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 |
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.
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
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