VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers

Basilea Pharmaceutica

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Placebo; Drug: VNRX-5024 (ceftibuten); Drug: VNRX-7145

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT04877379

VNRX-7145-102

272201600029C-P00007-9999-2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will provide an initial assessment of the safety and PK of VNRX-7145 and VNRX-5024 (ceftibuten) when administered as single agents and with co-administration in a single dose cross-over design in Part 1. In Part 2, subjects will receive 500 mg of VNRX-7145 or matching placebo q8h for 10 days. VNRX-7145 and VNRX-5024 (ceftibuten) will be administered every 8 hours (q8h) for 10 days at 2 dose levels of VNRX-7145 in Part 3.

Enrollment: 53 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adults 18-55 years
2. Males or non-pregnant, non-lactating females
3. Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
4. Normal blood pressure
5. Normal lab tests

Exclusion criteria

1. History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders
2. History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
3. Use of antacid medications
4. Abnormal ECG or history of clinically significant abnormal rhythm disorder
5. Positive alcohol, drug, or tobacco use/test

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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53 participants in 6 patient groups, including a placebo group

Part 1

Experimental group

Description:

Subjects will receive single doses of VNRX-7145 or VNRX-5024 alone and in combination. All subjects will receive study drug in the sequence specified by the randomization schedule.

Treatment:

Drug: VNRX-7145

Drug: VNRX-5024 (ceftibuten)

Part 2A

Experimental group

Description:

Multiple dose administration of VNRX-7145 q8h for 10 days

Treatment:

Drug: VNRX-7145

Part 2B

Placebo Comparator group

Description:

Multiple dose administration of placebo q8h for 10 days

Treatment:

Drug: Placebo

Part 3A

Experimental group

Description:

Multiple dose administration of low dose VNRX-7145 + VNRX-5024

Treatment:

Drug: VNRX-7145

Drug: VNRX-5024 (ceftibuten)

Part 3B

Experimental group

Description:

Multiple dose administration of high dose VNRX-7145 + VNRX-5024

Treatment:

Drug: VNRX-7145

Drug: VNRX-5024 (ceftibuten)

Part 3C

Placebo Comparator group

Description:

Multiple dose administration of Placebo (matching VNRX-7145 + VNRX-5024)

Treatment:

Drug: Placebo