VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers

Venatorx Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Bacterial Infections

Treatments: Drug: Placebo; Drug: Metronidazole; Drug: VNRX-5022; Drug: VNRX-5133

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT03332732

VNRX-5133-103

272201300019C-3-0-1 (U.S. NIH Grant/Contract)

17-0068 (Other Identifier)

Details and patient eligibility

About

This is a 2-part, drug-drug interaction study to evaluate potential PK interactions after single doses in Part 1 and multiple doses in Part 2. In Part 1, subjects will receive single dose of 5 treatments in a cross-over design; in Part 2 subjects will receive treatment for 10 days.

Enrollment: 42 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults
• Males or non-pregnant, non-lactating females
• Body Mass Index (BMI) between 18.5 - 32.0, inclusive
• Weight greater than or equal to 50 kg
• Suitable veins for cannulation

Exclusion criteria

• Employee of site or the sponsor
• Any disease that poses an unacceptable risk to participants
• Abnormal ECG
• Abnormal labs
• Abnormal vital signs
• Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
• Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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42 participants in 5 patient groups, including a placebo group

Part 1A

Experimental group

Description:

In Part 1A, subjects will receive single doses of VNRX-5133 and VNRX-5022 alone and in combination. All subjects will receive all treatments in the sequence specified by the randomization schedule..

Treatment:

Drug: VNRX-5133

Drug: VNRX-5022

Part 1B

Experimental group

Description:

In part 1B, subjects from Part 1A will receive metronidazole with or without VNRX-5133 + VNRX-5022. All subjects will receive all treatments in the sequence specified by the randomization schedule.

Treatment:

Drug: VNRX-5133

Drug: VNRX-5022

Drug: Metronidazole

Part 2 - 2A

Experimental group

Description:

Multiple dose administration of Low Dose VNRX-5133 + VNRX-5022

Treatment:

Drug: VNRX-5133

Drug: VNRX-5022

Part 2 - 2B

Experimental group

Description:

Multiple dose administration of High Dose VNRX-5133 + VNRX-5022

Treatment:

Drug: VNRX-5133

Drug: VNRX-5022

Part 2 - 2C

Placebo Comparator group

Description:

Multiple dose administration of Placebo (matching VNRX-5133 + VNRX-5022)

Treatment:

Drug: Placebo