FibrosisPhase 1NCT03142165
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants
A Phase 1 study testing BMS-986263, Diphenhydramine and Famotidine in people with Fibrosis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of BMS-986263 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibrosis
- What is being tested?
- BMS-986263, Diphenhydramine and Famotidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2017to 29 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 participants as determined by no clinically significant deviation from normal in medical history, physical exam, ECGs, and clinical laboratory determinations
- Weight within the range of ≥60 and ≤90 kg
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug
- WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986263 (21 days), plus 5 half-lives of BMS-986263 (7.5 days) plus 30 days (duration of ovulatory cycle) for a total of 90 days post-treatment completion
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986263 (21 days) plus 5 half-lives of BMS-986263 (7.5 days) plus the duration of sperm turnover (90 days) for a total of 118.5 days post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements
Who cannot join
- History or evidence of active infection and/or febrile illness within 7 days of Study Day 1 (e.g., bronchopulmonary, urinary, gastrointestinal, etc.)
- History of serious bacterial, fungal, or viral infections that let to hospitalization and IV antibiotic treatment within 90 days prior to screening, or any recent serious infection requiring antibiotic treatment within 30 days of Study Day 1
- History of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection, or skin infection (recurrent or chronic infection is defined as ≥2 episodes within a 6 month period)
- Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history)
- History of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Presence of active tuberculosis (TB), latent TB, or inadequately treated latent or active TB
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants
The purpose of this study is to assess the safety and tolerability of BMS-986263 in healthy volunteers.
- Conditions
- Fibrosis
- Being tested
- BMS-986263, Placebo, Diphenhydramine, Famotidine
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986263Drug
3 weekly doses of 90 mg infused intravenous administration
PlaceboOther
Placebo
DiphenhydramineDrug
50 mg intravenous administration
FamotidineDrug
20 mg intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| BMS-986263 | Experimental | Not described Receives: Drug: BMS-986263; Drug: Diphenhydramine; Drug: Famotidine |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo; Drug: Diphenhydramine; Drug: Famotidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE)
measured by incidences
Measured: 28 days
Serious Adverse Events (SAE)
measured by incidences
Measured: 30 days
Infusion related reactions
measured by incidences
Measured: 28 days
Abnormalities in clinical laboratory tests
measured by incidences
Measured: 28 days
Abnormal vital sign measurements
measured by incidences
Measured: 28 days
Abnormal electrocardiogram measurements
measured by incidences
Measured: 28 days
Physical examination abnormalities
measured by incidences
Measured: 28 days
Secondary outcomes (10)
Cmax
Maximum observed plasma concentration
Measured: 28 days
Tmax
Time of maximum observed plasma concentration
Measured: 28 days
AUC(0-T)
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration
Measured: 28 days
AUC(TAU)
Area under the concentration-time curve in one dosing interval (multiple dose only)
Measured: 28 days
T-HALF
Terminal phase half-life
Measured: 28 days
CLT
Total body clearance after IV dose
Measured: 28 days
AI_AUC
Accumulation Index, the ratio of AUC(TAU) at steady-state to that after the first dose (Day 15 only)
Measured: 28 days
T-HALFeff_AUC
Effective elimination half-life that explains the degree of accumulation observed for AUC(TAU) (Day 15 only)
Measured: 28 days
Ctrough
Trough observed plasma concentration
Measured: 28 days
Comparison of pharmacokinetic (PK) parameters in non-Japanese versus Japanese patients
Investigation of population specific differences in PK
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start11 May 2017
- Primary completion29 Nov 2017
- Study completion29 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibrosisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 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
- NCT03142165
- Sponsor's protocol ID
- IM025-001
- Status last verified
- Jan 2018
- First submitted
- 3 May 2017
- Last updated
- 12 Jan 2018
- 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 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants
- ClinicalTrials.gov ID
- NCT03142165
- Acronym / sponsor ID
- IM025-001
- Conditions
- Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 11 May 2017 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 5 May 2017 (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 assess the safety and tolerability of BMS-986263 in healthy volunteers.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMS-986263 | Experimental | Drug: BMS-986263, Drug: Diphenhydramine, Drug: Famotidine |
| Placebo | Placebo comparator | Other: Placebo, Drug: Diphenhydramine, Drug: Famotidine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy participants as determined by no clinically significant deviation from normal in medical history, physical exam, ECGs, and clinical laboratory determinations
- Weight within the range of ≥60 and ≤90 kg
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug
- WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986263 (21 days), plus 5 half-lives of BMS-986263 (7.5 days) plus 30 days (duration of ovulatory cycle) for a total of 90 days post-treatment completion
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986263 (21 days) plus 5 half-lives of BMS-986263 (7.5 days) plus the duration of sperm turnover (90 days) for a total of 118.5 days post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements
Key exclusion criteria (7 listed)
- History or evidence of active infection and/or febrile illness within 7 days of Study Day 1 (e.g., bronchopulmonary, urinary, gastrointestinal, etc.)
- History of serious bacterial, fungal, or viral infections that let to hospitalization and IV antibiotic treatment within 90 days prior to screening, or any recent serious infection requiring antibiotic treatment within 30 days of Study Day 1
- History of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection, or skin infection (recurrent or chronic infection is defined as ≥2 episodes within a 6 month period)
- Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history)
- History of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
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-9862633 weekly doses of 90 mg infused intravenous administration | Drug | BMS-986263 |
| PlaceboPlacebo | Other | Placebo |
| Diphenhydramine50 mg intravenous administration | Drug | BMS-986263, Placebo |
| Famotidine20 mg intravenous administration | Drug | BMS-986263, Placebo |
Primary outcome
Adverse Events (AE)
Time frame: 28 days
measured by incidences
Serious Adverse Events (SAE)
Time frame: 30 days
measured by incidences
Infusion related reactions
Time frame: 28 days
measured by incidences
Abnormalities in clinical laboratory tests
Time frame: 28 days
measured by incidences
Abnormal vital sign measurements
Time frame: 28 days
measured by incidences
Abnormal electrocardiogram measurements
Time frame: 28 days
measured by incidences
Physical examination abnormalities
Time frame: 28 days
measured by incidences
10 secondary outcomes
Cmax
Time frame: 28 days
Tmax
Time frame: 28 days
AUC(0-T)
Time frame: 28 days
AUC(TAU)
Time frame: 28 days
T-HALF
Time frame: 28 days
CLT
Time frame: 28 days
AI_AUC
Time frame: 28 days
T-HALFeff_AUC
Time frame: 28 days
Ctrough
Time frame: 28 days
Comparison of pharmacokinetic (PK) parameters in non-Japanese versus Japanese patients
Time frame: 28 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 12 Jan 2018.
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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-986263, Diphenhydramine and Famotidine in people with Fibrosis, 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 5 inclusion and 7 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 12 Jan 2018. 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?
Adverse Events (AE) (time frame: 28 days). The study lists 7 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 12 Jan 2018.