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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- BrainCells Inc.
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Safety
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
BCI-838 Food Effect Dosing Arm 1
Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.
Intervention: BCI-838 (Drug)
BCI-838 Fasted Dosing (100 & 300 mg)
Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.
Intervention: BCI-838 (Drug)
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.
Intervention: BCI-1038, BCI-1206 & BCI-1283 (Drug)
BCI-838 Fasted Dosing (900 mg)
Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.
Intervention: BCI-838 (Drug)
Outcomes
Primary Outcomes
Safety
Time Frame: 7 days
Safety will be evaluated by adverse events, vital signs, ECG, clinical labs, and physical exam.
Secondary Outcomes
- Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel of BCI-838 and BCI-632(predose and at specified intervals up to 72 hours post-dose)