check_circleStudy Completed

Solid Tumors Harboring NTRK Fusion

Bayer Identifier:

21416

ClinicalTrials.gov Identifier:

NCT04771390

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - 55 Years
  • Key :
    - 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

Trial summary

Enrollment Goal
52
Trial Dates
February 2021 - July 2021
Phase
Phase 1
Could I Receive a placebo
No
Products
selitrectinib (LOXO-195, BAY2731954)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Parexel International - Los AngelesGlendale, 91206, United States
Completed
PAREXEL International, BaltimoreBaltimore, 21225, United States

Primary Outcome

  • 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime Frame:
    Up to 48 hours after dosing

Secondary Outcome

  • 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime Frame:
    Up to 7 weeks
  • Incidence of laboratory abnormalities, based on clinical safety laboratory assessments
    Hematology, clinical chemistry and urinalysis test results
    date_rangeTime Frame:
    Up to 7 weeks
  • Ventricular rate
    date_rangeTime Frame:
    Up to 7 weeks
  • ECG PR interval
    date_rangeTime Frame:
    Up to 7 weeks
  • ECG QT interval
    date_rangeTime Frame:
    Up to 7 weeks
  • ECG QRS duration
    date_rangeTime Frame:
    Up to 7 weeks
  • Blood pressure in mmHg
    date_rangeTime Frame:
    Up to 7 weeks
  • Heart rate in bpm
    bpm: beats per minute
    date_rangeTime Frame:
    Up to 7 weeks
  • Body temperature in Celsius
    date_rangeTime Frame:
    Up to 7 weeks
  • Respiratory rate in breaths/min
    date_rangeTime Frame:
    Up to 7 weeks

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
9