Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nintedanib · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part I: Period A | EXPERIMENTAL | - |
| Part I: Period B | EXPERIMENTAL | - |
| Part I: Period C | EXPERIMENTAL | - |
| Part II: Period 1 | EXPERIMENTAL | - |
| Part II: Period 2 | EXPERIMENTAL | - |
| Part II: Period 3 | EXPERIMENTAL | - |
| Part III: Period 1 | EXPERIMENTAL | - |
| Part III: Period 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Nintedanib | DRUG | Specified Dose on specified days |
| BMS 986278 | DRUG | Specified dose on specified days |
Inclusion Criteria: * Participants must be healthy males and females (INOCBP) * Participant must have Body mass index (BMI) of 18.0 kg/m2 through 32.0 kg/m2, inclusive. * Participant must have Body weight ≥ 50 kg Exclusion Criteria: * Participant must not have current or recent GI disease * Parti...
Nintedanib is a small molecule being studied in healthy participants to assess drug interactions and bioavailability. A completed Phase 1 trial evaluated the extent of drug interaction between BMS-986278 and Nintedanib, the relative bioavailability of BMS-986278 in tablet form, and the effect of food on tablet formulations. It is investigational and not approved for this use.
Nintedanib targets multiple receptor tyrosine kinases, including PDGFRB, PDGFRA, FLT1, FLT4, KDR, FGFR3, FGFR1, FGFR4, and FGFR2. It acts as an inhibitor of these targets, which are involved in signaling pathways related to cell growth and angiogenesis.
Nintedanib is being developed by Bristol-Myers Squibb Company, traded under the ticker BMY. The company is conducting clinical research on the drug, including a Phase 1 trial in healthy participants.
Nintedanib is in Phase 1 clinical development. The single trial listed is a completed Phase 1 study with 71 participants. It is an investigational drug and has not been approved for any indication based on the available data.
Nintedanib has one completed clinical trial, NCT06568458, a Phase 1 study in healthy participants in the United States. The trial assessed drug interactions between BMS-986278 and Nintedanib, the relative bioavailability of BMS-986278 tablets, and the effect of food on tablet formulations. Enrollment was 71 participants.