VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 55
Updated:10/20/2018
Start Date:October 24, 2017
End Date:December 20, 2017

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VNRX-5133-103: A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics of VNRX-5133 in Healthy Adult Volunteers

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.


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
We found this trial at
1
site
9755 Ridge Drive
Lenexa, Kansas 66219
Phone: 913-210-5588
?
mi
from
Lenexa, KS
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