Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CC-90001 · 7 trials · 6 indications
Total \[14C\]-Radioactivity (RA) in whole blood, plasma, urine, and feces) will be measured via Liquid scintillation counting (LSC)
The total recovery of radioactivity will be computed as the sum of the cumulative excretion (as % dose) in urine and feces
Total \[14C\]-RA in whole blood and plasma will be converted to ngEq/mL concentration of \[14C\]CC-90001 based on specific activity of the dose. Equivalent concentration-time profiles will be determined.
The RA will be determined for CC-90001 and any identified metabolites in plasma. Metabolite profiling may use pooled time points.
Percentage of the administered dose, and the RA, will be determined for CC-90001 and any identified metabolites in urine and feces. Metabolite profiling may use pooled collection intervals.
Observed maximum concentration of \[14C\]CC-90001 and for metabolites with sufficient measurable concentration
Area under the concentration-time curve of \[14C\]CC-90001 and for metabolites with sufficient measureable concentration
Time to Cmax of \[14C\]CC-90001 and for metabolites with sufficient measureable concentration
Terminal elimination half-life of \[14C\]CC-90001 and for metabolites with sufficient measureable concentration
Area under the plasma concentration-time curve from time zero to the time point of the last measurable concentration
Area under the plasma concentration-time curve from time zero to infinity
Estimation of apparent clearance of drug from plasma after extravascular administration
Estimation of apparent volume of distribution during the terminal phase
Estimation of observed maximum plasma concentration
Estimation of time to Cmax
Description: Estimation of terminal elimination half-life
Number of subjects with adverse events
Number of subjects experiencing dose interruptions, reductions, and discontinuation of CC-90001 secondary to an AE
Complete Physical Examinations
Heart rate (HR), respiratory rate, blood pressure (BP), and body temperature
Maximum observed plasma concentration
Time to Cmax
Area under the plasma concentration time curve from time zero extrapolated to infinity
Area under the plasma concentration time curve from time zero to the last quantifiable concentration
Area under the plasma concentration-time curve from time zero to tau, where tau is the dosing interval
Terminal phase elimination half-life
Apparent total plasma clearance when dosed orally
Apparent total volume of distribution when dosed orally, based on the terminal phase
For Part 1 only the Phospho-c-Jun IHC data will be subjectively scored on a scale of 0 to 4 based on the intensity and number of epidermal keratinocyte nuclei stained within the tissue section by trained individuals blinded to treatment.
Number of participants with adverse events
| Arm | Type | Description |
|---|---|---|
| Administration of [14C]CC-90001 | EXPERIMENTAL | A single oral dose of \[14C\]CC-90001, containing approximately 100 μCi of radioactivity, will be administered on Day1 under fasted conditions. |
| CC-90001 100 mg | EXPERIMENTAL | 100 mg of CC-90001 (once daily \[QD\] x 7 days) will be given orally |
| CC-90001 200 mg | EXPERIMENTAL | 200 mg of CC-90001 (once daily \[QD\] x 7 days) will be given orally |
| CC-90001 400 mg | EXPERIMENTAL | 400 mg of CC-90001 (once daily \[QD\] x 7 days) will be given orally |
| Administration of CC-90001 | EXPERIMENTAL | Single oral dose of 200 mg of CC-90001 |
| Part1:Omeprazole + Midazolam + Warfarin + Vitamin K + CC-90001 | EXPERIMENTAL | Patient will receive CC-90001, 20mg Omeprazole, 2mg Midazolam 10mg Warfarin and 10mg Vitamin K |
| Part 2- Rosuvastatin and CC-90001 | EXPERIMENTAL | Patients will receive CC-90001 and 10mg of Rosuvastatin |
| Part 3: Metformin + Digoxin and CC-90001 | EXPERIMENTAL | Patients will receive CC-90001, 500mg Metformin and 0.25mg, Digoxin |
| Part 4: Nintedanib and CC-90001 | EXPERIMENTAL | Patients will receive CC-90001 and 100mg of Nintedanib |
