Healthy ParticipantsPhase 1NCT05684289
A Study Investigating the Safety, Tolerability, Drug Levels and Drug Effect of BMS-986278 in Healthy Adult Participants (Part 1) and Japanese Participants (Part 2)
A Phase 1 study testing BMS-986278 and Sildenafil in people with Healthy Participants, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, drug levels and drug effect of BMS-986278 in healthy adult participants and Japanese participants. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BMS-986278 and Sildenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jan 2023to 2 May 2023
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants in the Japanese cohort (Part 2) must be first generation Japanese (born in Japan, not living outside of Japan > 10 years, both parents ethnically Japanese).
- Body mass index (BMI) of 18.0 kilogram (kg)/meter (m)^2 through 32.0 kg/m^2, inclusive. BMI = weight (kg)/(height [m])^2.
- Body weight ≥ 50 kg for males and ≥ 45 kg for females.
Who cannot join
- Any significant acute or chronic medical illness.
- Any gastrointestinal (GI) disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion.
- Any major surgery within 4 weeks of first study intervention administration.
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Altasciences Clinical Los Angeles, Inc
Cypress, California, 90630
Syneos Health Clinical Research Services, Llc
Miami, Florida, 33136
About this study
Official title: A Phase 1, 2-Part, Randomized, Double-Blind, Placebo-controlled, Multiple Dose Study to Test the Potential Interaction of a PDE5 Inhibitor With BMS-986278 and to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986278 in Healthy Adult Participants (Part 1) and in Japanese Participants (Part 2)
The purpose of this study is to evaluate the safety, tolerability, drug levels and drug effect of BMS-986278 in healthy adult participants and Japanese participants.
- Conditions
- Healthy Participants
- Being tested
- BMS-986278, Sildenafil, Placebo
- Keywords
- BMS-986278, Idiopathic Pulmonary Fibrosis (IPF), Sildenafil
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986278Drug
Specified dose on specified days
SildenafilDrug
Specified dose on specified days
PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1: BMS-986278 + Sildenafil | Experimental | Not described Receives: Drug: BMS-986278; Drug: Sildenafil |
| Part 1: Placebo + Sildenafil | Placebo comparator | Not described Receives: Drug: Sildenafil; Drug: Placebo |
| Part 2: BMS-986278 | Experimental | Not described Receives: Drug: BMS-986278 |
| Part 2: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean placebo-corrected change from baseline in systolic blood pressure (SBP) (Part 1)
Measured: Up to 16 days
Maximum observed plasma concentration (Cmax) (Part 2)
Measured: Up to 14 days
Time of maximum observed plasma concentration (Tmax) (Part 2)
Measured: Up to 14 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) (Part 2)
Measured: Up to 14 days
Secondary outcomes (11)
Cmax (Part 1 and 2)
Measured: Up to 16 days
Tmax (Part 1)
Measured: Up to 16 days
AUC(0-T) (Part 1)
Measured: Up to 16 days
Number of participants with adverse events (AEs) (Part 1 and 2)
Measured: 30 days after last dose
Number of participants with serious adverse events (SAEs) (Part 1 and 2)
Measured: 30 days after last dose
Number of participants with clinical laboratory abnormalities (Part 1 and 2)
Measured: 30 days after last dose
Number of participants with physical examination abnormalities (Part 1 and 2)
Measured: 30 days after last dose
Number of participants with vital sign abnormalities (Part 1 and 2)
Measured: 30 days after last dose
Number of participants with electrocardiogram (ECG) abnormalities (Part 1 and 2)
Measured: 30 days after last dose
Mean placebo-corrected change in diastolic blood pressure (DBP) (Part 1)
Measured: 30 days after last dose
Area under the concentration-time curve in 1 dosing interval (AUC [TAU]) (Part 2)
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start3 Jan 2023
- Primary completion2 May 2023
- Study completion2 May 2023
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 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
- NCT05684289
- Sponsor's protocol ID
- IM027-1017
- Status last verified
- Aug 2023
- First submitted
