Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CC-99677 · 5 trials · 2 indications
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 |
|---|---|---|
| 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 |
|---|---|---|
| CC-99677 | DRUG | Specified dose on specified days |
| Placebo | OTHER | Placebo |
| Oral Contraceptive (Ortho Tri-Cyclen or its generic equivalent) | DRUG | Daily |
| Methotrexate | DRUG | Methotrexate |
| Sulfasalazine | DRUG | Sulfasalazine |
| Itraconazole | DRUG | Itraconazole |
| Rifampin | DRUG | Rifampin |
| Midazolam | DRUG | Midazolam |
| Digoxin | DRUG | Digoxin |
| Metformin | DRUG | Metformin |
| Rosuvastatin | DRUG | Rosuvastatin |
Inclusion Criteria: * Healthy male participants * Body mass index of 18.0 to 33.0 kg/m\^2, inclusive Exclusion Criteria: * Any significant acute or chronic medical illness * Any major surgery within 4 weeks of intervention administration * History of any significant drug allergy Other protocol-d...
CC-99677 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with completed trials evaluating its safety, tolerability, pharmacokinetics, and potential drug interactions. It is not approved for any indication and remains in early-stage clinical research.
CC-99677 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting Phase 1 clinical trials of this investigational small molecule in healthy volunteer populations.
CC-99677 is in Phase 1 clinical development. All four of its clinical trials are completed, with a total enrollment of 145 participants. The drug is investigational and has not been approved by regulatory authorities.
CC-99677 has completed four Phase 1 trials: NCT04268394 evaluating cytochrome P450 and transporter interactions in the UK, NCT04718636 studying effects on an oral contraceptive in healthy females in the US, NCT04958291 assessing safety and pharmacokinetics in Japanese participants in the US, and NCT05284890 evaluating drug levels of a radiolabeled form in healthy males in the US.
No alternative names for CC-99677 have been disclosed. The drug is identified solely by its development code CC-99677 in clinical trial registrations and is being studied by Bristol-Myers Squibb.