Study to Compare How the Body Absorbs, Distributes and Excretes the Drug Selitrectinib (BAY2731954) Given as Two Different Tablet Formulations or as Liquid Formulations Including the Effect of Food on the Absorption, Distribution or Excretion of the Different Formulations in Healthy Participants
- Conditions
- Solid Tumors Harboring NTRK Fusion
- Interventions
- Registration Number
- NCT04771390
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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, with body weight ≥50 kg
- Use of adequate contraception until 3 months after last study intervention
Key
- Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (e.g. seizures) or other organs (e.g. diabetes mellitus).
- Medical history of risk factors for Torsades de pointes (e.g. family history of Long QT Syndrome) or other arrhythmias
- Known severe allergies, allergies requiring therapy with corticosteroids, non-allergic drug reactions, or (multiple) drug allergies (excluding untreated asymptomatic seasonal allergies such as non-severe hay fever during the time of study conduct).
- Regular use of medicines
- Regular alcohol consumption
- Smoking more than 5 cigarettes daily
- History of COVID-19 or current SARS-CoV-2 infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part 1: Group B Selitrectinib (BAY2731954) Pediatric tablet 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 1: Group A Selitrectinib (BAY2731954) Adult tablet 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 2 (Group A): Dose A-B-C-D Selitrectinib (BAY2731954) Oral suspension 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 D-C-B-A Selitrectinib (BAY2731954) Oral suspension Participants will receive dose D, C, B and A sequentially. The washing-out period between each dose is at least 3 days Part 2 (Group B): Dose A-B-C-D Selitrectinib (BAY2731954) Pediatric tablet 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 Selitrectinib (BAY2731954) Oral suspension 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 D-C-B-A Selitrectinib (BAY2731954) Pediatric tablet Participants will receive dose D, C, B and A sequentially. The washing-out period between each dose is at least 3 days Part 2 (Group A): Dose C-A-B-D Selitrectinib (BAY2731954) Adult tablet 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 A): Dose C-A-B-D Selitrectinib (BAY2731954) Oral suspension 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 Selitrectinib (BAY2731954) Oral suspension 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 Selitrectinib (BAY2731954) Pediatric tablet 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 Selitrectinib (BAY2731954) Oral suspension 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 A): Dose A-B-C-D Selitrectinib (BAY2731954) Adult tablet 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 A-B-C-D Selitrectinib (BAY2731954) Oral solution 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 Selitrectinib (BAY2731954) Oral solution 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 Selitrectinib (BAY2731954) Oral solution 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 C-A-D-B Selitrectinib (BAY2731954) Pediatric tablet 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 A): Dose B-C-A-D Selitrectinib (BAY2731954) Adult tablet 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 B-C-A-D Selitrectinib (BAY2731954) Oral suspension Participants will receive dose B, C, A and D sequentially. The washing-out period between each dose is at least 3 days
- Primary Outcome Measures
Name Time Method AUC Up to 48 hours after dosing 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 formulationsAUC(0-24) Up to 24 hours after dosing 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 formulationsCmax Up to 48 hours after dosing 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
- Secondary Outcome Measures
Name Time Method ECG QT interval Up to 7 weeks ECG QRS duration Up to 7 weeks ECG PR interval Up to 7 weeks AUC Up to 48 hours after dosing 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 solutionAUC(0-24) Up to 24 hours after dosing 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 solutionCmax Up to 48 hours after dosing 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 solutionNumber of participants with treatment emergent adverse events and severity of treatment emergent adverse events Up to 7 weeks Adverse events that occur or worsen after the first dose of study medication
Incidence of laboratory abnormalities, based on clinical safety laboratory assessments Up to 7 weeks Hematology, clinical chemistry and urinalysis test results
Ventricular rate Up to 7 weeks Blood pressure in mmHg Up to 7 weeks Heart rate in bpm Up to 7 weeks bpm: beats per minute
Body temperature in Celsius Up to 7 weeks Respiratory rate in breaths/min Up to 7 weeks
Trial Locations
- Locations (2)
PAREXEL International, Baltimore
🇺🇸Baltimore, Maryland, United States
Parexel International - Los Angeles
🇺🇸Glendale, California, United States