- 20 Dec 2022
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 2-Part, Randomized, Double-Blind, Placebo-controlled, Multiple Dose Study to Test the Potential Interaction of a PDE5 Inhibitor With BMS-986278 and to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986278 in Healthy Adult Participants (Part 1) and in Japanese Participants (Part 2)
- ClinicalTrials.gov ID
- NCT05684289
- Acronym / sponsor ID
- IM027-1017
- Conditions
- Healthy Participants
- Keywords
- BMS-986278, Idiopathic Pulmonary Fibrosis (IPF), Sildenafil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 13 Jan 2023 (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 effect of BMS-986278 in healthy adult participants and Japanese participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: BMS-986278 + Sildenafil | Experimental | Drug: BMS-986278, Drug: Sildenafil |
| Part 1: Placebo + Sildenafil | Placebo comparator | Drug: Sildenafil, Drug: Placebo |
| Part 2: BMS-986278 | Experimental | Drug: BMS-986278 |
| Part 2: Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants in the Japanese cohort (Part 2) must be first generation Japanese (born in Japan, not living outside of Japan > 10 years, both parents ethnically Japanese).
- Body mass index (BMI) of 18.0 kilogram (kg)/meter (m)^2 through 32.0 kg/m^2, inclusive. BMI = weight (kg)/(height [m])^2.
- Body weight ≥ 50 kg for males and ≥ 45 kg for females.
Key exclusion criteria (4 listed)
- Any significant acute or chronic medical illness.
- Any gastrointestinal (GI) disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion.
- Any major surgery within 4 weeks of first study intervention administration.
- 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-986278Specified dose on specified days | Drug | Part 1: BMS-986278 + Sildenafil, Part 2: BMS-986278 |
| SildenafilSpecified dose on specified days | Drug | Part 1: BMS-986278 + Sildenafil, Part 1: Placebo + Sildenafil |
| PlaceboSpecified dose on specified days | Drug | Part 1: Placebo + Sildenafil, Part 2: Placebo |
Primary outcome
Mean placebo-corrected change from baseline in systolic blood pressure (SBP) (Part 1)
Time frame: Up to 16 days
Maximum observed plasma concentration (Cmax) (Part 2)
Time frame: Up to 14 days
Time of maximum observed plasma concentration (Tmax) (Part 2)
Time frame: Up to 14 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) (Part 2)
Time frame: Up to 14 days
11 secondary outcomes
Cmax (Part 1 and 2)
Time frame: Up to 16 days
Tmax (Part 1)
Time frame: Up to 16 days
AUC(0-T) (Part 1)
Time frame: Up to 16 days
Number of participants with adverse events (AEs) (Part 1 and 2)
Time frame: 30 days after last dose
Number of participants with serious adverse events (SAEs) (Part 1 and 2)
Time frame: 30 days after last dose
Number of participants with clinical laboratory abnormalities (Part 1 and 2)
Time frame: 30 days after last dose
Number of participants with physical examination abnormalities (Part 1 and 2)
Time frame: 30 days after last dose
Number of participants with vital sign abnormalities (Part 1 and 2)
Time frame: 30 days after last dose
Number of participants with electrocardiogram (ECG) abnormalities (Part 1 and 2)
Time frame: 30 days after last dose
Mean placebo-corrected change in diastolic blood pressure (DBP) (Part 1)
Time frame: 30 days after last dose
Area under the concentration-time curve in 1 dosing interval (AUC [TAU]) (Part 2)
Time frame: Up to 14 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 24 Aug 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- Individual participant dataSharing planned: No. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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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
2 sites 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-986278 and Sildenafil in people with Healthy Participants, run by Bristol-Myers Squibb at 2 sites 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 4 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 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Mean placebo-corrected change from baseline in systolic blood pressure (SBP) (Part 1) (time frame: Up to 16 days). The study lists 4 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 24 Aug 2023.