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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 a small molecule drug candidate developed by Roche Holding AG. It is an investigational form of entrectinib that has been studied in a Phase 1 clinical trial in healthy volunteers. It has not been approved by the FDA and remains in clinical development.
Entrectinib Form A targets ALK, ROS1, and the NTRK family of receptors, specifically NTRK1, NTRK2, and NTRK3. It is classified as an inhibitor of these targets. By inhibiting these kinases, the drug is designed to interfere with signaling pathways driven by these molecular targets.
Entrectinib Form A is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor responsible for the clinical development of this investigational small molecule drug candidate.
Entrectinib Form A is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program for this form has completed its single registered trial, and no active trials are currently listed.
Entrectinib Form A has been evaluated in one completed Phase 1 trial, NCT03796013. That study investigated the bioequivalence of two different forms of entrectinib, Forms A and C, under fasted conditions in healthy subjects. It enrolled 28 participants in the United States and used a randomized, controlled design.
Entrectinib Form A is a specific form of entrectinib, studied alongside Form C in a bioequivalence trial. The two forms were compared under fasted conditions in healthy volunteers to assess whether they behave equivalently in the body. Entrectinib Form A is not a separate drug entity but a distinct form of the same compound.