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Also known as Selitrectinib (BAY2731954) Adult tablet
Selitrectinib Adult · 1 trial · 1 indication
Area under the plasma concentration vs. time curve from 0 to infinity after single dose To evaluate the pharmacokinetic linearity of selitrectinib after a single dose of adult tablet and pediatric tablet and to evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral suspension formulation and the food effect on the bioavailability of 2 new tablet formulations
Area under the plasma concentration vs. time curve from 0 to 24 hours after single dose To evaluate the pharmacokinetic linearity of selitrectinib after a single dose of adult tablet and pediatric tablet and to evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral suspension formulation and the food effect on the bioavailability of 2 new tablet formulations
Maximum observed drug concentration in measured matrix after single dose administration To evaluate the pharmacokinetic linearity of selitrectinib after a single dose of adult tablet and pediatric tablet and to evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral suspension formulation and the food effect on the bioavailability of 2 new tablet formulations
| Arm | Type | Description |
|---|---|---|
| Part 1: Group A | EXPERIMENTAL | Participants will receive 3 single doses of selitrectinib in adult tablet formulation sequentially in 3 treatment periods. The washing-out period between each dose is at least 3 days |
| Part 1: Group B | EXPERIMENTAL | Participants will receive 3 single doses of selitrectinib in pediatric tablet formulation sequentially in 3 treatment periods. The washing-out period between each dose is at least 3 days |
| Part 2 (Group A): Dose A-B-C-D | EXPERIMENTAL | Participants will receive dose A, B, C and D sequentially. The washing-out period between each dose is at least 3 days |
| Part 2 (Group A): Dose B-C-A-D | EXPERIMENTAL | Participants will receive dose B, C, A and D sequentially. The washing-out period between each dose is at least 3 days |
| Part 2 (Group A): Dose C-A-B-D | EXPERIMENTAL | Participants will receive dose C, A, B and D sequentially. The washing-out period between each dose is at least 3 days |
| Part 2 (Group B): Dose A-B-C-D | EXPERIMENTAL | Participants will receive dose A, B, C and D sequentially. The washing-out period between each dose is at least 3 days |
| Part 2 (Group B): Dose B-D-A-C | EXPERIMENTAL | Participants will receive dose B, D, A and C sequentially. The washing-out period between each dose is at least 3 days |
| Part 2 (Group B): Dose C-A-D-B | EXPERIMENTAL | Participants will receive dose C, A, B and D sequentially. The washing-out period between each dose is at least 3 days |
| Part 2 (Group B): Dose D-C-B-A | EXPERIMENTAL | Participants will receive dose D, C, B and A sequentially. The washing-out period between each dose is at least 3 days |
| Name | Type | Description |
|---|---|---|
| Selitrectinib (BAY2731954) Adult tablet | DRUG | Tablet, oral administration |
| Selitrectinib (BAY2731954) Pediatric tablet | DRUG | Tablet, oral administration |
| Selitrectinib (BAY2731954) Oral solution | DRUG | Oral solution after reconstitution |
| Selitrectinib (BAY2731954) Oral suspension | DRUG | Oral suspension after reconstitution |
Key Inclusion Criteria: * Participants who are overtly healthy as determined by the investigator or medically qualified designee based on medical evaluation including medical history, laboratory tests, physical, cardiac and neurologic examination * Body mass index (BMI): ≥18.5 and ≤ 29.9 kg/m2, wit...
Selitrectinib Adult is being developed for the treatment of solid tumors that harbor NTRK fusions. It is an investigational therapy, meaning it has not been approved by regulatory authorities for any indication. The clinical program focuses on patients whose tumors carry these specific genetic alterations.
Selitrectinib Adult targets the tropomyosin receptor kinase (TRK) family of proteins, specifically NTRK1, NTRK2, and NTRK3. It acts as an inhibitor of these kinases. By inhibiting NTRK1, NTRK2, and NTRK3, the drug aims to block signaling pathways that drive tumor growth in cancers with NTRK gene fusions.
Selitrectinib Adult is being developed by Bayer AG, which trades under the ticker BAYRY. Bayer is responsible for the clinical development and potential commercialization of this investigational drug.
Selitrectinib Adult is in Phase 1 clinical development. The only listed trial for this formulation is a completed Phase 1 study. It is not approved by the FDA or any other regulatory agency for any indication.
Selitrectinib Adult has been evaluated in one completed Phase 1 trial, NCT04771390. This study compared how the body absorbs, distributes, and excretes two different tablet formulations and liquid formulations of selitrectinib (BAY2731954), including the effect of food on absorption. It enrolled 52 healthy participants in the United States.
Yes, Selitrectinib Adult is also known as Selitrectinib (BAY2731954) Adult tablet. BAY2731954 is the internal code used by Bayer for selitrectinib. The adult tablet refers to the oral tablet formulation developed for adult patients.