CompletedPhase 1ketamine

A Study of BCI-838 and Several BCI-632 Prodrugs in Healthy Volunteers

Sponsored by BrainCells Inc.

NCT ID
NCT01546051
Target Enrollment
31 participants
Start Date
2011-10
Est. Completion
2012-02

About This Study

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.

Conditions Studied

Healthy

Interventions

  • BCI-838
  • BCI-838
  • BCI-1038, BCI-1206 & BCI-1283
  • BCI-838

Eligibility

Sex:MALE
Age:18 Years - 55 Years
Healthy Volunteers:Yes
View full eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Study Locations (1)

PRA International
Zuidlaren, Netherlands

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source