HealthyPhase 1NCT01548703
A Multiple Ascending Dose Study of BCI-838 in Healthy Volunteers
A Phase 1 study testing BCI-838 in people with Healthy, run by BrainCells Inc. at 1 site in Netherlands.
Trial summary
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BCI-838 and its metabolite BCI-632 in healthy male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BCI-838
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2012to Apr 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult male and female healthy volunteers, 18-55 years of age
- Body Mass Index (BMI) between 18.0 to 30.0 kg/m2 inclusive
- Female subjects must have a negative pregnancy test at screening and admission. Females of childbearing potential (not at least 2 years postmenopausal or surgically sterile) must be using a reliable, medically acceptable form of contraception for at least 30 days prior to the screening visit and must agree to continue such use throughout the duration of the study and for 3 months after the final dose of study drug.
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of BCI 838 in Healthy Adult Subjects
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BCI-838 and its metabolite BCI-632 in healthy male and female subjects.
Read the detailed description
This study will evaluate the safety and tolerability following oral administration of multiple doses of BCI-838 in healthy male and female subjects. The pharmacokinetic profile of multiple oral doses of BCI-838 in healthy male and female subjects will also be assessed. In addition, the pharmacodynamic effects of BCI-838 on the central nervous system using quantitative electroencephalogram analysis will be studied.
- Conditions
- Healthy
- Being tested
- BCI-838
- Keywords
- metabotropic glutamate receptors 2 and 3, antagonist, mGluR, ketamine, BDNF, Depression, Major Depressive Disorder, Treatment Resistant Depression, Mood Disorder, Phase 1 safety, tolerability and pharmacokinetics study
- Medical subject headings
- Depression, Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCI-838Drug
BCI-838 100 mg or matching placebo administered once daily for 7 days
BCI-838Drug
BCI-838 or matching placebo administered once daily for 7 days; the dose of BCI-838 will be determined based on the safety and PK data from the preceding dosing arm.
BCI-838Drug
BCI-838 or matching placebo administered once daily for 7 days; the dose of BCI-838 will be determined based on the safety and PK data from the preceding dosing arm.
| Study group | Role | What they receive |
|---|---|---|
| BCI-838 Dosing Arm 1 | Experimental | Ten subjects will be enrolled, 8 will receive BCI-838 and 2 will receive matching placebo. Receives: Drug: BCI-838 |
| BCI-838 Dosing Arm 2 | Experimental | Ten subjects will be enrolled, 8 will receive BCI-838 and 2 will receive matching placebo. Receives: Drug: BCI-838 |
| BCI-838 Dosing Arm 3 | Experimental | Ten subjects will be enrolled, 8 will receive BCI-838 and 2 will receive matching placebo. Receives: Drug: BCI-838 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety will be evaluated by adverse events, vital signs, ECG, clinical labs, and physical exam.
Measured: 14 days
Secondary outcomes (2)
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 will be completed by assessment of Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel.
Measured: predose, at specified timepoints during the 7-day dosing period, and at Day 10 (72 hours post-dose)
Quantitative EEG (qEEG) assessments
The pharmacodynamic effects of BCI-838 on the central nervous system will be evaluated using quantitative electroencephalogram analysis.
Measured: predose, and at specified timepoints during the 7-day dosing period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrainCells Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Salah Hadi, MD, Principal investigator, PRA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548703
- Sponsor's protocol ID
- BCI-632-CL-003
- Status last verified
- May 2012
- First submitted
- 27 Feb 2012
- Last updated
- 9 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of BCI 838 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01548703
- Acronym / sponsor ID
- BCI-632-CL-003
- Conditions
- Healthy
- Keywords
- metabotropic glutamate receptors 2 and 3, antagonist, mGluR, ketamine, BDNF, Depression, Major Depressive Disorder, Treatment Resistant Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BrainCells Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BCI-838 and its metabolite BCI-632 in healthy male and female subjects.
Detailed description
This study will evaluate the safety and tolerability following oral administration of multiple doses of BCI-838 in healthy male and female subjects. The pharmacokinetic profile of multiple oral doses of BCI-838 in healthy male and female subjects will also be assessed. In addition, the pharmacodynamic effects of BCI-838 on the central nervous system using quantitative electroencephalogram analysis will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BCI-838 Dosing Arm 1 | Experimental | Drug: BCI-838Ten subjects will be enrolled, 8 will receive BCI-838 and 2 will receive matching placebo. |
| BCI-838 Dosing Arm 2 | Experimental | Drug: BCI-838Ten subjects will be enrolled, 8 will receive BCI-838 and 2 will receive matching placebo. |
| BCI-838 Dosing Arm 3 | Experimental | Drug: BCI-838Ten subjects will be enrolled, 8 will receive BCI-838 and 2 will receive matching placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult male and female healthy volunteers, 18-55 years of age
- Body Mass Index (BMI) between 18.0 to 30.0 kg/m2 inclusive
- Female subjects must have a negative pregnancy test at screening and admission. Females of childbearing potential (not at least 2 years postmenopausal or surgically sterile) must be using a reliable, medically acceptable form of contraception for at least 30 days prior to the screening visit and must agree to continue such use throughout the duration of the study and for 3 months after the final dose of study drug.
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCI-838BCI-838 100 mg or matching placebo administered once daily for 7 days | Drug | BCI-838 Dosing Arm 1 |
| BCI-838BCI-838 or matching placebo administered once daily for 7 days; the dose of BCI-838 will be determined based on the safety and PK data from the preceding dosing arm. | Drug | BCI-838 Dosing Arm 2 |
| BCI-838BCI-838 or matching placebo administered once daily for 7 days; the dose of BCI-838 will be determined based on the safety and PK data from the preceding dosing arm. | Drug | BCI-838 Dosing Arm 3 |
Primary outcome
Safety
Time frame: 14 days
Safety will be evaluated by adverse events, vital signs, ECG, clinical labs, and physical exam.
2 secondary outcomes
Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel of BCI-838 and BCI-632
Time frame: predose, at specified timepoints during the 7-day dosing period, and at Day 10 (72 hours post-dose)
Quantitative EEG (qEEG) assessments
Time frame: predose, and at specified timepoints during the 7-day dosing period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salah Hadi, MD principal investigator
PRA Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BCI-838 in people with Healthy, run by BrainCells Inc. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2012.