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

NCT01546051 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2012-03-07

No results posted yet for this study

Summary

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

  • Healthy

Interventions

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

DRUG

BCI-838

BCI-838 administered as a single 30 mg oral dose or matching placebo under fasted and fed conditions in a crossover design

DRUG

BCI-1038, BCI-1206 & BCI-1283

Three new pro-drugs administered as a 1 mg single oral doses under fasted conditions in a sequential design

DRUG

BCI-838

BCI-838 900 mg or matching placebo administered as a single oral dose under fasted conditions

Sponsors & Collaborators

  • BrainCells Inc.

    lead INDUSTRY

Principal Investigators

  • Principal Investigator · PRA Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-01-31
Completion
2012-02-29

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 NCT01546051 on ClinicalTrials.gov