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Clinical Trials/NL-OMON51149
NL-OMON51149
Completed
N/A

A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics of VNRX­7145 and Ceftibuten (VNRX­5024) in Healthy Adult Volunteers - DDI on safety of PK of VNRX-7145 and Ceftibuten (VNRX-5024)

Venatorx Pharmaceuticals, Inc.0 sites54 target enrollmentTBD
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ConditionsSerious infections10004018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Serious infections
Sponsor
Venatorx Pharmaceuticals, Inc.
Enrollment
54
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Willing to participate in the study, give written informed consent, and
  • •comply with the study restrictions including lifestyle restriction outlined in
  • •Section 6\.4 of the protocol.
  • •2\. Healthy male and female .subjects between 18 and 55 years of age (inclusive).
  • •3\. Body mass index (BMI): \>\=18\.5 kg/m2 and \<\=32\.0 kg/m2, at Screening.
  • •4\. Normal blood pressure at Screening and Day \-1, defined as a systolic value
  • •greater than or equal to 90 mm Hg and less than or equal to 140 mm Hg and a
  • •diastolic value less than 90 mm Hg. Values outside the range for inclusion may
  • •be retested once if there is a clinical rationale for the out\-of\-range value.
  • •5\. Urine dipstick results for protein are negative or trace at Screening and

Exclusion Criteria

  • •1\. Employee or family members of the clinical research organization (CRO), CRC,
  • •or the Sponsor.
  • •2\. Female who is pregnant, lactating, or planning to attempt to become pregnant
  • •during this study or within 90 days after dosing of study drug.
  • •3\. Male with a female partner who is pregnant or lactating or planning to
  • •become pregnant within 90 days after the last dose of study drug administration.
  • •4\. Subject is participating in any other clinical study that involves the
  • •administration of an investigational product at the time of screening or during
  • •the course of the study or has received treatment with an investigational
  • •product in the 30 days before Screening (90 days for an injectable biological

Outcomes

Primary Outcomes

Not specified

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