Serious infections
Conditions
Interventions
Part 1
Treatment name | Treatment | How often
Treatment 1A | VNRX-7145 500 mg | once
Treatment 1B | Ceftibuten 400 mg | once
Treatment 1C | VNRX-7145 500 mg and Ceftibuten 400 mg | once
Part 2 and 3
Sponsors
Venatorx Pharmaceuticals, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion 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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 To evaluate the PK of VNRX 7145, its active metabolite VNRX5236 and ceftibuten when a single dose of VNRX 7145 is co-administered with ceftibuten compared to single doses of VNRX-7145 or ceftibuten administered alone. Part 2 To evaluate the safety of repeated doses of 500 mg VNRX-7145 administered q8h for 10 days in healthy adult volunteers. Part 3 To evaluate the safety of multiple doses (10 days) of orally administered VNRX 7145 at 2 dose levels when co-administered with ceftibuten. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 To evaluate the safety of a single dose of VNRX-7145 co-administered with ceftibuten compared to VNRX 7145 or ceftibuten administered alone. Part 2 To evaluate the PK of VNRX-7145 and its active metabolite VNRX-5236 with repeated doses (q8h for 10 days) of 500 mg VNRX-7145 in healthy adult volunteers. Part 3 To evaluate the PK of VNRX-7145, its active metabolite VNRX-5236, and ceftibuten following multiple doses (10 days) of orally administered VNRX-7145 at 2 dose levels when co-administered with ceftibuten. | — |
Countries
Netherlands
Outcome results
None listed