To assess the pharmacokinetics of 3 doses and the food effect of a single high dose of BBI-5000 capsules in healthy adult subjects.
This is an open-label, randomized, 4-period, 4-way crossover, 4-sequence study to evaluate the pharmacokinetics (PK) and food effect of BBI-5000 capsules in healthy adult subjects. Participating subjects will receive a single oral dose of BBI-5000 followed by a washout period of 7-14 days between doses. The treatment period will be followed by 5-10 day follow-up period. PK and PD will be assessed by blood sampling through 72 hours postdose. Safety will be assessed through collection of vital signs, adverse events, physical examination, ECGs and clinical laboratory tests.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
BBI-5000 low dose, middle dose, or high doses
Celerion Inc.
Lincoln, Nebraska, United States
Plasma concentrations after single dosing of BBI-5000 for BBI-5000 and 3 metabolites
Time frame: Week 4
Area Under Curve (AUC) for BBI-5000 and 3 metabolites
Time frame: Week 4
Maximum Plasma Concentration (Cmax) for BBI-5000 and 3 metabolites
Time frame: Week 4
Time of Occurrence of Cmax (Tmax)
Time frame: Week 4
Clearance (CL/F)
Time frame: Week 4
Terminal plasma elimination rate constant for BBI-5000 and the 3 metabolites
Time frame: Week 4
BBI-5000 concentrations in plasma after dosing in fed and fasted conditions
Time frame: Week 4
Half-life for BBI-5000 and the 3 metabolites
Time frame: Week 4
Safety and tolerability as measured by assessment of treatment-related adverse events, safety laboratory, vital signs, electrocardiogram and physical examination results
Time frame: Week 4
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