Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CC-99677
BMS-986371 · 6 trials · 3 indications
Part 1
Part 1
Part 1
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
The area under the curve (AUC) for the defined interval between doses (TAU)
The area under the curve (AUC) from the time of dosing to the last measurable concentration
Maximum observed plasma concentration occurring at Tmax
The time of maximum observed concentration sampled during a dosing interval
Terminal half-life
The total body clearance for extravascular administration divided by the fraction of dose absorbed, calculated using the observed value of the last non-zero concentration
The volume of distribution associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed, calculated using the observed value of the last non-zero concentration
Maximum observed plasma concentration
Area under the plasma concentration-time curve from time zero extrapolated to the last quantifiable concentration
Number of subjects with adverse events
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | - |
| Part 2 | EXPERIMENTAL | - |
| CC-99677 | EXPERIMENTAL | - |
| Administration of Dose A of CC-99677 or Placebo | EXPERIMENTAL | Administration of Dose A of CC-99677 or Placebo |
| Administration of Dose B of CC-99677 or Placebo | EXPERIMENTAL | Administration of Dose B of CC-99677 or Placebo |
| Administration of Dose C of CC-99677 or Placebo | EXPERIMENTAL | Administration of Dose C of CC-99677 or Placebo |
| Administration of OC alone, then progress to OC in combination with CC-99677 | EXPERIMENTAL | Oral Contraceptive (OC) and CC-99677 will be administered daily |
| Part 1: CC-99677 with Methotrexate and Sulfasalazine | EXPERIMENTAL | Fixed-sequence involving CC-99677 + Methotrexate 7.5 mg and sulfasalazine 1000 mg |
| Part 2: CC-99677 with Itraconazole and Rifampin | EXPERIMENTAL | Fixed-sequence involving CC-99677 + Rifampin 600 mg and Itraconazole 200 mg |
| Part 3: CC-99677, Midazolam, Digoxin, Metformin, Rosuvastatin | EXPERIMENTAL | Fixed-sequence involving CC-99677 + Midazolam 2 mg, Digoxin 0.25 mg, Metformin 500 mg, and Rosuvastatin 10 mg. |
| CC-99677 Under Fasted Conditions | EXPERIMENTAL | CC-99677 Under Fasted Conditions |
| Placebo | EXPERIMENTAL | Placebo under fasted conditions |
| CC-99677 Under Fed Conditions | EXPERIMENTAL | CC-99677 Under Fed Conditions |
| Name | Type | Description |
|---|---|---|
| Methotrexate | DRUG | Specified dose on specified days |
| Leucovorin | DRUG | Specified dose on specified days |
| BMS-986371 | DRUG | Specified dose on specified days |
| Sulfasalazine | DRUG | Specified dose on specified days |
| CC-99677 | DRUG | Specified dose on specified days |
| Placebo | OTHER | Placebo |
| Oral Contraceptive (Ortho Tri-Cyclen or its generic equivalent) | DRUG | Daily |
| Itraconazole | DRUG | Itraconazole |
| Rifampin | DRUG | Rifampin |
| Midazolam | DRUG | Midazolam |
| Digoxin | DRUG | Digoxin |
| Metformin | DRUG | Metformin |
| Rosuvastatin | DRUG | Rosuvastatin |
Inclusion Criteria: * Participant has physical exam, vital signs, clinical laboratory safety and other medical test results that are within normal limits, considered not clinically significant by the Investigator, or within other parameters specified in the protocol * Body mass index of 18 to 32 kg...
BMS-986371 is an investigational small molecule being developed by Bristol-Myers Squibb Company. It has been studied in a Phase 1 clinical trial involving healthy adult male participants in the United States. The compound is not approved for any indication and remains in early clinical development.
BMS-986371 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the Phase 1 study of the compound conducted in the United States.
BMS-986371 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound is investigational and has not been approved by the FDA for any indication.
BMS-986371 has been evaluated in one completed Phase 1 trial, NCT05445440, titled a study to assess the effects of BMS-986371 on the drug levels of methotrexate in the presence and absence of sulfasalazine. The trial enrolled 30 healthy male participants aged 18 years and older in the United States.
The completed Phase 1 trial NCT05445440 examined the effects of BMS-986371 on the drug levels of methotrexate when given with and without sulfasalazine. It was a controlled study in 30 healthy male volunteers aged 18 years and older, conducted in the United States.