Healthy ParticipantsPhase 1NCT04082741
A Single and Multiple Ascending Dose Study of BMS-986318 in Healthy Participants
A Phase 1 study testing BMS-986318 in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
A study to evaluate single and multiple ascending doses of experimental medicine BMS-986318 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BMS-986318
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2019to 12 Sep 2019
- 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 Participants as determined by no clinically significant deviations from normal in medical history, physical examination, ECG and clinical laboratory results as determined by the investigator
- Male participants who are sexually active with Women of Child Bearing Potential (WOCBP) must agree to follow instructions for methods of contraception for duration of treatment plus 92 days.
- Female participants must have documented proof that they are not of childbearing potential and a negative pregnancy test at screening and within 24 hours before the first dose of study treatment.
Who cannot join
- Use of any prescription drugs within 4 weeks or use of over-the-counter (OTC) medications or herbal preparations within 2 weeks prior to study treatment administration (except acid controllers, which are not allowed within 4 weeks prior to study treatment administration
- Women of Child Bearing Potential (WOCBP) or women who are breastfeeding.
- Any major surgery within 12 weeks of study administration Or any history of GI surgeries as listed.(eg, gastric bypass, gastric banding, Roux-en-Y) or gastric- emptying issues that could impact upon the absorption of nutrients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blind, Placebo-Controlled, Randomized Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of Oral BMS-986318 Administration in Healthy Participants
A study to evaluate single and multiple ascending doses of experimental medicine BMS-986318 in healthy participants.
Read the detailed description
A Phase 1, Double-Blind, Placebo-Controlled, Randomized Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of Oral BMS-986318 Administration in Healthy Participants
- Conditions
- Healthy Participants
- Being tested
- BMS-986318, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986318Drug
Specified dose on specified days
PlaceboOther
Placebo Matching BMS-986318
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy SAD BMS-986318 or Placebo | Experimental | Single Ascending Dose (SAD) Receives: Drug: BMS-986318; Other: Placebo |
| Monotherapy MAD BMS-986318 or Placebo | Experimental | Multiple Ascending Dose (MAD) Receives: Drug: BMS-986318; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of non-serious adverse events (AEs)
Measured: up to 30 days
Incidence of Serious Adverse Events (SAE)
Measured: up to 30 days
Incidence of AEs leading to discontinuation of study treatment
Measured: up to 30 days
Physical Examination of height
Measured: up to 30 days
Physical Examination of weight
Measured: up to 30 days
Physical Examination of BMI
Measured: up to 30 days
Assessment of body temperature
Measured: up to 30 days
Assessment of respiratory rate
Measured: up to 30 days
Assessment of blood pressure
Measured: up to 30 days
Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities
Measured: up to 30 days
Number of clinical significant changes in lab assessment of blood serum
Measured: up to 30 days
Number of Clinically significant changes in assessment of blood
Measured: up to 30 days
Number of Clinically significant changes in lab assessment of urine
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start18 Jul 2019
- Primary completion12 Sep 2019
- Study completion12 Sep 2019
Why it stopped: The study is no longer required based on nonclinical drug data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- 0 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
- NCT04082741
- Sponsor's protocol ID
- IM031-002
- Status last verified
- Jan 2020
- First submitted
- 15 Aug 2019
- Last updated
- 27 Jan 2020
- 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 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Placebo-Controlled, Randomized Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of Oral BMS-986318 Administration in Healthy Participants
- ClinicalTrials.gov ID
- NCT04082741
- Acronym / sponsor ID
- IM031-002
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study is no longer required based on nonclinical drug data
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 9 Sep 2019 (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.
A study to evaluate single and multiple ascending doses of experimental medicine BMS-986318 in healthy participants.
Detailed description
A Phase 1, Double-Blind, Placebo-Controlled, Randomized Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of Oral BMS-986318 Administration in Healthy Participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy SAD BMS-986318 or Placebo | Experimental | Drug: BMS-986318, Other: PlaceboSingle Ascending Dose (SAD) |
| Monotherapy MAD BMS-986318 or Placebo | Experimental | Drug: BMS-986318, Other: PlaceboMultiple Ascending Dose (MAD) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Participants as determined by no clinically significant deviations from normal in medical history, physical examination, ECG and clinical laboratory results as determined by the investigator
- Male participants who are sexually active with Women of Child Bearing Potential (WOCBP) must agree to follow instructions for methods of contraception for duration of treatment plus 92 days.
- Female participants must have documented proof that they are not of childbearing potential and a negative pregnancy test at screening and within 24 hours before the first dose of study treatment.
Key exclusion criteria (3 listed)
- Use of any prescription drugs within 4 weeks or use of over-the-counter (OTC) medications or herbal preparations within 2 weeks prior to study treatment administration (except acid controllers, which are not allowed within 4 weeks prior to study treatment administration
- Women of Child Bearing Potential (WOCBP) or women who are breastfeeding.
- Any major surgery within 12 weeks of study administration Or any history of GI surgeries as listed.(eg, gastric bypass, gastric banding, Roux-en-Y) or gastric- emptying issues that could impact upon the absorption of nutrients.
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-986318Specified dose on specified days | Drug | Monotherapy MAD BMS-986318 or Placebo, Monotherapy SAD BMS-986318 or Placebo |
| PlaceboPlacebo Matching BMS-986318 | Other | Monotherapy MAD BMS-986318 or Placebo, Monotherapy SAD BMS-986318 or Placebo |
Primary outcome
Incidence of non-serious adverse events (AEs)
Time frame: up to 30 days
Incidence of Serious Adverse Events (SAE)
Time frame: up to 30 days
Incidence of AEs leading to discontinuation of study treatment
Time frame: up to 30 days
Physical Examination of height
Time frame: up to 30 days
Physical Examination of weight
Time frame: up to 30 days
Physical Examination of BMI
Time frame: up to 30 days
Assessment of body temperature
Time frame: up to 30 days
Assessment of respiratory rate
Time frame: up to 30 days
Assessment of blood pressure
Time frame: up to 30 days
Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities
Time frame: up to 30 days
Number of clinical significant changes in lab assessment of blood serum
Time frame: up to 30 days
Number of Clinically significant changes in assessment of blood
Time frame: up to 30 days
Number of Clinically significant changes in lab assessment of urine
Time frame: up to 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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-986318 in people with Healthy Participants, 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 3 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: withdrawn, as of the sponsor's last update on 27 Jan 2020. 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 was withdrawn before enrolling participants, so there are no results.
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 non-serious adverse events (AEs) (time frame: up to 30 days). The study lists 13 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 27 Jan 2020.