| Low dose CC-90001 | EXPERIMENTAL | Low dose (100 mg) CC-90001 administered orally once daily (QD) for 12 continuous weeks |
| High dose CC-90001 | EXPERIMENTAL | High-dose (200 mg) CC-90001 administered orally Once Daily (QD) for 12 continuous weeks |
| CC-90001 | EXPERIMENTAL | Part 1: All subjects will receive the following doses of CC-90001 in the fixed sequence below: Treatment A: 60 mg CC-90001 as Active-Ingredient-in-Capsule, once daily x 6 days Treatment B: 160 mg CC-90001 as Active-Ingredient-in-Capsule, once daily x 6 days Treatment C: 400 mg of CC-90001 as Active-Ingredient-in-Capsule, once daily x 6 days |
| CC-90001 2 X 100mg fasted | EXPERIMENTAL | Treatment D: 2 x 100 mg CC-90001 as Active-Ingredient-in-Capsule, single oral dose administered under fasted conditions. |
| CC-90001 1 X 200mg fasted | EXPERIMENTAL | Treatment E: 1 x 200 mg CC-90001 \[formulated tablet(s)\] single oral dose administered under fasted conditions |
| CC-90001 1 X 200mg fed | EXPERIMENTAL | Treatment F: 1 x 200 mg CC-90001 \[formulated tablet(s)\] single oral dose administered under fed conditions (standard high fat breakfast). |
| CC-90001 10mg (Single Dose) | EXPERIMENTAL | - |
| CC-90001 30mg (Single Dose) | EXPERIMENTAL | - |
| CC-90001 60mg (Single Dose) | EXPERIMENTAL | - |
| CC-90001 120mg (Single Dose) | EXPERIMENTAL | - |
| CC-90001 240mg (Single Dose) | EXPERIMENTAL | - |
| CC-90001 10mg (Multiple Doses) | EXPERIMENTAL | - |
| CC-90001 30mg (Multiple Doses) | EXPERIMENTAL | - |
| CC-90001 60mg (Multiple Doses) | EXPERIMENTAL | - |
| CC-90001 120mg (Multiple Doses) | EXPERIMENTAL | - |
| CC-90001 240mg (Multiple Doses) | EXPERIMENTAL | - |
| Placebo | EXPERIMENTAL | - |
| CC-90001 480mg (single dose) | EXPERIMENTAL | CC-90001 480mg will be administered as a single oral dose |
| CC-90001 720mg (single dose) | EXPERIMENTAL | CC-90001 720mg will be administered as a single oral dose |
| CC-90001 480mg (multiple doses) | EXPERIMENTAL | CC-90001 480mg will be administered daily for 14 days |
| Name | Type | Description |
|---|---|---|
| [14C]CC-90001 | DRUG | Oral |
| CC-90001 | DRUG | CC-90001 |
| Omeprazole | DRUG | Omeprazole |
| Midazolam | DRUG | Midazolam |
| Warfarin | DRUG | Warfarin |
| Vitamin K | DIETARY_SUPPLEMENT | Vitamin K |
| Rosuvastatin | DRUG | Rosuvastatin |
| Metformin | DRUG | Metformin |
| Digoxin | DRUG | Digoxin |
| Nintedanib | DRUG | Nintedanib |
| Placebo | DRUG | Placebo will be administered once daily for up to 14 days depending on the Part of the study |
Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject is ≥18 and ≤55 years of age, from any race, at the time of signing the informed consent form (ICF). 2. Subject is a male. 3. Subject must understand and voluntarily sign an ICF prior to any stu...
CC-90001 is an investigational small molecule being studied in healthy volunteers for conditions including pulmonary fibrosis and hepatic impairment. It is in Phase 1 clinical development and is not approved for any use. All completed trials to date have involved healthy subjects to evaluate safety, tolerability, and pharmacokinetics.
CC-90001 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting Phase 1 clinical trials of this investigational small molecule in healthy volunteer populations.
CC-90001 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All four clinical trials listed for CC-90001 are Phase 1 studies that have been completed, with no active trials currently ongoing.
CC-90001 has completed four Phase 1 trials: NCT02110420, a first-in-human study of single and multiple ascending doses in healthy volunteers; NCT03363815, a drug interaction study with multiple medications; NCT03958864, a study in Japanese and Caucasian healthy subjects; and NCT04655898, a metabolism and excretion study in healthy males.
No alternative names for CC-90001 have been identified in the available information. The drug is referred to solely as CC-90001 across all clinical trial records and development documentation provided.