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A Multiple Ascending Dose Study of BCI-838 in Healthy Volunteers

NCT01548703 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-05-09

No results posted yet for this study

Summary

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BCI-838 and its metabolite BCI-632 in healthy male and female subjects.

Conditions

  • Healthy

Interventions

DRUG

BCI-838

BCI-838 100 mg or matching placebo administered once daily for 7 days

DRUG

BCI-838

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.

DRUG

BCI-838

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.

Sponsors & Collaborators

  • BrainCells Inc.

    lead INDUSTRY

Principal Investigators

  • Salah Hadi, MD · PRA Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01548703 on ClinicalTrials.gov