This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BCI-838 and its metabolite BCI-632 in healthy male and female subjects.
This study will evaluate the safety and tolerability following oral administration of multiple doses of BCI-838 in healthy male and female subjects. The pharmacokinetic profile of multiple oral doses of BCI-838 in healthy male and female subjects will also be assessed. In addition, the pharmacodynamic effects of BCI-838 on the central nervous system using quantitative electroencephalogram analysis will be studied.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
BCI-838 100 mg or matching placebo administered once daily for 7 days
BCI-838 or matching placebo administered once daily for 7 days; the dose of BCI-838 will be determined based on the safety and PK data from the preceding dosing arm.
BCI-838 or matching placebo administered once daily for 7 days; the dose of BCI-838 will be determined based on the safety and PK data from the preceding dosing arm.
PRA International
Zuidlaren, Netherlands
Safety
Safety will be evaluated by adverse events, vital signs, ECG, clinical labs, and physical exam.
Time frame: 14 days
Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel of BCI-838 and BCI-632
The pharmacokinetics of BCI-838 and its metabolite BCI-632 will be completed by assessment of Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel.
Time frame: predose, at specified timepoints during the 7-day dosing period, and at Day 10 (72 hours post-dose)
Quantitative EEG (qEEG) assessments
The pharmacodynamic effects of BCI-838 on the central nervous system will be evaluated using quantitative electroencephalogram analysis.
Time frame: predose, and at specified timepoints during the 7-day dosing period
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