Clinical Trials Administrator

**Phone:** 888-481-1607

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Cypress

**Country:** United States

**Facility:** Atea Study Site

**State:** California

**Status:** RECRUITING

**Zip:** 90630

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M263854

- Name: Ruzasvir

- Relevance: HIGH

- As Found: Mood stabilizer

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000621654

- Term: Ruzasvir

### Misc Info Module

- Version Holder: 2024-05-24
