Status:
COMPLETED
VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers
Lead Sponsor:
Basilea Pharmaceutica
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 des...
Eligibility Criteria
Inclusion
- Healthy adults 18-55 years
- Males or non-pregnant, non-lactating females
- Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
- Normal blood pressure
- Normal lab tests
Exclusion
- History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders
- History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
- Use of antacid medications
- Abnormal ECG or history of clinically significant abnormal rhythm disorder
- Positive alcohol, drug, or tobacco use/test
Key Trial Info
Start Date :
June 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2021
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04877379
Start Date
June 8 2021
End Date
November 10 2021
Last Update
December 8 2025
Active Locations (1)
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1
PRA Health Sciences - Early Development Services
Groningen, Netherlands