Pharmacokinetics
Conditions
Brief summary
This is an open label, two period (fasted and fed), crossover study in up to 3 cohorts of 12 healthy adult participants per cohort (up to 36 participants in total). The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.
Interventions
DRUGVNRX-7145
Single oral dose
DRUGCeftibuten
Single oral dose
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Basilea Pharmaceutica
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults 18-65 years * Males or non-pregnant, non-lactating females * Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2 * Laboratory values meeting defined entry criteria
Exclusion criteria
* History of drug allergy or hypersensitivity to penicillin, cephalosporin, or β-lactam antibacterial drug * Conditions that potentially alter absorption and/or excretion of orally administered drugs * Congenital or acquired immunodeficiency syndrome * Positive alcohol, drug, or tobacco use/test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects | Maximum observed plasma concentration (Cmax) |
| AUC0-t | 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects | Area under the plasma concentration-time curve (AUC) from time 0 up to the last quantifiable concentration at time t (AUC0-t) |
| AUC0-inf | 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects | AUC from time 0 extrapolated to infinity (AUC0-inf) |
Countries
United States
Outcome results
None listed