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

NCT ID: NCT01546051

Last Updated: 2012-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-02-29

Brief 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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BCI-838 Food Effect Dosing Arm 1

Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.

Group Type: EXPERIMENTAL

BCI-838

Intervention Type: DRUG

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

BCI-838 Fasted Dosing (100 & 300 mg)

Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.

Group Type: EXPERIMENTAL

BCI-838

Intervention Type: DRUG

BCI-838 100 mg and 300 mg or matching placebo administered as single oral doses under fasted conditions in a sequential design

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.

Group Type: EXPERIMENTAL

BCI-1038, BCI-1206 & BCI-1283

Intervention Type: DRUG

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

BCI-838 Fasted Dosing (900 mg)

Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.

Group Type: EXPERIMENTAL

BCI-838

Intervention Type: DRUG

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

Interventions

BCI-838

BCI-838 100 mg and 300 mg or matching placebo administered as single oral doses under fasted conditions in a sequential design

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

BCI-838

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

BrainCells Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Principal Investigator

Role: PRINCIPAL_INVESTIGATOR

PRA Health Sciences

Locations

PRA International

Zuidlaren, , Netherlands

Countries

Netherlands

Other Identifiers

BCI-632-CL-002

Identifier Type: -

Identifier Source: org_study_id