Status:
COMPLETED
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
Lead Sponsor:
Bayer
Conditions:
Solid Tumors Harboring NTRK Fusion
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
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 th...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04275960
Start Date
February 28 2020
End Date
November 30 2020
Last Update
December 29 2020
Active Locations (1)
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1
CRS Clinical-Research-Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, Germany, 68167