Trial Condition(s):

Solid tumors harboring NTRK fusion

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

Bayer Identifier:

21416

ClinicalTrials.gov Identifier:

NCT04771390

EudraCT Number:

Not Available

Study Completed

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.

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

Trial Summary

Enrollment Goal
52
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
selitrectinib (LOXO-195, BAY2731954)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Parexel International - Los Angeles

Glendale, United States, 91206

Status
Completed
 
Locations

PAREXEL International, Baltimore

Baltimore, United States, 21225

Status
Completed
 

Trial Design