VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers

• Status: Completed
• Trial end date: 2017-12-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Venatorx Pharmaceuticals, Inc.
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Metronidazole

Criteria

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