Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01954043 | A Pharmacokinetics (PK) Study of the Effects Rabeprazole and Rifampin on Dabrafenib in Subjects With BRAF V600 Mutation Positive Tumors | PHASE1 | COMPLETED | 23 | — | — | Dec 20, 2013 | Feb 29, 2016 | Nov 14, 2017 | 6 | United States, Australia +1 |
Blood samples will be collected to assess PK parameters including: maximum observed concentration (Cmax)
Blood samples will be collected to assess PK parameters including: time to Cmax (tmax)
Blood samples will be collected to assess PK parameters including: area under the concentration-time curve over the dosing interval (AUC\[0-tau\])
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Subjects will administer Dabrafenib from Day 1 to Day 15, Dabrafenib and Rabeprazole from Day 16 to Day 19, Dabrafenib and Rifampin from Day 20 to Day 29. The serial PK samples will be collected for 12 hours following dosing on Day 15 (Dabrafenib alone), Day 19 (Dabrafenib and Rabeprazole), and Day 29 (Dabrafenib and Rifampin). |
| Name | Type | Description |
|---|---|---|
| Dabrafenib 150 mg twice a day (BID) | DRUG | Dabrafenib dosed at 150mg twice a day from Day 1 to the morning of Day 29 |
| Rabeprazole 40 mg once daily (OD) | DRUG | Rabeprazole dosed at 40mg each morning on Days 16 to 19 |
| Rifampin 600 mg OD | DRUG | Rifampin dosed at 600mg each morning on Days 20 to 29 |
Inclusion Criteria: * Male or female at least 18 years of age at the time of signing the informed consent form. * Provided signed written informed consent. * Capable of compliance with the requirements and restrictions listed in the consent form. * Body weight \>=45 kilogram (kg) and a body mass in...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520 / GEH200521 - Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | — | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |