HealthyPhase 1NCT02790125
A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects
A Phase 1 study testing BMS-986166 in people with Healthy, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The primary purpose of this study is to determine if single doses of BMS-986166 are safe and well tolerated in healthy male subjects and female subjects 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
- What is being tested?
- BMS-986166
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2016to 7 Nov 2017
- 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
- Healthy female subjects of non-childbearing potential or male subjects as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations
- Ages 18 to 55 years
- Female subjects must provide documentation of an acceptable method of surgical sterilization or meet the protocol criteria for menopause
Who cannot join
- Any acute or chronic medical illness judged to be clinically significant by the Investigator and/or Sponsor medical monitor
- Any acute or chronic bacterial, fungal or viral infection, including tuberculosis, HIV, hepatitis B or hepatitis C, as defined in the protocol
- History of heart disease, neurological disease, eye disorders or gastrointestinal disorders or surgery (including cholecystectomy)
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs or clinical laboratory tests
- Smoking or nicotine use, drug or alcohol abuse within 6 months of starting the study
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of this study is to determine if single doses of BMS-986166 are safe and well tolerated in healthy male subjects and female subjects of non-childbearing potential.
- Conditions
- Healthy
- Being tested
- BMS-986166, Placebo matching BMS-986166
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986166Drug
Placebo matching BMS-986166Drug
| Study group | Role | What they receive |
|---|---|---|
| Dose Panel 1 | Experimental | BMS-986166 or Placebo matching BMS-986166
Single oral dose of solution as specified Receives: Drug: BMS-986166; Drug: Placebo matching BMS-986166 |
| Dose Panel 2 | Experimental | BMS-986166 or Placebo matching BMS-986166
Single oral dose of solution as specified Receives: Drug: BMS-986166; Drug: Placebo matching BMS-986166 |
| Dose Panel 3 | Experimental | BMS-986166 or Placebo matching BMS-986166
Single oral dose of solution as specified Receives: Drug: BMS-986166; Drug: Placebo matching BMS-986166 |
| Dose Panel 4 | Experimental | BMS-986166 or Placebo matching BMS-986166
Multiple ascending solid dose formulation as specified Receives: Drug: BMS-986166; Drug: Placebo matching BMS-986166 |
| Dose Panel 5a/b/c | Experimental | BMS-986166
Single oral solid dose formulation under fasting/fed/fasting with famotidine conditions Receives: Drug: BMS-986166 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of All Adverse Events (AEs)
Measured: Baseline Day -1 to Day 65
Incidence of Serious Adverse Events (SAEs)
Measured: Baseline Day -1 to Day 65
Severity of all All Adverse Events (AEs)
Measured: Baseline Day -1 to Day 65
Change from baseline in electrocardiogram(ECG) results
Measured: Baseline Day -1 to Day 35
Change from baseline in body temperature
Measured: Baseline Day -1 to Day 35
Change from baseline in respiratory rate
Measured: Baseline Day -1 to Day 35
Change from baseline in seated blood pressure
Measured: Baseline Day -1 to Day 35
Change from baseline in heart rate
Measured: Baseline Day -1 to Day 35
Change from baseline in clinical laboratory test results
Clinical laboratory testing to include Chemistry analytes and Hematology analytes.
Measured: Baseline Day -1 to Day 35
Change from baseline in continuous cardiac monitoring data
Measured: Baseline Day -1 to Day 35
Change from baseline in physical examination findings
Measured: Baseline Day -1 to Day 35
Secondary outcomes (10)
Mean difference in nadir heart rate (HR) and its time-matched HR on Day -1
Measured: Day -1 to Day 4
Largest decrease in HR from time-matched Day -1 baseline
Measured: Day -1 to Day 4
Time to nadir HR from time 0 hour (predose)
Measured: Day -1 to Day 4
Percent reduction in HR at nadir from time-matched Day -1 HR value
Measured: Day -1 to Day 4
Mean change from baseline in HR values by timepoint for BMS-986166-treated versus placebo-treated subjects where the baseline is defined as time-matched Day -1 HR value
Measured: Day -1 to Day 7
Mean difference in absolute lymphocyte count (ALC) values and its time-matched ALC on Day -1 in BMS-986166- treated versus placebo-treated subjects
Measured: Day -1 to Day 4
Largest decrease in ALC from time-matched Day -1 baseline
Measured: Day -1 to Day 4
Time to nadir ALC from time 0 hour (predose)
Measured: Day -1 to Day 4
Percent reduction in ALC at nadir from time-matched Day -1 value
Measured: Day -1 to Day 4
Mean change from baseline in ALC values by timepoint for BMS-986166-treated versus placebo-treated subjects where the baseline is defined as time-matched Day -1 ALC value
Measured: Day -1 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study start28 Jul 2016
- Primary completion7 Nov 2017
- Study completion7 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
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
- NCT02790125
- Sponsor's protocol ID
- IM018-001
- Status last verified
- Nov 2017
- First submitted
- 31 May 2016
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Singhal S, Girgis IG, Xie J, Dutta S, Shevell DE, Throup J. The safety and pharmacokinetics of a novel, selective S1P1R modulator in healthy participants. Expert Opin Investig Drugs. 2020 Apr;29(4):411-422. doi: 10.1080/13543784.2020.1742322.
