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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01546051
• Other study ID #: BCI-632-CL-002
• Status: Completed
• Phase: Phase 1
• First received: February 24, 2012
• Last updated: March 6, 2012
• Start date: October 2011
• Est. completion date: February 2012

Study information

• Verified date: March 2012
• Source: BrainCells Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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
• BCI-838
BCI-838 administered as a single 30 mg oral dose or matching placebo under fasted and fed conditions in a crossover design
• 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
• BCI-838
BCI-838 900 mg or matching placebo administered as a single oral dose under fasted conditions

Locations

Country	Name	City	State
Netherlands	PRA International	Zuidlaren

Sponsors (1)

Lead Sponsor	Collaborator
BrainCells Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Safety will be evaluated by adverse events, vital signs, ECG, clinical labs, and physical exam.	7 days	No
Secondary	Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel of BCI-838 and BCI-632	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	No