A Phase 1 interventional study of BCI-838 and BCI-838 in Healthy, sponsored by BrainCells Inc.. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-07.
Sponsored by BrainCells Inc. · Phase 1, Interventional, and Treatment
This study will evaluate the safety, tolerability and pharmacokinetics of BCI-838, its metabolite BCI-632 and several new pro-drugs in healthy male subjects.
The first phase of this study will evaluate the safety and tolerability of BCI-838 following oral administration of single doses of BCI-838 in healthy male subjects. The pharmacokinetics of BCI-838 and its metabolite BCI-632 following single ascending doses of BCI-838 will be evaluated, as will the effect of food on the pharmacokinetics of BCI-838 and its metabolite following single oral doses of BCI-838 in healthy male subjects.
The second phase of this study will evaluate and compare the relative bioavailability and PK of the metabolite BCI-632 following single oral administration of several new pro-drug candidates in healthy male subjects.
8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 31 is below the median of 84 across 6,869 interventional studies indexed under Depression.
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Exclusion Criteria:
Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.
Drug: BCI-838
Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.
Drug: BCI-838
Six subjects will be enrolled, all 6 will receive single doses of BCI-1038, BCI-1206 and BCI-1283.
Drug: BCI-1038, BCI-1206 & BCI-1283
Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.
Drug: BCI-838
BCI-838 100 mg and 300 mg or matching placebo administered as single oral doses under fasted conditions in a sequential design
BCI-838 administered as a single 30 mg oral dose or matching placebo under fasted and fed conditions in a crossover design
Three new pro-drugs administered as a 1 mg single oral doses under fasted conditions in a sequential design
BCI-838 900 mg or matching placebo administered as a single oral dose under fasted conditions
Safety
Safety will be evaluated by adverse events, vital signs, ECG, clinical labs, and physical exam.
Time frame: 7 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, an assessment of the dose proportionality of the pharmacokinetics following single ascending doses of BCI-838, and an evaluation of the relative bioavailability and pharmacokinetics of the metabolite BCI-632 following oral administration of several new pro-drug candidates will be completed by assessment of Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel.
Time frame: predose and at specified intervals up to 72 hours post-dose
The record gives a start of Oct 2011, a primary completion of Jan 2012 and a completion of Feb 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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