VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers

V

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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