## Protocol Section
### Identification Module
**NCT ID:** NCT04877379

**Brief Title:** VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers

**Official Title:** VNRX-7145-102: A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics (PK) of VNRX-7145 and VNRX-5024 (Ceftibuten) in Healthy Adult Volunteers

#### Organization Study ID Info
**ID:** VNRX-7145-102
#### Organization
**Class:** INDUSTRY
**Full Name:** Venatorx Pharmaceuticals, Inc.
#### Secondary ID Infos
**ID:** 272201600029C-P00007-9999-2
**Link:** https://reporter.nih.gov/quickSearch/272201600029C-P00007-9999-2
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2021-11-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-06-15

**Type:** ACTUAL

**Last Update Submit Date:** 2022-06-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-11-10

**Type:** ACTUAL

#### Start Date
**Date:** 2021-06-08

**Type:** ACTUAL

**Status Verified Date:** 2022-06

#### Study First Post Date
**Date:** 2021-05-07
**Type:** ACTUAL
**Study First Submit Date:** 2021-05-03
**Study First Submit QC Date:** 2021-05-03
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute of Allergy and Infectious Diseases (NIAID)

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Venatorx Pharmaceuticals, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This study will provide an initial assessment of the safety and PK of VNRX-7145 and VNRX-5024 (ceftibuten) when administered as single agents and with co-administration in a single dose cross-over design in Part 1. In Part 2, subjects will receive 500 mg of VNRX-7145 or matching placebo q8h for 10 days. VNRX-7145 and VNRX-5024 (ceftibuten) will be administered every 8 hours (q8h) for 10 days at 2 dose levels of VNRX-7145 in Part 3.

### Conditions Module

**Conditions:**

- Healthy Subjects

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SEQUENTIAL

**Intervention Model Description:** Part 1: Crossover Parts 2\&3: Parallel

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** Part 1: Unblinded Parts 2\&3: Blinded

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 53

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects will receive single doses of VNRX-7145 or VNRX-5024 alone and in combination. All subjects will receive study drug in the sequence specified by the randomization schedule.

**Intervention Names:**

- Drug: VNRX-7145

- Drug: VNRX-5024 (ceftibuten)

**Label:** Part 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Multiple dose administration of VNRX-7145 q8h for 10 days

**Intervention Names:**

- Drug: VNRX-7145

**Label:** Part 2A

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Multiple dose administration of placebo q8h for 10 days

**Intervention Names:**

- Drug: Placebo

**Label:** Part 2B

**Type:** PLACEBO_COMPARATOR

#### Arm Group 4

**Description:** Multiple dose administration of low dose VNRX-7145 + VNRX-5024

**Intervention Names:**

- Drug: VNRX-7145

- Drug: VNRX-5024 (ceftibuten)

**Label:** Part 3A

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** Multiple dose administration of high dose VNRX-7145 + VNRX-5024

**Intervention Names:**

- Drug: VNRX-7145

- Drug: VNRX-5024 (ceftibuten)

**Label:** Part 3B

**Type:** EXPERIMENTAL

#### Arm Group 6

**Description:** Multiple dose administration of Placebo (matching VNRX-7145 + VNRX-5024)

**Intervention Names:**

- Drug: Placebo

**Label:** Part 3C

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Part 1

- Part 2A

- Part 3A

- Part 3B

**Description:** β-lactamase inhibitor

**Name:** VNRX-7145

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Part 1

- Part 3A

- Part 3B

**Description:** β-lactam antibiotic

**Name:** VNRX-5024 (ceftibuten)

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Part 2B

- Part 3C

**Description:** Placebo

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** concentration time data

**Measure:** Part 1: Cmax

**Time Frame:** 0-48 hours

**Description:** Area under the concentration-time curve from time-zero extrapolated to infinity based on collected PK

**Measure:** Part 1: AUC0-inf

**Time Frame:** 0-48 hours

**Measure:** Parts 2&3: Number of subjects with adverse events

**Time Frame:** Day 15 (+2)

#### Secondary Outcomes

**Measure:** Part 1: Number of subjects with adverse events

**Time Frame:** Day 14 (+2)

**Measure:** Parts 2&3: AUC0-tau

**Time Frame:** Day 1

**Measure:** Parts 2&3: AUC0-tau

**Time Frame:** Day 10

**Measure:** Parts 2&3: Cmax

**Time Frame:** Day 1

**Measure:** Parts 2&3: Cmax

**Time Frame:** Day 10

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Healthy adults 18-55 years
2. Males or non-pregnant, non-lactating females
3. Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
4. Normal blood pressure
5. Normal lab tests

Exclusion Criteria:

1. History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders
2. History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
3. Use of antacid medications
4. Abnormal ECG or history of clinically significant abnormal rhythm disorder
5. Positive alcohol, drug, or tobacco use/test

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Groningen

**Country:** Netherlands

**Facility:** PRA Health Sciences - Early Development Services

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000900

- Term: Anti-Bacterial 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: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10789

- Name: Lactams

- Relevance: LOW

- As Found: Unknown

- ID: M25772

- Name: beta-Lactams

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M3444

- Name: Beta Lactam Antibiotics

- Relevance: LOW

- As Found: Unknown

- ID: M30450

- Name: beta-Lactamase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M1883

- Name: Ceftibuten

- Relevance: HIGH

- As Found: Follitropin Delta

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077722

- Term: Ceftibuten

### Misc Info Module

- Version Holder: 2024-05-24
