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Also known as BMS-986368, CC-97489
Irafamdastat · 4 trials · 4 indications
The CMAI is a scale administered by qualified rater based on caregiver's input on 29 items that assess the frequency of manifestations of agitated behaviors in older adults. Each item is rated on a 7-point scale: 1 = "never", 2 = "less than once a week", 3 = "once or twice a week", 4 = "several times a week", 5 = "once or twice a day", 6 = "several times a day" and 7 = "several times per hour." Ratings pertain to the period of time over the previous 2 weeks preceding administration of the CMAI. CMAI total scores range from 29 to 203.
| Arm | Type | Description |
|---|---|---|
| BMS-986368 Dose 1 | EXPERIMENTAL | - |
| BMS-986368 Dose 2 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Administration of BMS-986368 Dose A | EXPERIMENTAL | - |
| Administration of BMS-986368 Dose B | EXPERIMENTAL | - |
| Administration of BMS-986368 Dose C | EXPERIMENTAL | - |
| Treatment A | EXPERIMENTAL | - |
| Treatment B | EXPERIMENTAL | - |
| Treatment C | EXPERIMENTAL | - |
| Treatment D | EXPERIMENTAL | - |
| Treatment E | EXPERIMENTAL | - |
| Part 1 | EXPERIMENTAL | - |
| Part 2 | EXPERIMENTAL | - |
| Part 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BMS-986368 | DRUG | Specified dose on specified days |
| Placebo | DRUG | Specified dose on specified days |
| Irafamdastat | DRUG | Specified dose on specified days. |
| CC-97489 | DRUG | Specified dose on specified days |
| [18F]T-401 | DRUG | Specified dose on specified days |
| [11C]MK-3168 | DRUG | Specified dose on specified days |
Inclusion Criteria * Participants with a diagnosis of Alzheimer's disease with biomarker confirmation meeting the 2024 Revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup. * The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) defi...
Irafamdastat is an investigational small-molecule drug being developed by Bristol-Myers Squibb under the code BMS-986368. It is in Phase 1 clinical development and is being studied in healthy adult volunteers. Its therapeutic indications have not been disclosed.
Irafamdastat belongs to the -stat enzyme inhibitor class, meaning it is designed to act on an enzyme target. Bristol-Myers Squibb is developing it as a small molecule in this enzyme-inhibitor category. The specific enzyme it inhibits has not been publicly disclosed.
Irafamdastat is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The compound is also identified by the code BMS-986368 in company and clinical trial documentation.
Irafamdastat is in Phase 1 clinical development. It is investigational and is being evaluated in early-stage human studies, including a pharmacokinetic trial in healthy adult participants. It has not completed later-stage trials.
Irafamdastat is being studied in trial NCT07837115, a Phase 1 study assessing the relative bioavailability of irafamdastat (BMS-986368) and the food effect on its pharmacokinetics in healthy adult participants. The trial is recruiting in the United States and plans to enroll 24 participants.
Yes, Irafamdastat and BMS-986368 refer to the same investigational compound. Bristol-Myers Squibb uses BMS-986368 as the development code for irafamdastat, and the name appears alongside the code in the Phase 1 bioavailability and food-effect trial in healthy volunteers.