Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-933043 · 1 trial · 1 indication
AEs = Adverse Events
| Arm | Type | Description |
|---|---|---|
| Panel 1:BMS-933043(2mg)/Placebo+Antacid Buffer Solution | EXPERIMENTAL | BMS-933043 2 mg solution by mouth twice daily for 10 days OR Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days |
| Panel 2:BMS-933043(5mg)/Placebo+Antacid Buffer Solution | EXPERIMENTAL | BMS-933043 5 mg solution by mouth twice daily for 10 days OR Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days |
| Panel 3:BMS-933043(10mg)/Placebo+Antacid Buffer Solution | EXPERIMENTAL | BMS-933043 10 mg solution by mouth twice daily for 10 days OR Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days |
| Panel 4:BMS-933043(25mg)/Placebo+Antacid Buffer Solution | EXPERIMENTAL | BMS-933043 25 mg solution by mouth twice daily for 10 days OR Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days |
| Panel 5:BMS-933043(50mg)/Placebo+Antacid Buffer Solution | EXPERIMENTAL | BMS-933043 50 mg solution by mouth twice daily for 10 days OR Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days CSF sampling required |
| Panel 6:BMS-933043(100mg)/Placebo+Antacid Buffer Solution | EXPERIMENTAL | BMS-933043 100 mg solution by mouth twice daily for 10 days OR Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days |
| Panel 7:BMS-933043(200mg)/Placebo+Antacid Buffer Solution | EXPERIMENTAL | BMS-933043 200 mg solution by mouth twice daily for 10 days OR Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days |
| Panel 8:BMS-933043(25mg)/Placebo+Antacid Buffer Predose | EXPERIMENTAL | MAD Phase: Japanese Subjects. Cerebrospinal fluid (CSF) sampling not required BMS-933043 25 mg solution by mouth twice daily for 10 days OR Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days |
| Panel 9:BMS-933043(200mg)/Placebo+Antacid Buffer Predose | EXPERIMENTAL | Japanese Subjects. CSF sampling not required. BMS-933043 200 mg solution by mouth twice daily for 10 days OR Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days |
| Panel 10:BMS-933043(350mg)/Placebo+Antacid Buffer Predose | EXPERIMENTAL | BMS-933043 350 mg solution by mouth twice daily for 10 days OR Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days |
| CSF Panel:BMS-933043(MTD)/Placebo+Antacid Buffer Predose | EXPERIMENTAL | If Panel 5 does not run. CSF Sampling at steady state BMS-933043 maximum tolerated dose (MTD), solution by mouth twice daily for 10 days OR Placebo matching with BMS-933043 0 mg solution by mouth twice daily for 10 days Antacid Buffer Predose 150 mL solution by mouth twice daily for 10 days |
| Name | Type | Description |
|---|---|---|
| BMS-933043 | DRUG | - |
| Placebo matching with BMS-933043 | DRUG | - |
| Antacid Buffer Predose Solution | DRUG | - |
Inclusion Criteria: * Healthy subjects as determined by no clinically significant deviation from normal medical history, physical examination, ECGs and clinical laboratory determinations * Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive. BMI = weight (kg)/ \[height (m)\]2 * Normal Neurological E...
BMS-933043 is an investigational small molecule drug developed by Bristol-Myers Squibb for neurology indications. It has completed a Phase 1 clinical trial in healthy adult volunteers. The specific therapeutic indication has not been disclosed.
BMS-933043 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY.
BMS-933043 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational drug and has not been approved by the FDA.
BMS-933043 has been studied in one completed Phase 1 trial, NCT01605994, titled "Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-933043 in Healthy Subjects." The trial enrolled 115 healthy adult participants in the United States.
BMS-933043 is being investigated for neurology indications, but the specific condition or disease target has not been disclosed. The completed Phase 1 trial evaluated the drug in healthy adult volunteers rather than in patients with a particular neurological disorder.