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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: BMS-986278 + Sildenafil | Experimental |
| |
| Part 1: Placebo + Sildenafil | Placebo Comparator |
| |
| Part 2: BMS-986278 | Experimental |
| |
| Part 2: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986278 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean placebo-corrected change from baseline in systolic blood pressure (SBP) (Part 1) | Up to 16 days | |
| Maximum observed plasma concentration (Cmax) (Part 2) | Up to 14 days | |
| Time of maximum observed plasma concentration (Tmax) (Part 2) | 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) | Up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Part 1 and 2) | Up to 16 days | |
| Tmax (Part 1) | Up to 16 days | |
| AUC(0-T) (Part 1) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Clinical Los Angeles, Inc | Cypress | California | 90630 | United States | ||
| Syneos Health Clinical Research Services, Llc |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
| BMS Clinical Trial Patient Recruiting |
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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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| Sildenafil | Drug | Specified dose on specified days |
|
| Placebo | Drug | Specified dose on specified days |
|
| Up to 16 days |
| Number of participants with adverse events (AEs) (Part 1 and 2) | 30 days after last dose |
| Number of participants with serious adverse events (SAEs) (Part 1 and 2) | 30 days after last dose |
| Number of participants with clinical laboratory abnormalities (Part 1 and 2) | 30 days after last dose |
| Number of participants with physical examination abnormalities (Part 1 and 2) | 30 days after last dose |
| Number of participants with vital sign abnormalities (Part 1 and 2) | 30 days after last dose |
| Number of participants with electrocardiogram (ECG) abnormalities (Part 1 and 2) | 30 days after last dose |
| Mean placebo-corrected change in diastolic blood pressure (DBP) (Part 1) | 30 days after last dose |
| Area under the concentration-time curve in 1 dosing interval (AUC [TAU]) (Part 2) | Up to 14 days |
| Miami |
| Florida |
| 33136 |
| United States |
| Investigator Inquiry Form | View source |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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