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Completed

NCT Number: NCT04275960

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical-Research-Services Mannheim GmbH

Mannheim, Baden-Wurttemberg, 68167, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Selitrectinib (BAY2731954)

Drug

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.

Other names: Tyrosine receptor kinase (TRK) inhibitor

Primary outcomes

  1. Maximum concentration of selitrectinib in plasma in fasted state (Cmax_fasted)

    Time frame: Up to 3 days

  2. Area under the concentration-time curve of selitrectinib in plasma from time 0 to 24 hours in fasted state (AUC(0-24)_fasted)

    Time frame: Up to 1 day

  3. Area under the concentration-time curve of selitrectinib in plasma from time 0 to infinity in fasted state (AUC_fasted)

    Time frame: Up to 3 days

  4. Maximum concentration of selitrectinib in plasma in fed state (Cmax_fed)

    Time frame: Up to 3 days

  5. Area under the concentration-time curve of selitrectinib in plasma from time 0 to 24 hours in fed state (AUC(0-24)_fed)

    Time frame: Up to 1 days

  6. Area under the concentration-time curve of selitrectinib in plasma from time 0 to infinity in fed state (AUC_fed)

    Time frame: Up to 3 days

Secondary outcomes

  1. Number of participants with treatment-emergent adverse events (TEAEs)

    Time frame: Up to 23 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 19, 2020
Registry last updated
Dec 29, 2020

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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