Healthy VolunteersPhase 1NCT04965402
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986166 in Healthy Japanese Participants
A Phase 1 study testing BMS-986166 in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986166 in healthy Japanese male and female participants of non-childbearing potential. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BMS-986166
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2021to 7 Feb 2022
- 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
- Japanese (both biological parents are ethnically Japanese)
- Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiograms (ECGs), and clinical laboratory evaluations
- Body Mass Index (BMI) of 18.0 to 32.0 kg/m^2, inclusive. BMI = weight (kg)/(height [m])^2
Who cannot join
- Significant acute or chronic medical illness judged to be clinically significant by the investigator and/or Sponsor's medical monitor
- History of heart disease, retinopathy, uveitis, other clinically significant ocular disease, gastrointestinal disease, stroke or transient ischemic attacks (TIA)
- Inability to tolerate oral medication
- Women who are of childbearing potential, breastfeeding, or lactating
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
United States1 site
West Coast Clinical Trials Global
Cypress, California, 90630
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Japanese Participants
The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986166 in healthy Japanese male and female participants of non-childbearing potential.
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986166, Placebo
- Keywords
- BMS-986166, Japan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986166Drug
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Panel 1: Dose 1 | Experimental | Not described Receives: Drug: BMS-986166 |
| Panel 2: Dose 2 | Experimental | Not described Receives: Drug: BMS-986166 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) parameters of BMS-986166: Maximum observed blood concentration (Cmax)
Measured: Day 1, Day 28
PK parameters of BMS-986166: Time of maximum observed blood concentration (Tmax)
Measured: Day 1, Day 28
PK parameters of BMS-986166: Area under the concentration-time curve within a dosing interval (AUC(TAU))
Measured: Day 1, Day 28
PK parameters of BMT-121795: Cmax
Measured: Day 1, Day 28
PK parameters of BMT-121795: Tmax
Measured: Day 1, Day 28
PK parameters of BMT-121795: AUC(TAU)
Measured: Day 1, Day 28
Secondary outcomes (34)
Incidence of all adverse events (AEs)
Measured: Up to 77 days
Severity of all AEs
Measured: Up to 77 days
Outcome of all AEs
Measured: Up to 77 days
Incidence of all serious adverse events (SAEs)
Measured: Up to 77 days
Severity of all SAEs
Measured: Up to 77 days
Outcome of all SAEs
Measured: Up to 77 days
Severity of all AEs regardless of seriousness criteria
Measured: Up to 77 days
Investigator causality assessment of all AEs regardless of seriousness criteria
Measured: Up to 77 days
Outcomes of all AEs regardless of seriousness criteria
Measured: Up to 77 days
Incidence of clinically significant changes in physical examination findings
Measured: Up to 77 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
PR interval: The time from the onset of the P wave to the start of the QRS complex
Measured: Up to 77 days
Incidence of clinically significant changes in ECG parameters: QRS interval
QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Measured: Up to 77 days
Incidence of clinically significant changes in ECG parameters: QT interval
QT interval: Measured from the beginning of the QRS complex to the end of the T wave
Measured: Up to 77 days
Incidence of clinically significant changes in ECG parameters: QTcF interval
QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Measured: Up to 77 days
Incidence of clinically significant changes in continuous cardiac monitoring data
Measured: Up to 77 days
Incidence of clinically significant changes in vital signs: Body temperature
Measured: Up to 77 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Measured: Up to 77 days
Incidence of clinically significant changes in vital signs: Blood pressure
Measured: Up to 77 days
Incidence of clinically significant changes in vital signs: Heart rate
Measured: Up to 77 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Measured: Up to 77 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Measured: Up to 77 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Measured: Up to 77 days
Incidence of clinically significant changes from baseline values in electrocardiogram (ECG) parameters: PR interval
Measured: Up to 77 days
Incidence of clinically significant changes from baseline values in ECG parameters: QRS interval
Measured: Up to 77 days
Incidence of clinically significant changes from baseline values in ECG parameters: QT interval
Measured: Up to 77 days
Incidence of clinically significant changes from baseline values in ECG parameters: QTcF interval
Measured: Up to 77 days
Incidence of clinically significant changes from baseline values in continuous cardiac monitoring data
Measured: Up to 77 days
Incidence of clinically significant changes from baseline values in vital signs: Body temperature
Measured: Up to 77 days
Incidence of clinically significant changes from baseline values in vital signs: Respiratory rate
Measured: Up to 77 days
Incidence of clinically significant changes from baseline values in vital signs: Blood pressure
Measured: Up to 77 days
Incidence of clinically significant changes from baseline values in vital signs: Heart rate
Measured: Up to 77 days
Incidence of clinically significant changes from baseline values in clinical laboratory results: Hematology tests
Measured: Up to 77 days
Incidence of clinically significant changes from baseline values in clinical laboratory results: Clinical Chemistry tests
Measured: Up to 77 days
Incidence of clinically significant changes from baseline values in clinical laboratory results: Urinalysis tests
Measured: Up to 77 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start15 Jul 2021
- Primary completion7 Feb 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965402
- Sponsor's protocol ID
- IM018-007
- Status last verified
- Feb 2022
- First submitted
- 7 Jul 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Japanese Participants
- ClinicalTrials.gov ID
- NCT04965402
- Acronym / sponsor ID
- IM018-007
- Conditions
- Healthy Volunteers
- Keywords
- BMS-986166, Japan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 16 Jul 2021 (actual)
- 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.