PubMed 32306792
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02790125
- Acronym / sponsor ID
- IM018-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2016 (actual)
- Primary completion
- 7 Nov 2017 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 3 Jun 2016 (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.
The primary purpose of this study is to determine if single doses of BMS-986166 are safe and well tolerated in healthy male subjects and female subjects of non-childbearing potential.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose Panel 1 | Experimental | Drug: BMS-986166, Drug: Placebo matching BMS-986166BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified |
| Dose Panel 2 | Experimental | Drug: BMS-986166, Drug: Placebo matching BMS-986166BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified |
| Dose Panel 3 | Experimental | Drug: BMS-986166, Drug: Placebo matching BMS-986166BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified |
| Dose Panel 4 | Experimental | Drug: BMS-986166, Drug: Placebo matching BMS-986166BMS-986166 or Placebo matching BMS-986166 Multiple ascending solid dose formulation as specified |
| Dose Panel 5a/b/c | Experimental | Drug: BMS-986166BMS-986166 Single oral solid dose formulation under fasting/fed/fasting with famotidine conditions |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy female subjects of non-childbearing potential or male subjects as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations
- Ages 18 to 55 years
- Female subjects must provide documentation of an acceptable method of surgical sterilization or meet the protocol criteria for menopause
Key exclusion criteria (6 listed)
- Any acute or chronic medical illness judged to be clinically significant by the Investigator and/or Sponsor medical monitor
- Any acute or chronic bacterial, fungal or viral infection, including tuberculosis, HIV, hepatitis B or hepatitis C, as defined in the protocol
- History of heart disease, neurological disease, eye disorders or gastrointestinal disorders or surgery (including cholecystectomy)
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs or clinical laboratory tests
- Smoking or nicotine use, drug or alcohol abuse within 6 months of starting the 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 |
|---|---|---|
| BMS-986166 | Drug | Dose Panel 1, Dose Panel 2, Dose Panel 3, Dose Panel 4, Dose Panel 5a/b/c |
| Placebo matching BMS-986166 | Drug | Dose Panel 1, Dose Panel 2, Dose Panel 3, Dose Panel 4 |
Primary outcome
Incidence of All Adverse Events (AEs)
Time frame: Baseline Day -1 to Day 65
Incidence of Serious Adverse Events (SAEs)
Time frame: Baseline Day -1 to Day 65
Severity of all All Adverse Events (AEs)
Time frame: Baseline Day -1 to Day 65
Change from baseline in electrocardiogram(ECG) results
Time frame: Baseline Day -1 to Day 35
Change from baseline in body temperature
Time frame: Baseline Day -1 to Day 35
Change from baseline in respiratory rate
Time frame: Baseline Day -1 to Day 35
Change from baseline in seated blood pressure
Time frame: Baseline Day -1 to Day 35
Change from baseline in heart rate
Time frame: Baseline Day -1 to Day 35
Change from baseline in clinical laboratory test results
Time frame: Baseline Day -1 to Day 35
Clinical laboratory testing to include Chemistry analytes and Hematology analytes.
Change from baseline in continuous cardiac monitoring data
Time frame: Baseline Day -1 to Day 35
Change from baseline in physical examination findings
Time frame: Baseline Day -1 to Day 35
10 secondary outcomes
Mean difference in nadir heart rate (HR) and its time-matched HR on Day -1
Time frame: Day -1 to Day 4
Largest decrease in HR from time-matched Day -1 baseline
Time frame: Day -1 to Day 4
Time to nadir HR from time 0 hour (predose)
Time frame: Day -1 to Day 4
Percent reduction in HR at nadir from time-matched Day -1 HR value
Time frame: Day -1 to Day 4
Mean change from baseline in HR values by timepoint for BMS-986166-treated versus placebo-treated subjects where the baseline is defined as time-matched Day -1 HR value
Time frame: Day -1 to Day 7
Mean difference in absolute lymphocyte count (ALC) values and its time-matched ALC on Day -1 in BMS-986166- treated versus placebo-treated subjects
Time frame: Day -1 to Day 4
Largest decrease in ALC from time-matched Day -1 baseline
Time frame: Day -1 to Day 4
Time to nadir ALC from time 0 hour (predose)
Time frame: Day -1 to Day 4
Percent reduction in ALC at nadir from time-matched Day -1 value
Time frame: Day -1 to Day 4
Mean change from baseline in ALC values by timepoint for BMS-986166-treated versus placebo-treated subjects where the baseline is defined as time-matched Day -1 ALC value
Time frame: Day -1 to Day 7
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 24 Nov 2017.
- Derived from this study: PubMed 32306792Singhal S, Girgis IG, Xie J, Dutta S, Shevell DE, Throup J. The safety and pharmacokinetics of a novel, selective S1P1R modulator in healthy participants. Expert Opin Investig Drugs. 2020 Apr;29(4):411-422. doi: 10.1080/13543784.2020.1742322.
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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.
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, 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 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 24 Nov 2017. 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. 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?
Incidence of All Adverse Events (AEs) (time frame: Baseline Day -1 to Day 65). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02790125, which also lists 1 linked publication.
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 24 Nov 2017; AzTrials last refreshed its copy on 5 Nov 2026.