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BMS-986020 · 5 trials · 4 indications
FVC is the is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry; and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes.
Pharmacokinetic endpoints for montelukast, flurbiprofen, and digoxin with and without BMS-986020
The following safety endpoints will be considered, the incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation from the study, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, electrocardiograms (ECGs), and physical examinations occurring from screening up to study discharge.
Assessed by \[11C\]BMT-136088 tracer lung volume of distribution (VT) before and after single oral dose of BMS-986020.
| Arm | Type | Description |
|---|---|---|
| Arm 1: BMS 986020, 600 mg. once daily | EXPERIMENTAL | BMS-986020, 600 mg tablets, by mouth, once daily, 26 weeks |
| Arm 2: BMS-986020, 600 mg twice daily | EXPERIMENTAL | BMS-986020, 600 mg tablets, by mouth, twice daily, 26 weeks |
| Arm 3: Placebo matching with BMS-986020 | PLACEBO_COMPARATOR | Placebo, 0 mg tablets, by mouth, twice daily, 26 weeks |
| Single-Sequence, A B C | EXPERIMENTAL | Treatment A: Single oral dose of montelukast, flurbiprofen, and digoxin on Day 1 Treatment B: BMS-986020 orally twice daily (BID) on Day 8 through Day 10 Treatment C: BMS-986020 orally BID, single oral dose of montelukast, flurbiprofen, and digoxin on Day 11; BMS-986020 BID on Day 12 through Day 17 |
| Arm A - BMS-986020 | EXPERIMENTAL | 600 mg (approximately 80 micro Curie) of \[14C\] BMS-986020 Single Dose for 1 Day (Day 1) orally |
| BMS-986020 + Rosuvastatin (Treatment A, B and C) | EXPERIMENTAL | Cohort 1: Rosuvastatin Tablet Single dose and BMS- 986020 orally on specific days Cohort 2 (Administered 4 hrs, after the morning dose of BMS-986020): Rosuvastatin Tablet Single dose and BMS- 986020 orally on specific days |
| Part 1: [11C]BMT-136088 (Safety Study) | EXPERIMENTAL | Single PET SCAN with single bolus injection of \[11C\]BMT-136088 |
| Part 2: [11C]BMT-136088 (Test/Retest study) | EXPERIMENTAL | Single PET SCAN with Intravenous (IV) bolus plus infusion of \[11C\]BMT-136088 followed by a re-test PET scan (approximately 6 hours apart) with IV bolus plus infusion of \[11C\]BMT-136088 |
| Part 3: BMS-986020+[11C]BMT-136088 (Receptor Occupancy study) | EXPERIMENTAL | BMS-986020 Tablets or Oral Solution of 4 dose levels from from the 6 dose levels of (50 mg, 150 mg, 300 mg, 600 mg, 1200 mg and 1500 mg) and 3 PET SCANS (Pre-Dose, Post-Dose1, Post-Dose2) with bolus plus infusion of \[11C\]BMT-136088 |
| Part 4: [11C]BMT-136088 (Tissue Distribution study) | EXPERIMENTAL | Single PET SCAN with \[11C\]BMT-136088 to evaluate additional tracer uptake sites in humans other than the lung, such as heart, kidney, liver, gallbladder, etc. |
| Name | Type | Description |
|---|---|---|
| BMS-986020 | DRUG | - |
| Placebo matching with BMS-986020 | DRUG | - |
| Montelukast | DRUG | - |
| Flurbiprofen | DRUG | - |
| Digoxin | DRUG | - |
| [14C] BMS-986020 | DRUG | - |
| Rosuvastatin | DRUG | - |
| [11C]BMT-136088 | DRUG | - |
Inclusion Criteria: * Are between the ages of 40 and 90 years, inclusive, at randomization. * Have clinical symptoms consistent with IPF. * Have first received a diagnosis of IPF less than 6 years before randomization. The date of diagnosis is defined as the date of the first available imaging or s...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | BMS-986278 |
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Treprostinil |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | ABBV-142 |
| PureTech Health PLC Sponsored ADR | PRTC | 2 | PHASE3 | Deupirfenidone, Pirfenidone |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Contineum Therapeutics, Inc. Class A | CTNM | 1 | PHASE2 | PIPE-791 Dose A, PIPE-791 Dose B |
| Rein Therapeutics, Inc | RNTX | 1 | PHASE2 | LTI-03 |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | HEC585, Pirfenidone |
| Cumberland Pharmaceuticals Inc. | CPIX | 1 | PHASE2 | Ifetroban |
| Avalyn Pharma Inc | AVLN | 3 | PHASE2 | AP01 |
BMS-986020 is an investigational small molecule being studied for idiopathic pulmonary fibrosis, immunosuppression for disease, drug-drug interaction studies, and immunology. It is in Phase 1 clinical development and has not been approved by the FDA. All completed trials involved healthy volunteers.
BMS-986020 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company has conducted Phase 1 clinical trials for this investigational small molecule, which is being studied for conditions including idiopathic pulmonary fibrosis and immunosuppression.
BMS-986020 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, and no active trials are currently listed for this asset.
BMS-986020 has completed four Phase 1 trials. NCT02017730 evaluated plasma drug levels and receptor binding in lung using PET in healthy volunteers. NCT02068053 was an ADME study. NCT02101125 studied drug interaction with rosuvastatin. NCT02227173 was a drug-drug interaction study.
BMS-986020 is the primary name used for this investigational small molecule. No alternative names have been reported for this asset, which is being developed by Bristol-Myers Squibb for idiopathic pulmonary fibrosis and other conditions.