The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986166 in healthy Japanese male and female participants of non-childbearing potential.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Panel 1: Dose 1 | Experimental | Drug: BMS-986166 |
| Panel 2: Dose 2 | Experimental | Drug: BMS-986166 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Japanese (both biological parents are ethnically Japanese)
- Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiograms (ECGs), and clinical laboratory evaluations
- Body Mass Index (BMI) of 18.0 to 32.0 kg/m^2, inclusive. BMI = weight (kg)/(height [m])^2
Key exclusion criteria (5 listed)
- Significant acute or chronic medical illness judged to be clinically significant by the investigator and/or Sponsor's medical monitor
- History of heart disease, retinopathy, uveitis, other clinically significant ocular disease, gastrointestinal disease, stroke or transient ischemic attacks (TIA)
- Inability to tolerate oral medication
- Women who are of childbearing potential, breastfeeding, or lactating
- Other protocol-defined inclusion/exclusion criteria apply
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 |
|---|---|---|
| BMS-986166Specified dose on specified days | Drug | Panel 1: Dose 1, Panel 2: Dose 2 |
| PlaceboSpecified dose on specified days | Other | Placebo |
Primary outcome
Pharmacokinetic (PK) parameters of BMS-986166: Maximum observed blood concentration (Cmax)
Time frame: Day 1, Day 28
PK parameters of BMS-986166: Time of maximum observed blood concentration (Tmax)
Time frame: Day 1, Day 28
PK parameters of BMS-986166: Area under the concentration-time curve within a dosing interval (AUC(TAU))
Time frame: Day 1, Day 28
PK parameters of BMT-121795: Cmax
Time frame: Day 1, Day 28
PK parameters of BMT-121795: Tmax
Time frame: Day 1, Day 28
PK parameters of BMT-121795: AUC(TAU)
Time frame: Day 1, Day 28
34 secondary outcomes
Incidence of all adverse events (AEs)
Time frame: Up to 77 days
Severity of all AEs
Time frame: Up to 77 days
Outcome of all AEs
Time frame: Up to 77 days
Incidence of all serious adverse events (SAEs)
Time frame: Up to 77 days
Severity of all SAEs
Time frame: Up to 77 days
Outcome of all SAEs
Time frame: Up to 77 days
Severity of all AEs regardless of seriousness criteria
Time frame: Up to 77 days
Investigator causality assessment of all AEs regardless of seriousness criteria
Time frame: Up to 77 days
Outcomes of all AEs regardless of seriousness criteria
Time frame: Up to 77 days
Incidence of clinically significant changes in physical examination findings
Time frame: Up to 77 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Time frame: Up to 77 days
Incidence of clinically significant changes in ECG parameters: QRS interval
Time frame: Up to 77 days
Incidence of clinically significant changes in ECG parameters: QT interval
Time frame: Up to 77 days
Incidence of clinically significant changes in ECG parameters: QTcF interval
Time frame: Up to 77 days
Incidence of clinically significant changes in continuous cardiac monitoring data
Time frame: Up to 77 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 77 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 77 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 77 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 77 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 77 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to 77 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in electrocardiogram (ECG) parameters: PR interval
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in ECG parameters: QRS interval
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in ECG parameters: QT interval
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in ECG parameters: QTcF interval
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in continuous cardiac monitoring data
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in vital signs: Body temperature
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in vital signs: Respiratory rate
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in vital signs: Blood pressure
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in vital signs: Heart rate
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in clinical laboratory results: Hematology tests
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in clinical laboratory results: Urinalysis tests
Time frame: Up to 77 days
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 Mar 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 BMS-986166 in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
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 3 inclusion and 5 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 Mar 2022. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Pharmacokinetic (PK) parameters of BMS-986166: Maximum observed blood concentration (Cmax) (time frame: Day 1, Day 28). The study lists 6 primary outcomes in all. 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 Mar 2022.