Ulcerative ColitisPhase 1NCT03038711
A Multiple Dose Study to Assess the Safety and Tolerability of BMS-986166 in Healthy Volunteers
A Phase 1 study testing BMS-986166 in people with Ulcerative Colitis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to understand if multiple oral doses of BMS-986166 are safe and well tolerated in healthy patients. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- BMS-986166
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 10 Aug 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 patients of non-childbearing potential or male patients as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study
- Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive
- This study permits the re-enrollment of a patient that has discontinued the study as a pre-treatment failure (i.e. patient has not been randomized / has not been treated). If re-enrolled, the patient must be re-consented
Who cannot join
- Women who are of childbearing potential, lactating or breastfeeding
- Any significant acute or chronic medical illness judged to be clinically significant by the Investigator and/or Sponsor medical monitor
- Patients with history of any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant ECG abnormalities, or any congenital heart disease
- Patients with any acute or chronic bacterial, fungal (except history of tinea pedis or ongoing onychomycosis will not be exclusionary) or viral infection within the last 3 months prior to screening, as well as any febrile illness or viral infection within the last 3 months prior to screening, as well as any febrile illness of unknown origin within 14 days of screening
- Patients who have received any live vaccines within 1 month of study drug administration, or who plan to have a live vaccine at any time during the study, including during the follow up period
- Positive test for tuberculosis at screening
- Past or current history of neurologic disorders, Guillain-Barré Syndrome, central or peripheral neuropathies, or past or current symptoms of sustained or recurrent paresthesia's (tingling), numbness, or neuropathic pain (burning, aching or stabbing) in any extremities
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects
The purpose of this study is to understand if multiple oral doses of BMS-986166 are safe and well tolerated in healthy patients.
- Conditions
- Ulcerative Colitis
- Being tested
- BMS-986166, Placebo matching BMS-986166
- Medical subject headings
- Colitis, Ulcerative
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
Placebo matching BMS-986166Other
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Dose Panel 1 | Experimental | BMS-986166 or Placebo matching BMS-986166 Receives: Drug: BMS-986166; Other: Placebo matching BMS-986166 |
| Dose Panel 2 | Experimental | BMS-986166 or Placebo matching BMS-986166 Receives: Drug: BMS-986166; Other: Placebo matching BMS-986166 |
| Dose Panel 3 | Experimental | BMS-986166 or Placebo matching BMS-986166 Receives: Drug: BMS-986166; Other: Placebo matching 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 by number of patients
Measured: 77 days
Incidence of Serious Adverse Events (SAEs)
measured by number of patients
Measured: 77 days
Severity of all Adverse Events (AEs)
measured by investigator
Measured: 77 days
Change from baseline in physical examination findings
measured by investigator
Measured: 77 days
Change from baseline in electrocardiogram (ECG) results
measured by ECG
Measured: 77 days
Change from baseline in continuous cardiac monitoring data
measured with external monitoring device
Measured: 15 days
Change from baseline in clinical laboratory test results
measured by serum chemistry, hematology, serology and urinalysis results
Measured: 77 days
Change from baseline in body temperature
measured in degrees Celsius or Fahrenheit
Measured: 77 days
Change from baseline in respiratory rate
measured by investigator
Measured: 77 days
Change from baseline in seated blood pressure
measured by investigator
Measured: 77 days
Change from baseline in heart rate
measured by investigator
Measured: 77 days
Secondary outcomes (18)
Mean heart rate (HR)
Calculated from nadir HR to time-matched HR on Day -1
Measured: 15 days
Largest decrease in HR from time-matched Day -1 baseline
measured by investigator
Measured: 15 days
Time to nadir HR from time 0 hour (predose)
measured by investigator
Measured: 15 days
Time to largest decrease HR from time 0 hour (predose)
measured by investigator
Measured: 15 days
Mean change from baseline in HR values by timepoint for BMS-986166-treated versus placebo-treated patients where the baseline is defined as time-matched Day -1 HR value
measured by investigator
Measured: 15 days
Largest percent decrease in absolute lymphocyte count (ALC) from time-matched Day -1 baseline
measured by ALC
Measured: 35 days
Time to largest percent reduction ALC from time 0 hour (predose)
measured by ALC
Measured: 35 days
Mean percent change from baseline in ALC values by timepoint for BMS-986166-treated versus placebo-treated patients where the baseline is defined as time-matched Day -1 ALC value
measured by ALC
Measured: 77 days
Maximum observed blood concentration (Cmax)
measured by blood concentration versus time data
Measured: 77 days
Time of maximum observed blood concentration (Tmax)
measured by blood concentration versus time data
Measured: 77 days
Terminal half-life (T-HALF)
measured by blood concentration versus time data
Measured: 77 days
Area under the blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
measured by blood concentration versus time data
Measured: 77 days
Area under the blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
measured by blood concentration versus time data
Measured: 77 days
Apparent total clearance (CLT/F)
measured by blood concentration versus time data
Measured: 77 days
Apparent steady state volume (Vz/F)
measured by blood concentration versus time data
Measured: 77 days
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter
Measured: 77 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter
Measured: 77 days
Maximum observed concentration (Cmax)
