A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics of VNRX­7145 and Ceftibuten (VNRX­5024) in Healthy Adult Volunteers

Completed

• Conditions: 10004018; Serious infections

• Registration Number: NL-OMON51149
• Lead Sponsor: Venatorx Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 54

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
Day -1.

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
agent). See Protocol Section 7.6 Concomitant Treatment for more details.
5. Subject has a congenital or acquired immunodeficiency syndrome.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part 1<br /><br><br /><br>To evaluate the PK of VNRX 7145, its active metabolite VNRX­5236 and ceftibuten<br /><br>when a single dose of VNRX 7145 is co-administered with ceftibuten compared to<br /><br>single doses of VNRX-7145 or ceftibuten administered alone.<br /><br><br /><br>Part 2<br /><br><br /><br>To evaluate the safety of repeated doses of 500 mg VNRX-7145 administered q8h<br /><br>for 10 days in healthy adult volunteers.<br /><br><br /><br><br /><br>Part 3<br /><br><br /><br>To evaluate the safety of multiple doses (10 days) of orally administered VNRX­<br /><br>7145 at 2 dose levels when co-administered with ceftibuten.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Part 1<br /><br><br /><br>To evaluate the safety of a single dose of VNRX-7145 co-administered with<br /><br>ceftibuten compared to VNRX 7145 or ceftibuten administered alone.<br /><br><br /><br>Part 2<br /><br><br /><br>To evaluate the PK of VNRX-7145 and its active metabolite VNRX-5236 with<br /><br>repeated doses (q8h for 10 days) of 500 mg VNRX-7145 in healthy adult<br /><br>volunteers.<br /><br><br /><br>Part 3<br /><br><br /><br>To evaluate the PK of VNRX-7145, its active metabolite VNRX-5236, and<br /><br>ceftibuten following multiple doses (10 days) of orally administered VNRX-7145<br /><br>at 2 dose levels when co-administered with ceftibuten.</p><br>