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

March 6, 2012 updated by: BrainCells Inc.

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetic and Food Effect of BCI-838; and, An Open-Label Minidose Bioavailability Study to Compare Several BCI-632 Pro-drug Candidates in Healthy Male Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Zuidlaren, Netherlands, 9471 GP
        • PRA International

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BCI-838 Food Effect Dosing Arm 1
Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.
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-838
BCI-838 900 mg or matching placebo administered as a single oral dose under fasted conditions
Experimental: BCI-838 Fasted Dosing (100 & 300 mg)
Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.
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-838
BCI-838 900 mg or matching placebo administered as a single oral dose under fasted conditions
Experimental: BCI-1038, BCI-1206 & BCI-1283
Six subjects will be enrolled, all 6 will receive single doses of BCI-1038, BCI-1206 and BCI-1283.
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
Experimental: BCI-838 Fasted Dosing (900 mg)
Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.
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-838
BCI-838 900 mg or matching placebo administered as a single oral dose under fasted conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 7 days
Safety will be evaluated by adverse events, vital signs, ECG, clinical labs, and physical exam.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel of BCI-838 and BCI-632
Time Frame: predose and at specified intervals up to 72 hours post-dose
The pharmacokinetics of BCI-838 and its metabolite BCI-632, an assessment of the dose proportionality of the pharmacokinetics following single ascending doses of BCI-838, and an evaluation of the relative bioavailability and pharmacokinetics of the metabolite BCI-632 following oral administration of several new pro-drug candidates will be completed by assessment of Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel.
predose and at specified intervals up to 72 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BrainCells Inc.

Investigators

  • Principal Investigator: Principal Investigator, PRA Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

February 24, 2012

First Submitted That Met QC Criteria

March 6, 2012

First Posted (Estimate)

March 7, 2012

Study Record Updates

Last Update Posted (Estimate)

March 7, 2012

Last Update Submitted That Met QC Criteria

March 6, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCI-632-CL-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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