Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Entrectinib Form A · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Form A to Form C Crossover | EXPERIMENTAL | Participants first randomized to this arm will receive a single oral dose of entrectinib form A (reference form) under fasted conditions on Day 1 of each Period. This dose will be followed by a minimum 14-day washout period, after which participants will receive a single oral dose of entrectinib form C (test form) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days). |
| Form C to Form A Crossover | EXPERIMENTAL | Participants first randomized to this arm will receive a single oral dose of entrectinib form C (test form) under fasted conditions on Day 1 of each Period. This dose will be followed by a minimum 14-day washout period, after which participants will receive a single oral dose of entrectinib form A (reference form) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days). |
| Name | Type | Description |
|---|---|---|
| Entrectinib Form A | DRUG | Participants will receive a single oral dose of entrectinib form A under fasted conditions. |
| Entrectinib Form C | DRUG | Participants will receive a single oral dose of entrectinib form C under fasted conditions. |
Inclusion Criteria: * Healthy in the opinion of the investigator. Healthy is defined by the absence of evidence of any active disease or clinically significant medical condition based on a detailed medical history and examination * Negative test results for Hepatitis B, Hepatitis C, and Human Immun...
Entrectinib Form A is an investigational small molecule being studied in healthy volunteers. It is a specific crystalline form of entrectinib, and the completed Phase 1 trial assessed its bioequivalence compared to another form, Form C, under fasted conditions. It is not approved for any indication.
Entrectinib Form A is being developed by Roche Holding AG, traded on the OTC market under the ticker RHHBY. Roche conducted a Phase 1 study to compare this form with Entrectinib Form C in healthy subjects.
Entrectinib Form A is in Phase 1 clinical development. The single trial, NCT03796013, has been completed. As an investigational drug, it is not FDA approved and remains in early-stage clinical testing.
Entrectinib Form A has one completed clinical trial, NCT03796013, titled "A Study to Investigate the Bioequivalence of Two Different Forms of Entrectinib (Forms A and C) Under Fasted Conditions in Healthy Subjects." The study enrolled 28 participants in the United States.
No, Entrectinib Form A and Entrectinib Form C are different forms of the same drug. The Phase 1 trial NCT03796013 was designed to compare their bioequivalence under fasted conditions in healthy volunteers, indicating they are distinct formulations being evaluated for similarity.