Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this study, the researchers will compare 2 new tablet forms of BAY2731954 with liquid oral forms of BAY2731954. A maximum of 61 healthy volunteers aged 18 to 55 will be asked to participate.
The study will have 2 parts. In part 1 researchers want to gather information how the body absorbs, distributes and excretes the drug BAY2731954 given as two different tablet formulations. Participants will take the study drugs on 3 days separated by breaks of at least 3 days between each intake. The duration of this study part will be in total of up to 6 weeks from first screening visit to follow-up visit.
In part 2 of the study researchers want to study how the body absorbs, distributes and excretes the drug BAY2731954 given as two different tablet formulations with or without food or as 2 liquid oral formulations. Participants will take the study drugs on 4 days separated by breaks of at least 3 days between each intake. The duration of the second part of study part will be in total of up to 7 weeks from first screening visit to follow-up visit.
During the study, researchers will collect blood and urine samples. In addition, doctors will check the participants' overall health. They will also ask the participants if they have any medical problems.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selitrectinib (BAY2731954) Adult tablet | Drug | Tablet, oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC | 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 | Up to 48 hours after dosing |
| AUC(0-24) | 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 | Up to 24 hours after dosing |
| Cmax | 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 | Up to 48 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | Area under the plasma concentration vs. time curve from 0 to infinity after single dose. To evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral solution | Up to 48 hours after dosing |
| AUC(0-24) |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International - Los Angeles | Glendale | California | 91206 | United States | ||
| PAREXEL International, Baltimore |
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal
Not provided
Not provided
Not provided
Not provided
Not provided
Part 1: sequential and non-randomized design Part 2: cross-over and randomized design
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| 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 |
|
Area under the plasma concentration vs. time curve from 0 to 24 hours after single dose
To evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral solution
| Up to 24 hours after dosing |
| Cmax | Maximum observed drug concentration in measured matrix after single dose administration To evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral solution | Up to 48 hours after dosing |
| Number of participants with treatment emergent adverse events and severity of treatment emergent adverse events | Adverse events that occur or worsen after the first dose of study medication | Up to 7 weeks |
| Incidence of laboratory abnormalities, based on clinical safety laboratory assessments | Hematology, clinical chemistry and urinalysis test results | Up to 7 weeks |
| Ventricular rate | Up to 7 weeks |
| ECG PR interval | Up to 7 weeks |
| ECG QT interval | Up to 7 weeks |
| ECG QRS duration | Up to 7 weeks |
| Blood pressure in mmHg | Up to 7 weeks |
| Heart rate in bpm | bpm: beats per minute | Up to 7 weeks |
| Body temperature in Celsius | Up to 7 weeks |
| Respiratory rate in breaths/min | Up to 7 weeks |
| Baltimore |
| Maryland |
| 21225 |
| United States |
| ID | Term |
|---|---|
| C000629855 | selitrectinib |
| D012996 | Solutions |
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
Not provided
Not provided