Study in Healthy Adult Male Participants to Gather Information How the Human Body Absorbs, Distributes and Excretes the Study Drug Selitrectinib Including the Effect of the Interaction of Food With the Study Drug on the Human Body

Study Overview
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Brief Summary
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The researchers in this study want to gather information in healthy adult male participants about how the human body absorbs, distributes and excretes the drug selitrectinib including the effect of the interaction of food with the study drug on the human body. Selitrectinib is a new drug under development for the treatment of patients with solid tumor caused by a genetic abnormality known as an NTRK gene fusion which cannot be cured by currently available treatment options or has spread to other parts of the body. The drug blocks the action of the NTRK gene fusion and prevents the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. Researchers also want to find out if the participants have any medical problems during this study. Participants in this study will receive the study drug twice with at least 6 days in between. The study drug will be taken orally as a liquid before or after meal. Observation will last for up to 8 weeks, and blood samples will be taken from the participants to measure the blood levels of the study drug.

Detailed Description
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The primary objectives of this study are to investigate the pharmacokinetics and the effect of food on the pharmacokinetics of selitrectinib after a single dose of the drug. Secondary objective is to assess the safety of selitrectinib after a single dose.

Official Title
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An Open-label, Non-randomized, Phase I Study to Evaluate the Pharmacokinetics of Selitrectinib (BAY 2731954) and Food Effects in Healthy Adult Male Participants

Conditions
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Solid Tumors Harboring NTRK Fusion

Intervention / Treatment
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* Drug: Selitrectinib (BAY2731954)


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm_25 + 75 mg (Fasted)<br>Healthy male participants receive a single dose of 25 mg selitrectinib (Period 1) and 75 mg selitrectinib (Period 2) in fasted state. | Drug: Selitrectinib (BAY2731954)<br>* Selitrectinib is administered orally as liquid suspension (20 mg/mL) on Day 1 of each period. Each period lasts 4 days, both periods of each arm are separated by at least 3 days.<br>* Other names: Tyrosine receptor kinase (TRK) inhibitor;|
| Experimental: Arm_50 + 50 mg (Fasted/Fed)<br>Healthy male participants receive a single dose of 50 mg selitrectinib in fasted state (Period 1) and 50 mg selitrectinib in fed state (Period 2). | Drug: Selitrectinib (BAY2731954)<br>* Selitrectinib is administered orally as liquid suspension (20 mg/mL) on Day 1 of each period. Each period lasts 4 days, both periods of each arm are separated by at least 3 days.<br>* Other names: Tyrosine receptor kinase (TRK) inhibitor;|
| Experimental: Arm_100 + 150 mg (Fasted)<br>Healthy male participants receive a single dose of 100 mg selitrectinib (Period 1) and 150 mg selitrectinib (Period 2) in fasted state. | Drug: Selitrectinib (BAY2731954)<br>* Selitrectinib is administered orally as liquid suspension (20 mg/mL) on Day 1 of each period. Each period lasts 4 days, both periods of each arm are separated by at least 3 days.<br>* Other names: Tyrosine receptor kinase (TRK) inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration of selitrectinib in plasma in fasted state (Cmax_fasted) |  | Up to 3 days | 
| Area under the concentration-time curve of selitrectinib in plasma from time 0 to 24 hours in fasted state (AUC(0-24)_fasted) |  | Up to 1 day | 
| Area under the concentration-time curve of selitrectinib in plasma from time 0 to infinity in fasted state (AUC_fasted) |  | Up to 3 days | 
| Maximum concentration of selitrectinib in plasma in fed state (Cmax_fed) |  | Up to 3 days | 
| Area under the concentration-time curve of selitrectinib in plasma from time 0 to 24 hours in fed state (AUC(0-24)_fed) |  | Up to 1 days | 
| Area under the concentration-time curve of selitrectinib in plasma from time 0 to infinity in fed state (AUC_fed) |  | Up to 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-emergent adverse events (TEAEs) |  | Up to 23 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers, Pharmacokinetics, Food-Drug Interactions, Advanced or metastatic solid tumors, Neurotrophic tyrosine receptor kinase (NTRK) gene fusion, Tyrosine receptor kinase (TRK), TRK inhibitor, Drug formulation, Liquid suspension