Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational small molecule being developed for solid tumors harboring NTRK fusion. It is currently in Phase 1 clinical development, meaning it has not been approved by the FDA and is still being studied for safety and efficacy.
Selitrectinib Adult is being developed by Bayer AG, which trades under the ticker BAYRY. The company is conducting clinical research on this investigational oncology drug for solid tumors harboring NTRK fusion.
Selitrectinib Adult is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The single completed Phase 1 trial studied how the body absorbs, distributes, and excretes the drug in healthy participants.
Selitrectinib Adult has one completed clinical trial, NCT04771390, a Phase 1 study in the United States. The trial enrolled 52 healthy adult participants and compared different tablet and liquid formulations of selitrectinib, including the effect of food on drug absorption.
Yes, Selitrectinib Adult is also known as BAY2731954. The clinical trial NCT04771390 refers to the drug as selitrectinib (BAY2731954), confirming that these names refer to the same investigational compound.