Clinical trial NCT04771390: 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
Official title: An Open-label, Phase I Study to Evaluate the Relative Bioavailability, Food Effect and Pharmacokinetic Linearity of 2 New Tablet Formulations (Adult and Pediatric) of Selitrectinib (BAY 2731954) in Relative to Oral Suspension and the Liquid Service Formulation in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors Harboring NTRK Fusion
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2021-02-25
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Part 1: sequential and non-randomized design Part 2: cross-over and randomized design
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: AUC
timeFrame: Up to 48 hours after dosing
measure: AUC(0-24)
timeFrame: Up to 24 hours after dosing
measure: Cmax
timeFrame: Up to 48 hours after dosing
Secondary outcomes:
measure: AUC
timeFrame: Up to 48 hours after dosing
measure: AUC(0-24)
timeFrame: Up to 24 hours after dosing
measure: Cmax
timeFrame: Up to 48 hours after dosing
measure: Number of participants with treatment emergent adverse events and severity of treatment emergent adverse events
timeFrame: Up to 7 weeks
measure: Incidence of laboratory abnormalities, based on clinical safety laboratory assessments
timeFrame: Up to 7 weeks
measure: Ventricular rate
timeFrame: Up to 7 weeks
measure: ECG PR interval
timeFrame: Up to 7 weeks
measure: ECG QT interval
timeFrame: Up to 7 weeks
measure: ECG QRS duration
timeFrame: Up to 7 weeks
measure: Blood pressure in mmHg
timeFrame: Up to 7 weeks
measure: Heart rate in bpm
timeFrame: Up to 7 weeks
measure: Body temperature in Celsius
timeFrame: Up to 7 weeks
measure: Respiratory rate in breaths/min
timeFrame: Up to 7 weeks
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Parexel International - Los Angeles
state: California
city: Baltimore
country: United States
facility: PAREXEL International, Baltimore
state: Maryland
Study officials:
References: