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

Bayer52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Solid Tumors Harboring NTRK Fusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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, with body weight ≥50 kg * Use of adequate contraception until 3 months after last study intervention Key Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Up to 48 hours after dosing

Secondary Outcomes

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

Time frame: 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 relative bioavailability of adult tablet and pediatric tablet formulation vs oral solution

Time frame: 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

Time frame: 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

Time frame: Up to 7 weeks

Incidence of laboratory abnormalities, based on clinical safety laboratory assessments

Hematology, clinical chemistry and urinalysis test results

Time frame: Up to 7 weeks

Ventricular rate

Time frame: Up to 7 weeks

ECG PR interval

Time frame: Up to 7 weeks

ECG QT interval

Time frame: Up to 7 weeks

ECG QRS duration

Time frame: Up to 7 weeks

Blood pressure in mmHg

Time frame: Up to 7 weeks

Heart rate in bpm

bpm: beats per minute

Time frame: Up to 7 weeks

Body temperature in Celsius

Time frame: Up to 7 weeks

Respiratory rate in breaths/min

Time frame: Up to 7 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes