Study Completed

Solid Tumors Harboring NTRK Fusion

Bayer Identifier:

21122

ClinicalTrials.gov Identifier:

NCT04275960

EudraCT Number:

2019-003870-23

EU CT Number:

Not Available

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

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years

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

Trial Dates

February 2020 - November 2020

Phase

Phase 1

Could I Receive a placebo

Products

selitrectinib (LOXO-195, BAY2731954)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	CRS Clinical-Research-Services Mannheim GmbH	Mannheim, 68167, Germany

Primary Outcome

Maximum concentration of selitrectinib in plasma in fasted state (Cmax_fasted)
Time Frame:
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)
Time Frame:
Up to 1 day
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
Maximum concentration of selitrectinib in plasma in fed state (Cmax_fed)
Time Frame:
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)
Time Frame:
Up to 1 days
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 Outcome

Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame:
Up to 23 weeks

Trial design

An open-label, non-randomized, Phase I study to evaluate the pharmacokinetics of selitrectinib (BAY 2731954) and food effects in healthy adult male participants

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Basic Science

Allocation

Non-randomized

Blinding

N/A

Assignment

Sequential Assignment

Trial Arms