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Keep this study
Lead
BrainCells Inc.
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.
Age
18–55
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
Adult male healthy volunteer, 18-55 years of age
Body Mass Index (BMI) between 18.0 to 30.0 kg/m2 inclusive
Good general health as determined by medical history and physical examination with no clinically significant medical findings and no clinically relevant medical or surgical history and no acute or ongoing conditions within the past 30 days
Able to participate and willing to give written informed consent and to comply with the study restrictions
You may not be if
Clinically significant medical abnormality, chronic disease or history or presence of significant pulmonary, gastrointestinal, metabolic, cardiac, hepatic, renal or neurological disorder
History or current use of alcohol abuse or drug addiction
Participation in a drug study within 60 days prior to drug administration.
Participation in more than 3 other drug studies in the 10 months preceding the start of this study
Donation or blood loss of more than 50 mL of blood within 60 days prior to the first drug administration. Donation of more than 1.5 liters of blood in the 10 months preceding the start of this study
Illness within 5 days prior to drug administration
