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Completed

NCT Number: 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

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.

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Key information

Conditions

Solid Tumors Harboring NTRK Fusion

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International - Los Angeles, Glendale, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selitrectinib (BAY2731954) Adult tablet

Drug

Tablet, oral administration

Selitrectinib (BAY2731954) Pediatric tablet

Drug

Tablet, oral administration

Selitrectinib (BAY2731954) Oral solution

Drug

Oral solution after reconstitution

Selitrectinib (BAY2731954) Oral suspension

Drug

Oral suspension after reconstitution

Primary outcomes

  1. AUC

    Time frame: 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 formulations

  2. AUC(0-24)

    Time frame: 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 formulations

  3. Cmax

    Time frame: 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 outcomes

  1. AUC

    Time frame: 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 solution

  2. AUC(0-24)

    Time frame: 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 solution

  3. Cmax

    Time frame: 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 solution

  4. Number of participants with treatment emergent adverse events and severity of treatment emergent adverse events

    Time frame: Up to 7 weeks

    Adverse events that occur or worsen after the first dose of study medication

  5. Incidence of laboratory abnormalities, based on clinical safety laboratory assessments

    Time frame: Up to 7 weeks

    Hematology, clinical chemistry and urinalysis test results

  6. Ventricular rate

    Time frame: Up to 7 weeks

  7. ECG PR interval

    Time frame: Up to 7 weeks

  8. ECG QT interval

    Time frame: Up to 7 weeks

  9. ECG QRS duration

    Time frame: Up to 7 weeks

  10. Blood pressure in mmHg

    Time frame: Up to 7 weeks

  11. Heart rate in bpm

    Time frame: Up to 7 weeks

    bpm: beats per minute

  12. Body temperature in Celsius

    Time frame: Up to 7 weeks

  13. Respiratory rate in breaths/min

    Time frame: Up to 7 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2021
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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