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Also known as [14C] BMS-986020, Lysophosphatidic acid (LPA1) Antagonist
BMS-986020 · 4 trials · 3 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.
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 |
| 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 | - |
| [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...
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BMS-986020 is an investigational small molecule being studied for idiopathic pulmonary fibrosis, a progressive lung disease. It has also been evaluated in immunology and immunosuppression research settings. Bristol-Myers Squibb Company (BMY) developed the compound, which remains in clinical development and is not approved for any indication.
BMS-986020 targets LPAR1, the lysophosphatidic acid receptor 1, and acts as an antagonist. By blocking this receptor, the drug is designed to interfere with LPA-mediated signaling pathways that are thought to contribute to fibrosis and immune modulation. This mechanism underlies its study in idiopathic pulmonary fibrosis.
BMS-986020 is developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the clinical trials evaluating the compound in idiopathic pulmonary fibrosis and related immunology research.
BMS-986020 has completed Phase 2 clinical development. A Phase 2 trial in idiopathic pulmonary fibrosis enrolled 325 patients and has been completed. The drug is investigational and has not been approved by the FDA for any indication. No active trials are currently listed for this compound.
BMS-986020 has been studied in four completed clinical trials. The Phase 2 trial NCT01766817 evaluated safety and efficacy in idiopathic pulmonary fibrosis across the United States, Australia, Chile, Colombia, Mexico, and Peru. Phase 1 trials included NCT02101125, NCT02068053, and NCT02017730, which examined drug interactions, metabolism, and receptor binding.
Yes, [14C] BMS-986020 is an alternative name for BMS-986020. The [14C] label refers to a carbon-14 radiolabeled version of the compound used in absorption, distribution, metabolism, and excretion studies, such as the Phase 1 ADME trial NCT02068053.