Used to calculate metabolite to parent molar ratio of pharmacokinetic parameter
Measured: 77 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start1 Feb 2017
- Primary completion10 Aug 2017
- Study completion10 Aug 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 Ulcerative ColitisStudies 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
- 213 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
- NCT03038711
- Sponsor's protocol ID
- IM018-003
- Status last verified
- Jan 2019
- First submitted
- 26 Jan 2017
- Last updated
- 30 Jan 2019
- 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 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03038711
- Acronym / sponsor ID
- IM018-003
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 10 Aug 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 1 Feb 2017 (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 purpose of this study is to understand if multiple oral doses of BMS-986166 are safe and well tolerated in healthy patients.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Panel 1 | Experimental | Drug: BMS-986166, Other: Placebo matching BMS-986166BMS-986166 or Placebo matching BMS-986166 |
| Dose Panel 2 | Experimental | Drug: BMS-986166, Other: Placebo matching BMS-986166BMS-986166 or Placebo matching BMS-986166 |
| Dose Panel 3 | Experimental | Drug: BMS-986166, Other: Placebo matching BMS-986166BMS-986166 or Placebo matching BMS-986166 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy female patients of non-childbearing potential or male patients as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study
- Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive
- This study permits the re-enrollment of a patient that has discontinued the study as a pre-treatment failure (i.e. patient has not been randomized / has not been treated). If re-enrolled, the patient must be re-consented
Key exclusion criteria (8 listed)
- Women who are of childbearing potential, lactating or breastfeeding
- Any significant acute or chronic medical illness judged to be clinically significant by the Investigator and/or Sponsor medical monitor
- Patients with history of any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant ECG abnormalities, or any congenital heart disease
- Patients with any acute or chronic bacterial, fungal (except history of tinea pedis or ongoing onychomycosis will not be exclusionary) or viral infection within the last 3 months prior to screening, as well as any febrile illness or viral infection within the last 3 months prior to screening, as well as any febrile illness of unknown origin within 14 days of screening
- Patients who have received any live vaccines within 1 month of study drug administration, or who plan to have a live vaccine at any time during the study, including during the follow up period
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 | Dose Panel 1, Dose Panel 2, Dose Panel 3 |
| Placebo matching BMS-986166Specified dose on specified days | Other | Dose Panel 1, Dose Panel 2, Dose Panel 3 |
Primary outcome
Incidence of All Adverse Events (AEs)
Time frame: 77 days
measured by number of patients
Incidence of Serious Adverse Events (SAEs)
Time frame: 77 days
measured by number of patients
Severity of all Adverse Events (AEs)
Time frame: 77 days
measured by investigator
Change from baseline in physical examination findings
Time frame: 77 days
measured by investigator
Change from baseline in electrocardiogram (ECG) results
Time frame: 77 days
measured by ECG
Change from baseline in continuous cardiac monitoring data
Time frame: 15 days
measured with external monitoring device
Change from baseline in clinical laboratory test results
Time frame: 77 days
measured by serum chemistry, hematology, serology and urinalysis results
Change from baseline in body temperature
Time frame: 77 days
measured in degrees Celsius or Fahrenheit
Change from baseline in respiratory rate
Time frame: 77 days
measured by investigator
Change from baseline in seated blood pressure
Time frame: 77 days
measured by investigator
Change from baseline in heart rate
Time frame: 77 days
measured by investigator
18 secondary outcomes
Mean heart rate (HR)
Time frame: 15 days
Largest decrease in HR from time-matched Day -1 baseline
Time frame: 15 days
Time to nadir HR from time 0 hour (predose)
Time frame: 15 days
Time to largest decrease HR from time 0 hour (predose)
Time frame: 15 days
Mean change from baseline in HR values by timepoint for BMS-986166-treated versus placebo-treated patients where the baseline is defined as time-matched Day -1 HR value
Time frame: 15 days
Largest percent decrease in absolute lymphocyte count (ALC) from time-matched Day -1 baseline
Time frame: 35 days
Time to largest percent reduction ALC from time 0 hour (predose)
Time frame: 35 days
Mean percent change from baseline in ALC values by timepoint for BMS-986166-treated versus placebo-treated patients where the baseline is defined as time-matched Day -1 ALC value
Time frame: 77 days
Maximum observed blood concentration (Cmax)
Time frame: 77 days
Time of maximum observed blood concentration (Tmax)
Time frame: 77 days
Terminal half-life (T-HALF)
Time frame: 77 days
Area under the blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: 77 days
Area under the blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: 77 days
Apparent total clearance (CLT/F)
Time frame: 77 days
Apparent steady state volume (Vz/F)
Time frame: 77 days
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time frame: 77 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Time frame: 77 days
Maximum observed concentration (Cmax)
Time frame: 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 30 Jan 2019.
- 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 Ulcerative Colitis, 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 8 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 30 Jan 2019. 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: 77 days). 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 NCT03038711, 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 30 Jan 2019.