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

BrainCells Inc.

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BCI-1038, BCI-1206 & BCI-1283; Drug: BCI-838

Study type: Interventional

Funder types: Industry

Identifiers

NCT01546051

BCI-632-CL-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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31 participants in 4 patient groups

BCI-838 Food Effect Dosing Arm 1

Experimental group

Description:

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

Treatment:

Drug: BCI-838

Drug: BCI-838

Drug: BCI-838

BCI-838 Fasted Dosing (100 & 300 mg)

Experimental group

Description:

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

Treatment:

Drug: BCI-838

Drug: BCI-838

Drug: BCI-838

BCI-1038, BCI-1206 & BCI-1283

Experimental group

Description:

Six subjects will be enrolled, all 6 will receive single doses of BCI-1038, BCI-1206 and BCI-1283.

Treatment:

Drug: BCI-1038, BCI-1206 & BCI-1283

BCI-838 Fasted Dosing (900 mg)

Experimental group

Description:

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

Treatment:

Drug: BCI-838

Drug: BCI-838

Drug: BCI-838