depression mood disorders
Conditions
Interventions
The study will consist of 3 groups, each group will will stay in the clinical
research centre for 11 days (10 nights).
During the study subjects will receive BCI-838 or inactive formulation
(placeb
we call
this *the study is blinded*. However, information on the administration of
study medication and placebo will be present in the clinical research facility,
in sealed envelopes, which can be
Sponsors
BrainCells Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy male and female subjects Age: 18 * 55 years, inclusive BMI: 18 * 30 kg/m2, inclusive Non smoker or moderate smoker (*5 cigarettes per day)
Exclusion criteria
Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerabilty of BCI-838 | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic of BCI-838 by analysis of plasma concentrations of BCI-838 and metabolite BCI-632 and Pharmacodynamic of BCI-838 by analysis/registration of brain activity (EEG) | — |
Countries
Netherlands
Outcome results
None listed