VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Bacterial Infections

In brief

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.

Key facts

Study ID

NCT03332732

Run by

Venatorx Pharmaceuticals, Inc.

People needed

42

Starts

2017-10-24

Expected to finish

2017-12-20

Last updated by the study team

2018-10-18

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• PRAHS — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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